Clinical trial NCT02996591
Conditions: Nerve Block General Anesthesia Spinal Anesthesia Pain Postoperative Nausea and Vomiting
Keywords: Nerve Block General Anesthesia Spinal Anesthesia Pain Postoperative Nausea and Vomiting
Sponsor: Hospital for Special Surgery, New York
Start date: 2017-01-01; Completion date: 2017-05-01
Enrollment: 36 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if there is a difference in patient outcomes with general anesthesia versus spinal anesthesia when given in addition to popliteal and adductor canal nerve blocks for foot and ankle surgery. Popliteal and adductor canal nerve blocks are injections of local anesthetic agents near nerves in the back and front of the knee going to the foot and ankle that provide numbness during and after surgery. These peripheral nerve blocks offer good pain control and reduce the need for opioids (opioids are pain medications such as morphine, Dilaudid, and oxycodone). General anesthesia involves the flow of oxygen and anesthesia gas through a tube which, along with additional intravenous medications, causes unconsciousness and unawareness of sensations during surgery. Spinal anesthesia involves an injection of local anesthetic in the lower back, which causes numbness below the waist. In addition to spinal anesthesia, a sedative is typically given intravenously to cause relaxation and sleepiness throughout surgery.

General, spinal, and nerve block anesthesia are all routinely used for surgery at the Hospital for Special Surgery. General or spinal anesthesia is typically used in addition to peripheral nerve blocks during foot and ankle surgery to 1) allow the surgeons to use a thigh tourniquet to reduce bleeding, 2) provide anesthesia earlier, and 3) prevent unwanted movement. However, it is unclear whether general or spinal anesthesia provides better patient outcomes when given with peripheral nerve blocks. Some reports show that on its own, spinal anesthesia has advantages over general anesthesia in terms of side effects such as nausea and pain. However, these advantages may also be gained from combining peripheral nerve blocks with general anesthesia. Spinal anesthesia can be associated with headache and backache, although headache and backache can also happen after operations performed with general anesthesia. A previous study at the Hospital for Special Surgery showed low rates of nausea among patients who received nerve blocks with spinal anesthesia, and no nausea among patients who received a nerve block with general anesthesia. Therefore, the primary aim of this study is to determine if, as a treatment, either general or spinal anesthesia has advantages over the other treatment in terms of readiness for discharge, side effects, pain and patient satisfaction in an ambulatory foot and ankle population.

Detailed description:

Arms: arm 1: Ultrasound (US) guided sciatic nerve blocks in the popliteal fossa and adductor canal block with 25 mL and 10 mL, respectively, of 0.25% bupivacaine (plus 2 mg preservative-free (PF) dexamethasone / 30 ml), performed under procedural IV sedation protocol. IV sedation protocol: midazolam, 2-5 mg IV + Glycopyrrolate, 0.1 mg IV + Ketamine, 10-20 mg, + propofol as needed. Spinal protocol: 45-60 mg 1.5% mepivacaine, depending on the expected case duration (45 mg for cases with projected duration 1-2 hours, 60 mg for cases with projected duration 2-3 hours). Intraoperative sedation maintained with propofol infusion and ketamine, 10 mg/hr. arm 2: Ultrasound (US) guided sciatic nerve blocks in the popliteal fossa and adductor canal block with 25 mL and 10 mL, respectively, of 0.25% bupivacaine (plus 2 mg preservative-free (PF) dexamethasone / 30 ml), performed under procedural IV sedation protocol. IV sedation protocol: midazolam, 2-5 mg IV + Glycopyrrolate, 0.1 mg IV + Ketamine, 10-20 mg, + propofol as needed. General anesthesia protocol: After induction with propofol and insertion of the LMA, anesthesia maintained with titrated propofol infusion, sevoflurane, ketamine 10 mg/hr.
Interventions: intervention 1: 25 mL of 0.25% bupivacaine plus 2 mg preservative-free (PF) dexamethasone / 30 ml for popliteal nerve block intervention 2: 10 mL of 0.25% bupivacaine plus 2 mg preservative-free (PF) dexamethasone / 30 ml for adductor canal nerve block intervention 3: Midazolam, 2-5 mg IV + Glycopyrrolate, 0.1 mg IV + Ketamine, 10-20 mg + propofol as needed intervention 4: 45-60 mg of 1.5% mepivacaine for spinal anesthesia intervention 5: LMA insertion + titrated propofol infusion + sevoflurane + ketamine 10 mg/hr for general anesthesia
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None

Protocol documents:
Prot_SAP_001.pdf: 
Study Title: Spinal versus General Anesthesia with Popliteal and Adductor Canal Blocks for Ambulatory 
Foot and Ankle Surgery. A Double-Blinded Randomized Controlled Trial. 
 
NCT#: NCT02996591 
 
IRB#: 2016-0499 
 
Principal Investigator: Jacques T Ya Deau, MD PhD 
 
Study Contact: George Birch 
 
Contact Number: 212-774-7377 
 
Contact Email: birchg@hss.edu 
 
Date: 9/7/2018  
 


 
 
This is the first step in your Human Research Application. You will automatically be guided to 
the appropriate forms needed to complete your submission. 
1.0 Title: 
Spinal versus General Anesthesia with Popliteal and Adductor Canal Blocks for Ambulatory Foot and Ankle 
Surgery. A Double-Blinded Randomized Controlled Trial. 
* Short Title for EPIC: LMA vs Spinal F&A (If Not Applicable, please enter N/A) 
1/18/2017 Print: 2016-0499 - Spinal versus General Anesthesia with Popliteal and Adductor Canal Blocks for Ambulatory Foot 
and Ankle Surgery. A Double-Blinded... 
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Clinical Research Proposal 
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8.0 Select appropriate funding sources for this study: 
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Other Funding Sources: 
Note: If the funding source of the study is 'Industry Funded Support', Clinical Research 
Administration (CRA) will be notified. 
If your study requires CRA review, please upload applicable documents, including sponsor protocol, drug brochure, 
etc : Name Version LMA vs Spinal F&A Nursing Support Letter 0.01 
Help Help CRP Information 
1.0 The proposal should be submitted to the appropriate Clinical Review Panel (CRP) for 
scientific review. If you are unsure of which Clinical Review Panel to select, please contact 
Barbara Bosco at 212.606.1914 * Name Anesthesiology 
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elp Regulatory Status of Drugs and Devices 
1.0 The regulatory status of the drugs or devices in this research 
proposal is: Name Does not apply to this study 
Help Help Pharmacy Involvement / Impact to EPIC 
1.0 
Is this an inpatient study? 
Yes No 
2.0 * Will this study have Investigational Drug Service involvement? 
(Pharmacy will be purchasing/dispensing any medications being used and/or study requires 
placebo and patient randomization) 
Yes No 
3.0 
If the answer to either question is yes, please explain briefly below AND contact Mylinh Duong 
at 646.797.8410 (duongm@hss.edu) or Nicole Oliva at 646.797.8324 (OlivaN@hss.edu). 
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1/18/2017 Print: 2016-0499 - Spinal versus General Anesthesia with Popliteal and Adductor Canal Blocks for Ambulatory Foot 
and Ankle Surgery. A Double-Blinded... 
Date: Wednesday, January 18, 2017 10:33:58 AM 
Prin
t Close ID: 2016-0499 Section: PART I - Study Identification Information 
H
elp Study Locations 
1.0 Select the Research Facilities where this study will be 
conducted: Facility HSS 
1.1 If Other, please specify: 
2.0 * Is this a multi-Center study? 
No 
ID: 2016-0499 Section: PART II - Clinical Research Proposal - Nature of Study This 
section will be reviewed by the appropriate Clinical Review Panel. Each of the headings 
in this section must be addressed. 
H
elp Specific Aims or Research Questions 
1.0 What is the condition or intervention to be studied? 
General anesthesia with laryngeal mask airway (LMA) versus spinal anesthesia for foot and ankle surgery, with both 
groups receiving sciatic nerve blockade in the popliteal fossa plus adductor canal (‘saphenous’) block. 
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Please click Here for example. 
2.0 What is/are the research question(s)/specific aim(s)? Pose 
very specific questions that can be addressed within the proposed design of the study. Prioritize 
them in order of importance. 
1) Does general anesthesia with LMA decrease time until PACU discharge compared with spinal anesthesia (when 
both groups receive popliteal plus adductor canal blocks)? 
2) Is there a difference in post-operative pain, nausea, discomfort and needs or opioid consumption with LMA 
versus spinal anesthesia on top of blocks? 
3) Is there a difference in satisfaction from anesthesia with LMA versus spinal anesthesia on top of blocks? 
3.0 What is/are the hypothesis(es)? 
Our hypothesis is that general anesthesia with LMA with peripheral nerve blocks will be superior in time until 
PACU discharge (minimum clinically important difference of 45 minutes [Mulroy 2000]) compared to spinal 
anesthesia with peripheral nerve blocks. 
References: 
Mulroy MF, Larkin KL, Hodgson PS, Helman JD, Pollock JE, Liu SS. A comparison of spinal, epidural, and general 


anesthesia for outpatient knee 


1/18/2017 Print: 2016-0499 - Spinal versus General Anesthesia with Popliteal and Adductor Canal Blocks for Ambulatory Foot 
and Ankle Surgery. A Double-Blinded... 
ID: 2016-0499 arthroscopy. Section: Anesth PART Analg II 2000;91:860–4. 
- Clinical Research Proposal - Nature of Study 4.0 Identify and define the primary outcome and 
when the outcome will be measured. If measuring change in post- operative function is the most 
important, that will be your primary outcome. 
Time from admission to PACU until ready for discharge home (assessed by RA q 15 m) 
Criteria used: Modified Aldrete Scoring System (1) and Marshall and Chung Postanesthesia Discharge Scoring 
System(2) 
References: 
1. Aldrete JA. The post anesthesia recovery score revisited. J Clin Anesth 1995; 7:89-91 
2. Marshall S, Chung F: Assessment of “home readiness”: Discharge criteria and postdischarge complications. Curr 
Opin Anaesthesiol 1997; 10:445-50. 
5.0 Identify and define the secondary outcome(s) and when they 
will be measured (list additional goals one at a time with their corresponding outcomes). 
NRS pain at rest and with movement (pre-op, PACU, POD1). Patient satisfaction with perioperative care (POD1) 
Postoperative discomfort and needs (post-op pain, sore throat, back pain, headache, nausea, cold, hunger, thirst) 
(Pre-op, PACU, POD1) Nausea (Present/absent); if present: 0-10 scale (Preop, PACU, POD1) Headache 
(Present/absent); if present PDPH questionnaire (Preop, PACU, POD1) 
PDPH: post-dural puncture headache Backache (Present/absent); if present, TNS questionnaire (Preop, 
PACU, POD1) 
TNS: transient neurologic symptom Opioid consumption (Preop, PACU, POD1) Side effects (Opioid Related 
Symptom Distress Scale) (PACU, POD1) Unexpected adverse events, including ICU admission and postoperative 
complications (Intraop, PACU, POD1) Urinary catheterization (yes/no), time until voiding and volume of 
intake/output in PACU PQRS Cognitive domain (Preop, PACU, POD 1) Blinding of patient and research assistant 
(PACU) 
Help Help BACKGROUND - Be sure to answer each question individually 
1.0 Explain why these research questions are being asked: 
Popliteal and adductor canal peripheral nerve blocks (PNBs) provide good pain control for foot and ankle surgery. 
In the context of the peripheral nerve blocks, spinal anesthesia is typically added to (1) allow surgical use of a thigh 
tourniquet (2) provide faster onset (and potentially more reliable) surgical anesthesia and (3) ensure patient 
immobility. However, spinal anesthesia may prolong PACU discharge time and has associated side effects (back 
pain, headache, TNS – transient neurologic symptoms). General anesthesia also addresses the three concerns 
discussed previously (tourniquet, reliability, immobility) but when used alone is traditionally associated with higher 
pain scores, and more nausea. However, the combination of peripheral nerve blocks, general anesthesia (using 
Laryngeal Mask Airway, LMA), and prophylactic anti-emetics may 
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1/18/2017 Print: 2016-0499 - Spinal versus General Anesthesia with Popliteal and Adductor Canal Blocks for Ambulatory Foot 
and Ankle Surgery. A Double-Blinded... 
ID: 2016-0499 provide good Section: pain control PART with II - fewer Clinical side Research effects from 
Proposal the general - Nature anesthesia, of Study and hasten the 
discharge home as compared to spinal. 
2.0 What is the background of the topic that you believe is important for the reviewer to know in 
considering this protocol, including prior studies by this research team. Describe strengths and 
deficiencies of prior studies; explain how this study fits in. Include references. 
Peripheral nerve blocks (PNBs) have increased in popularity due to their efficacy and safety in providing 
postoperative analgesia by reducing pain, opioid consumption and side effects (1,2). PNBs are often combined with 
general anesthesia, or neuraxial anesthesia. It is not clear which of these accompaniments most improves the patient 
experience. When feasible, neuraxial anesthesia is often preferred over general anesthesia because of association 
with better perioperative outcomes (3). Neuraxial anesthesia may have fewer side effects, such as post-operative 
nausea and vomiting (PONV)(4) and confusion (5). Spinal anesthesia has advantages over general anesthesia in 
terms of pain, functional recovery and side effects for ambulatory lower limb surgery, in the absence of peripheral 
nerve blocks (PNB)(6,7). However, the presumed advantages of neuraxial anesthesia (minimized opioids, improved 
analgesia and reduced nausea) may possibly also be achieved by combining PNBs with general anesthesia. 
The previous non-randomized pilot study applied PNBs plus antiemetic prophylaxis and an opioid sparing protocol 
among foot and ankle patients (receiving spinal anesthesia plus blocks) and TSA patients (receiving general 
anesthesia or sedation plus blocks). Results showed low rates of nausea in all groups and no incidence of emesis in 
any groups. However, no previous studies have compared LMA general anesthesia to spinal anesthesia in the 
presence of a double block (popliteal + adductor canal) in terms of time to discharge home, satisfaction, severity of 
pain and PONV, and opioid consumption and side effects in an ambulatory foot and ankle population. 
References: 
1. Kessler J, Marhofer P, Hopkins PM, Hollmann MV. Peripheral regional anaesthesia and 
outcome: lessons learned from the past 10 years. Br J Anaesth 2015; 114: 728-45. 2. Liu SS, Strodtbeck WM, 
Richman JM, Wu CL. A comparison of regional versus general anesthesia for ambulatory anesthesia: a 
meta-analysis of randomized controlled trials. Anesth Analg 2005; 101: 1634–42. 3. Memtsoudis SG, Sun X, Chiu, 
YL, Stunder O, Liu SS, Banerjee S, Mazumdar M, 
Sharrock NE. Perioperative comparative effectiveness of anesthetic technique in orthopedic patients. Anesthesiology 
2013; 118: 1046-58. 4. Borgeat A, Ekatodramis G, Schenker CA. Postoperative nausea and vomiting in 
regional anesthesia: a review. Anesthesiology 2003; 98: 530-47. 5. Kettner, SC. Willschke H, Marhofer P. Does 
regional anaesthesia really improve 
outcome? Br J Anaesth 2011; 107: i90-5. 6. Standl T, Eckert S, Schulteam Esch J. Postoperative complaints after 
spinal and 
thiopentone-isoflurane anaesthesia in patients undergoing orthopaedic surgery. Spinal versus general anaesthesia. 
Acta Anaesthesiol Scand 1996; 40: 222-6. 7. Liu SS, Strodtbeck WM, Richman JM, Wu CL. A comparison of 
regional versus general anesthesia for ambulatory anesthesia: a meta-analysis of randomized controlled trials. 
Anesth Analg 2005; 101: 1634–42. 8. Luu, Roberts, Gadulov, Field, Kahn, Gulotta, Dines, Levine, LaSala, Gordon, 
Paroli, YaDeau. Recovery Profile among Orthopedic Patients Receiving Peripheral Nerve Blocks: Is General 
Anesthesia, Spinal Anesthesia or Sedation the Best Accompaniment? A Pilot Study. (Manuscript in preparation) 
3.0 Identify specific gaps in current knowledge that this study is intended to 
fill. 


This study will compare LMA general anesthesia to spinal anesthesia on top of popliteal plus adductor canal blocks 
for foot and ankle surgery in terms of discharge time, satisfaction and side effects, which has not been done before. 
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1/18/2017 Print: 2016-0499 - Spinal versus General Anesthesia with Popliteal and Adductor Canal Blocks for Ambulatory Foot 
and Ankle Surgery. A Double-Blinded... 
ID: 2016-0499 Section: PART II - Clinical Research Proposal - Nature of Study 
4.0 How will answering these questions change clinical practice, change concepts about the topic 
or confirm the work of other investigators? 
There is a possibility that in the setting of a double block for foot and ankle surgery, general anesthesia can shorten 
time to discharge without increasing side effects, compared to spinal anesthesia. This will hopefully lead to more 
investigative work on general anesthesia with nerve blocks vs spinal anesthesia with nerve blocks that might change 
the preference of clinicians when deciding upon the best anesthetic regimen for foot and ankle patients. 
5.0 Is this a pilot study that could lead to a more definitive protocol or 
different study? Yes No 
5.1 If you answered No, please explain below: 
This study is comparing two standard of care protocols and will provide information regarding the effectiveness of 
each. Therefore, this study will not lead to a more definitive protocol or different study. 
6.0 Please upload reference or additional document here (if needed). 
Name Description There are no items to display 
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1/18/2017 Print: 2016-0499 - Spinal versus General Anesthesia with Popliteal and Adductor Canal Blocks for Ambulatory Foot 
and Ankle Surgery. A Double-Blinded... 
ID: 2016-0499 Section: PART II - Clinical Research Proposal - Nature of Study 
H
elp Study Design 
1.0 
Observational: 
Name Description There are no items to display 
2.0 
Experimental: 
Name Description 
Randomized Controlled Clinical Trial 
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This is the “gold standard” for clinical research. These prospective studies have at least two groups. Patients meeting 
strict inclusion/exclusion criteria are enrolled and randomly assigned to receive either an experimental intervention 
or to receive what is considered to be an acceptable alternative – usually the current standard of care or a placebo 
(e.g., study of hylauronic acid injection versus cortisone for arthritis). 
2.1 If Other, please specify: 
2.2 If Randomized Controlled Clinical Trial is selected, please choose one of the following: 
Name Other 
If other, please list name or indicate N/A below: 
Standard of care general anesthesia with LMA and spinal anesthesia with popliteal and adductor canal nerve blocks 
ID: 2016-0499 Section: PART II - Clinical Research Proposal - Recruitment & Enrollment 
H
elp Recruitment 
1.0 
Check all that apply to describe your study population: 
Population Patients 
Vulnerable Populations There are no items to display 
1.1 If Other, please specify: 
2.0 Inclusion Criteria: list characteristics that potential subjects and 
controls need to have. Use a bullet format, if applicable. 
18-75 aged patients 


1/18/2017 Print: 2016-0499 - Spinal versus General Anesthesia with Popliteal and Adductor Canal Blocks for Ambulatory Foot 
and Ankle Surgery. A Double-Blinded... 
ID: 2016-0499 ASA1-3 
Section: PART II - Clinical Research Proposal - Recruitment & Enrollment Elective foot and ankle day surgery 
procedures, lasting between 1 and 3 hours as per surgeon, performed by 3 co-investigator surgeons. planned for 
combined popliteal and adductor canal block no contraindications for spinal or LMA general anesthesia 
3.0 
Exclusion Criteria: list characteristics that would cause you to exclude potential subjects and 
controls. 
Justify any age, ethnicity, language, or gender-based exclusion criteria. Use a bullet format, if 
applicable. 
Incapable of providing informed consent, contraindications for regional or LMA anesthesia (anticoagulation, 
infection at injection site) anticipated difficult airway, BMI>40, anticipated surgical procedure time less than 1 hour 
or more than 3 hours, Hx of severe PONV ASA >3, peripheral neuropathy affecting the operative extremity 
pregnant or nursing women, chronic opioid use (daily use of opioids one month prior to surgery/ patients requiring 
chronic pain interventions) prone position OSA with planned admission overnight to the hospital known 
allergy/sensitivity to any study medications planned admission after surgery Non-English speaking 
4.0 Age Range: 18-75 
5.0 Describe how you will identify and recruit potential subjects 
for participation in the study. 
Surgeon co-investigators will introduce the concept of the study to patients during a preoperative office visit. 
Potential patients will be identified on the schedule the day before surgery and approached in the holding area of the 
Hand and Foot Surgery Center, where informed consent will be obtained by a study staff working in conjunction 
with an attending physician participating in the study. Approximately 2-6 patients per week will be enrolled. 
6.0 * Please select enrollment type from following drop down list: 
Over Course of Study 
Help 
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1/18/2017 Print: 2016-0499 - Spinal versus General Anesthesia with Popliteal and Adductor Canal Blocks for Ambulatory Foot 
and Ankle Surgery. A Double-Blinded... 
ID: 2016-0499 Section: PART II - Clinical Research Proposal - Recruitment & Enrollment 
H
elp Patients 
1.0 Please check the box(es) below that best reflect how patients 
will be identifed and recruited for participation. 
How subjects will be identified Potential subjects will be identified after a review of medical records of patients 
under the care of one or more of the study investigators Medical records and/or other Institution sources 
(databases,registries,billing records,pathology reports,admission logs) will be reviewed to identify potential 
participants. May involve access of records by individuals not involved in the patient's care. Potential subjects will 
be identified by their treating physicians and referred to the researchers. Patients' private and identifiable 
information will not be shared prior to receiving permission from the patient to do so. Potential subjects will be 
identified from a registry of individuals interested in research opportunities. Subjects will roll-over from another 
research study. 
Potential subjects will self-refer in response to advertisements. 
H
elp Target Enrollment 
1.0 * What is the maximum number of subject you plan to enroll in 
this study at HSS?(Please enter a number) 36 
2.0 If this is a multi-center study, indicate the projected total 
subject accrual across all sites. 
H
elp ID: 2016-0499 Section: PART II - Clinical Research Proposal - Interventions or Observations 
H
elp Interventions and Observations 
1.0 
Be specific and describe the Interventions or Observations that will be part of this research 
project. Include a detailed description of the treatment arms, if applicable. 
Patients will be randomized into either the Spinal/Block Group or General Anesthesia/Block Group. The 
randomization will be performed by a research staff member not otherwise involved in the project. The patient and 
research staff performing assessments/administering questionnaires will be blinded to the group assignment. 
Intraop-protocol: 
Spinal/Block Group: Ultrasound (US) guided sciatic nerve blocks in the popliteal fossa and adductor canal block 
with 25 mL and 10 mL, respectively, of 0.25% bupivacaine (plus 2 mg preservative-free (PF) dexamethasone / 30 
ml), performed under procedural IV sedation protocol. IV sedation protocol: midazolam, 2-5 mg IV + 
Glycopyrrolate, 0.1 mg IV + Ketamine, 10-20 mg, + propofol as needed. Spinal protocol: 45-60 mg 1.5% 
mepivacaine, depending on the expected case duration (45 mg for cases with projected duration 1-2 hours, 60 mg 


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1/18/2017 Print: 2016-0499 - Spinal versus General Anesthesia with Popliteal and Adductor Canal Blocks for Ambulatory Foot 
and Ankle Surgery. A Double-Blinded... 
ID: 2016-0499 for cases with Section: projected PART duration II - Clinical 2-3 hours). Research Intraoperative 
Proposal - sedation Interventions maintained or Observations with propofol infusion and 
ketamine, 10 mg/hr (in addition to the 10-20 mg given for block sedation). 
General Anesthesia/Block Group. Blocks performed as above. General anesthesia protocol: After induction with 
propofol and insertion of the LMA, anesthesia maintained with titrated propofol infusion, sevoflurane, ketamine 10 
mg/hr (in addition to the 10-20 mg given for block sedation). 
Both groups will receive IV ondansetron (4 mg), famotidine (20 mg), dexamethasone (4 mg in addition to block 
dexamethasone) and ketorolac 30 mg (unless age>75 or weight<60 kg, then 15 mg). 
Post-op instructions: 
Opioids will not be administered intraoperatively until emergence from sedation (Spinal/Block Group) or from 
general anesthesia (General Anesthesia/Block group). Tourniquet-related stimuli (being transient in nature) will be 
addressed with propofol and ketamine (and sevoflurane in general anesthesia group). If patients appear to have 
surgical pain on emergence, IV hydromorphone will be given as needed (in 0.5 mg increments). 
Standardized post-op pain protocol: 
Narcotic of choice (Percocet, Norco, Oxycodone, Dilaudid, etc.) with a quantity of 60 pills DVT PPX of choice 
(aspirin, xarelto, lovenox, etc) Ibuprofen 200mg, take 3 tablets TID for a total of 3 days (quantity 27 pills) Zofran 
4mg PO q12h prn nausea for a 2 day supply (quantity 4 pills) No prescribed lyrica or gabapentin to patients enrolled 
Collection of outcomes: 
Demographics and baseline information (NRS pain, PONV, PQRS Cognitive Domain, backache and headache 
history, medication consumption, Leiden Discomfort and Needs) will be obtained in the holding area before surgery. 
After anesthesia end time, readiness for PACU discharge will be assessed every 15 minutes using the modified 
Aldrete scoring system. Once the modified Aldrete criteria is met, the patient will be assessed every 15 minutes 
using the Postanesthesia Discharge Scoring System, which will be used to determine final readiness for PACU 
discharge time. PACU nurses and physical therapists will assess and instruct the patient with the knowledge of 
whether the patient received general or spinal anesthesia, but they will be asked not to reveal to the patient which 
treatment he/she received. 
1 hour and 2 hours after PACU admission (or when ready for discharge), NRS pain, PONV, PQRS Cognitive 
Domain, and Leiden Discomfort and Needs will be assessed. Popliteal and adductor canal blocks will be assessed 
using an alcohol swab when either spinal wears off or sufficiently awakened from GA. When readiness for PACU 
discharge is met, ORSDS and blinding assessment will be administered. 
On POD 1, patients will be contacted by phone to collect NRS pain, PONV, PQRS Cognitive Domain, 
Backache/TNS and Headache/PDPH, medication consumption, ORSDS and Leiden questionnaire outcomes, as well 
as “If you need similar surgery in the future, would you request the same anesthetic that you received this time? 
(Yes/No)”. If TNS or PDPH is identified, patients will be followed up for duration of symptoms. 
Study-Specific Procedures 
Day Who? 
Before Surgery 
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Pre-op (Holding Area) 


PACU, 1 hour after admission 
PACU, 2 hours after admission 
PACU, ready for 
POD 1 discharge 
Identify eligible patients on schedule day before surgery. Confirm length of surgery. 
RA X 
Obtain consent 
Anes MD/ Surgeon 
X 
Assess readiness for PACU Discharge (q15 
RA X (if not met) X (if not met) X (if not met) 


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and Ankle Surgery. A Double-Blinded... 
ID: 2016-0499 min until criteria Section: met) 
PART II - Clinical Research Proposal - Interventions or Observations 
NRS pain, PONV, PQRS Cognitive RA Domain 
X X 
X (if not ready for discharge) 
X X 
Backache/TNS Headache/PDPH 
and 
RA X X 
Collect opioid and non-opioid consumption 
2.0 Will you be collecting human fluid or tissue? Yes No 
If yes, what will you be collecting? Fluid Tissue (Intraoperative and/or outpatient collection) 
Help Help Data Collection 
1.0 Indicate what data will be collected. 
Variable Time point(s) Data Source Who Collects? 
Demographics: DOB, MRN, Race, Ethnicity, BMI, Gender, Phone number 
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RA X 
X (for PACU duration) 
X 
ORSDS RA X X 
Leiden Perioperative care Patient Satisfaction questionnaire (LPPSq) 
RA X 
Leiden Discomfort and Needs 
RA X X 
X (if not ready for discharge) 
X X 
Block assessment RA 
X 
X (when spinal wears off or (Baseline 
awakened from reading) 
GA) 
Blinding Assessment RA X 


Pre-op Medical Record Research Assistant 
Comorbidities, Risk factors associated with outcomes 
Pre-op Medical Record Research Assistant 


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and Ankle Surgery. A Double-Blinded... 
ID: 2016-0499 Randomization/Group Section: PART assignment II - Clinical Pre-op Research Proposal - 
Interventions Randomization or Observations scheme 
Research Assistant created by staff member not involved in project 
ASA, Type of anesthesia, induction time, anesthesia start & end time, difficult spinal/general, TQ time 
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Intra-op Anesthesia Record Research Assistant 
Type of surgery, surgery start & end time 
Intra-op Medical Record Research Assistant 
Time from PACU admission to readiness for PACU discharge 
Patient: Aldrete score (Aldrete JA. The post- anesthesia recovery score revisited. J Clin PACU, every 15 minutes 
Anesth 1995) and after anesthesia end time 
Postanesthesia 
Research Assistant 
Discharge Scoring System (Marshall and Chung. Curr Opin Anesthesiol 1997) 
Opioid consumption Pre-op, PACU, POD 1 
Medical Patient 
Record and 
Research Assistant 
Opioid-related side effects PACU (2 hours), POD 1 
Patient: ORSDS (YaDeau et al. A&A 2011) 
Non-opioid analgesic medications Pre-op, PACU, POD 1 
Medical Patient 
Record and 
Research Assistant 
Pain at rest and with movement (at the time of questioning) 
Pre-op, PACU (1 hour and 2 hours), POD 1 
Patient: NRS (0-10) Research Assistant 
Nausea and vomiting 
Pre-op, PACU (1 hour Patient: and 2 hours), POD 1 
Incidence (yes/no) and severity 
Research Assistant (NRS) 
Postoperative Quality Recovery Scale (PQRS) Cognitive Domain 
Pre-op, PACU (1 hour and 2 hours), POD 1 
Patient: PQRS Research Assistant 


Satisfaction with perioperative care 
Patient: Leiden Perioperative care Patient Satisfaction questionnaire 
POD 1 
(LPPSq). questionnaire Full 
(Caljouw, 
Research Assistant 
Beuzekom, Boer. BJA 2008). Willingness to get same treatment again 
Postoperative discomfort and needs 
Patient: Leiden Perioperative care Patient 
Pre-op, PACU (1 hour and 2 hours) and POD 1 
Satisfaction questionnaire (LPPSq) (Caljouw, 
Research Assistant 


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and Ankle Surgery. A Double-Blinded... 
ID: 2016-0499 Section: PART II - Clinical Research Proposal - Interventions Beuzekom, or Boer. Observations BJA 
2008) 
Backache/TNS 
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Patient: If the backache question from LPPSq is negative, then no further questioning. If positive, then the TNS 
Pre-op, POD 1 and POD 
questionnaire will be 6-9 
administered. Duration 
Research Assistant 
will be determined from further follow-up as needed. (YaDeau, Liguori, Zayas. A&A 2005) 
Headache/ PDPH 
Patient: assess for PDPH, including new incidence of postural Pre-op, 6-9 
POD 1 and POD 
headache (yes/no), severity (NRS), duration. 
Research Assistant 
On POD6-9 will only ask about headache and backache. 
Incidence of urinary catherization, time until voiding and volume of intake/output 
PACU 
Medical (yes/no) 
record: Incidence 
Research Assistant 
Blinding assessment PACU Patient Research Assistant 
Block assessment Pre-op, PACU Patient Research Assistant 
Unexpected adverse events, including ICU admission 
Intra-op to POD 1 Medical Record Research Assistant 
2.0 Who will collect the data: 
Jacques YaDeau, MD, PhD IRB Vice Chair Angie Zhang Research Assistant Vincent Lasala, MD Thuyvan Luu 
Jodie Curren, RN Seong Jin Kim Senior Research Assistant Candace Gopaul Leonardo Paroli, MD Phuong Dinh 
Mac Kethy JulesElysee, MD Director of Pre-Anesthesia Screening George Birch Richard Kahn, MD 
3.0 When the data will be collected? Include timing of visits(either SOC or specifically 
for the study). Holding area, PACU, POD 1 
4.0 


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and Ankle Surgery. A Double-Blinded... 
ID: 2016-0499 From what Section: source: 
PART II - Clinical Research Proposal - Interventions or Observations Medical Records Patient 
No Private Office Charts Please specify which private office: 
No Registries Please specify which registry: 
Other Please specify: 
Help Help General Methods and Procedures 
1.0 * Are controls included in the study? No 
1.1 If yes, describe how they will be matched with the study subjects; state whether the controls will have identical 
data recorded, or describe any differences compared to the intervention subjects. 
2.0 
* Are all tests Standard of care? No 
If not, identify which tests are not standard of care. What source of funds will be used to pay for them (text box 
below): 
The surveys and questionnaires that will be administered by the research staff are not standard of care. The Hospital 
for Special Surgery Anesthesiology Department Research and Education Fund will be used to pay for them. 
3.0 * Will surveys/questionnaires be used? Yes 
4.0 * Does the study involve randomization? Yes 
5.0 * Does your study included Placebo or No-Treatment Arm? No 
6.0 * Does your study included Washout of Previous Medication? No 
7.0 Data collection sheet should be created for the study and uploaded: 
Name Version LMA vs Spinal F&A Data Collection Sheet 120116 0.02 LMA vs Spinal F&A Patient Information 
Sheet 0.01 LMA vs Spinal F&A REDCap 010417 0.04 
Help 
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and Ankle Surgery. A Double-Blinded... 
ID: 2016-0499 Section: PART II - Clinical Research Proposal - Interventions or Observations 
H
elp Surveys & Questionnaires 
1.0 Please add all survey instruments and questionnaires to be used in this 
study: 
Name 
Standard Instument 
Upload Instrument Usage of Instrument 
View 
Headache/PDPH Questionnaire 
no 
Headache/PDPH Questionnaire(0.01) 
This instrument will be screen for incidence of puncture headache (PDPH). 
used to post-dural 
This instrument will be used to View LLPSq yes 
LLPSq(0.01) 
collect satisfaction with perioperative care. 
View 
NRS Pain/Nausea/Vomiting 
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NRS Pain and PONV(0.01) 
This instrument will be used to assess for pain, nausea, and emesis. 
View 
no 
This instrument will be used to evaluate 3 symptom distress dimensions (frequency, severity, bothersomeness) for 
12 symptoms related to opioid used. 
View 
ORSDS Questionnaire 
yes 
ORSDS Questionnaire(0.01) 
PQRS Cognitive Domain 
PQRS Cognitive Domain(0.01) 
This instrument will be used to score cognitive performance. 
View 


yes 
Readiness for This Discharge Questionnaires 
instrument will be used to assess if patients are ready to be discharged from the PACU and subsequently, 
discharged to home. 
View TNS Questionnaire yes 
Readiness for yes 
Discharge Questionnaire(0.01) 
TNS Questionnaire(0.01) 
This determine neurological instrument if a symptoms patient will be has used (TNS). 
transient 
to 


1/18/2017 Print: 2016-0499 - Spinal versus General Anesthesia with Popliteal and Adductor Canal Blocks for Ambulatory Foot 
and Ankle Surgery. A Double-Blinded... 
ID: 2016-0499 Section: PART II - Clinical Research Proposal - Interventions or Observations 
H
elp Randomization 
1.0 Please state who will do the Randomization: 
Research staff who are not affiliated with the study will prepare opaque and sealed randomization treatment 
envelopes. 
2.0 Please state when the Randomization will be done: 
The randomization will be done before enrollment begins. 
3.0 Please state how the Randomization will be performed: 
Randomizer, an Excel-compatible randomizing program, will be used by non-study research personnel to assign 
treatments, using two treatment arms and a target enrollment of 18 patients per treatment arm. The non-study 
research personnel will then prepare opaque sealed treatment envelopes. 
4.0 Please state who will insure that the Randomization is carried out and if 
anyone will be blinded to the Randomization group: 
The primary investigator and co-investigators will ensure that randomization is carried out. The research assistants 
administering surveys/questionnaires and patients will be blinded. 
H
elp ID: 2016-0499 Section: PART II - Clinical Research Proposal - Sample Size & Data Analysis 
H
elp Sample Size and Data Analysis 
If you are uncertain about how to calculate your sample size and determine appropriate data 
analysis, please contact the Epidemiology and Biostatistics Core at biostats@hss.edu for 
assistance in completing this section. 
1.0 
Is this is a case series based only on the patients available using descriptive statistics in lieu of a 
sample size calculation? 
* No 
Help Help Sample Size and Data Analysis 
Support estimates with evidence from the literature of prior studies and perform an appropriate 
sample size calculation. 
For hypothesis testing (e.g., the calculation of p-values using statistical tests), you need to 
estimate your available sample size and calculate the effect size that will be detectable 
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and Ankle Surgery. A Double-Blinded... 
ID: using 2016-0499 your proposed Section: PART statistical II - Clinical analysis Research 
plan. Proposal This also - Sample applies Size to & a Data case Analysis series where you 
plan hypothesis testing. 
1.0 If you have consulted with a statistician, please indicate their 
name: Kara Fields 
2.0 Proposed sample size analysis, include the following: 
Student's t-test, ANOVA, chi-square, regression, etc; Alpha level; Beta or power level; Primary 
outcome variable estimate (mean +/-s.d. for continuous outcome, frequency/percentage for 
categorical variable); Number of groups being compared (use 1 for paired analysis within the 
same subjects); Effect size or change expected between groups; Resulting number per group 
1. Proposed analysis (e.g., student’s t­test, ANOVA, chi­square, 
regression, etc.): Two-sample t-test or Wilcoxon rank-sum test 2. Alpha level: 0.05 3. Beta or power level: 80% 
4. Primary outcome variable estimate (mean +/- s.d. for continuous 
outcome, frequency/percentage for categorical variable): Mean ± SD PACU length of stay = 132 ± 42 minutes (Luu 
– unpublished data) 5. Number of groups being compared (use 1 for paired analysis within 
the same subjects): 2 6. Effect size or change expected between groups: 45 minutes (Mulroy 
2000) 7. Resulting number per group: 16 8. Total sample size required: 32 + additional 10% to account for 
attrition = 
36 
References: 
Mulroy MF, Larkin KL, Hodgson PS, Helman JD, Pollock JE, Liu SS. A comparison of spinal, epidural, and general 
anesthesia for outpatient knee arthroscopy. Anesth Analg 2000; 91:860–4. 
3.0 
Data Analysis: describe how the primary outcome will be analyzed and what types of statistical 
calculations will be used. Do the same for each secondary outcome. Reiterate briefly the main 
analysis to be done, which groups, which variables, possible confounders. Address how possible 
confounders will be identified and handled in analysis: 
Balance on demographics and baseline characteristics will be assessed by calculating standardized differences 
(difference in means or proportions divided by the pooled standard deviation). Balance will be assessed using two 
thresholds: (1) 1.96 x (2/18) 
1/2 
= 0.653 and (2) 0.2 (Austin 2009). 
The primary outcome will be compared between groups using a two-sample t- test or Wilcoxon rank-sum test. 
Effect size will be presented as difference in 
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and Ankle Surgery. A Double-Blinded... 
ID: 2016-0499 means Section: or Wilcoxon-Mann-Whitney PART II - Clinical Research odds with Proposal 95% - 
confidence Sample Size interval. 
& Data Analysis Secondary outcomes with a single measurement per patients will be compared between groups 
using two­sample t­tests or Wilcoxon rank­sum tests for continuous and ordinal variables, respectively, and χ 
2 
or Fisher’s exact tests, as appropriate, for binary variables. 
Secondary outcomes measured multiple times per patient will be analyzed using the generalized estimating 
equations method with an identity link for continuous variables and logit link for binary variables. Effect sizes will 
be presented as difference in means, Wilcoxon- Mann-Whitney odds, or risk difference and relative risk with 95% 
confidence intervals. Analyses of secondary outcomes will be considered exploratory. 
The success of blinding of the patient and research assistant will be assessed using the Bang Blinding Index (Bang 
2010). 
All analyses will abide by the intention-to-treat principle. 
References: 
Austin PC. Balance diagnostics for comparing the distribution of baseline covariates between treatment groups in 
propensity-score matched samples. Stat Med 2009; 28: 3083-107. 
Bang H, Flaherty SP, Kolahi J, Park J. Blinding assessment in clinical trials: A review of statistical methods and a 
proposal of blinding assessment protocol. Clin Res Regul Aff 2010; 27:42-51 
Help Help Consent Information 
1.0 Describe how, when, and where the consent process will be 
initiated: 
Surgeon co-investigators will introduce the concept of the study to patients during a preoperative visit. Potential 
patients from the OR schedule will be identified by the research assistant on the day before surgery. Patients' records 
will be reviewed to determine eligibility. On the day of surgery, the research assistant will approach the patient 
about the study, and one of the anesthesiologist and/or surgeon co-investigators will review study details and obtain 
consent. 
2.0 Who will obtain informed consent from subjects for this 
research? First Name Middle Name Last Name Title Jacques YaDeau, MD, PhD IRB Vice Chair Scott Jacob Ellis, 
MD Foot and Ankle Surgeon Matthew Roberts, MD Vincent Lasala, MD Thuyvan Luu Leonardo Paroli, MD Kethy 
JulesElysee, MD Director of Pre-Anesthesia Screening David S. Levine, MD Richard Kahn, MD 
H
elp ID: 2016-0499 Section: PART III - IRB Application - Submission Summary 
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H
elp IRB Application 
1.0 Please provide lay abstract: 
The purpose of this study is to determine if there is a difference in patient outcomes with general versus spinal 
anesthesia when given in addition to popliteal and adductor canal nerve blocks for foot and ankle surgery. Popliteal 
and adductor canal nerve blocks are injections of local anesthetic agents near nerves in the back and front of the 
knee going to the foot and ankle that provide numbness during and after surgery. These peripheral nerve blocks offer 
good pain control and reduce the need for opioids (opioids are pain medications such as morphine, Dilaudid, and 
oxycodone). General anesthesia involves the flow of oxygen and anesthesia gas through a tube which, along with 
additional intravenous medications, causes unconsciousness and unawareness of sensations during surgery. Spinal 
anesthesia involves an injection of local anesthetic in the lower back, which causes numbness below the waist. In 
addition to spinal anesthesia, a sedative is typically given intravenously to cause relaxation and sleepiness 
throughout surgery. 
General, spinal, and nerve block anesthesia are all routinely used for surgery at the Hospital for Special Surgery. 
General or spinal anesthesia is typically used in addition to peripheral nerve blocks during foot and ankle surgery to 
1) allow the surgeons to use a thigh tourniquet to reduce bleeding, 2) provide anesthesia earlier, and 3) prevent 
unwanted movement. However, it is unclear whether general or spinal anesthesia provides better patient outcomes 
when given with peripheral nerve blocks. Some reports show that on its own, spinal anesthesia has advantages over 
general anesthesia in terms of side effects such as nausea and pain. However, these advantages may also be gained 
from combining peripheral nerve blocks with general anesthesia. Spinal anesthesia can be associated with headache 
and backache, although headache and backache can also happen after operations performed with general anesthesia. 
A previous study at the Hospital for Special Surgery showed low rates of nausea among patients who received nerve 
blocks with spinal anesthesia, and no nausea among patients who received a nerve block with general anesthesia. 
Therefore, the primary aim of this study is to determine if, as a treatment, either general or spinal anesthesia has 
advantages over the other treatment in terms of side effects, pain, patient satisfaction, and time it takes to leave the 
hospital in an ambulatory foot and ankle population. 
2.0 * Requested Review Type: 
Full IRB Review 
3.0 Ancillary/Impacted Services Review (select all that apply): 
Note: Do not confuse the committees below with CRP or Research Service Chief Ancillary 
Committees Nursing 
4.0 * Is Genetic Testing involved in this study? No 
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H
elp Assessment of Research Procedures 
1.0 Describe any potential for direct benefits to participants in this 
study: 
Due to the nature of this study, which is comparing two standard of care treatments, patients may not receive any 
direct benefit from participating. However, patients who receive general anesthesia with peripheral nerve blocks 
might meet discharge criteria earlier after surgery because their discharge will not be delayed by the time it takes for 
spinal anesthesia to resolve. Therefore, patients who receive general anesthesia may be released to the comfort of 
their own home earlier than patients who receive spinal anesthesia. 
2.0 Describe any potential benefits to society: 
This study would increase our understanding of whether general or spinal anesthesia provides better patient 
outcomes when given with peripheral nerve blocks. Previous studies that have compared general and spinal 
anesthesia without peripheral nerve blocks have shown that spinal anesthesia leads to lower rates of nausea and 
opioid use. However, these advantages may also be gained from combining peripheral nerve blocks with general 
anesthesia, so this study will help determine how general anesthesia compares to spinal anesthesia in terms of 
patient outcomes when used in conjunction with peripheral nerve blocks. 
H
elp Greater Than Minimal Risk - Radiographs/CT/MRI Test 
1.0 Describe potential non-radiographic risks of the research study and assess their likelihood 
and seriousness. 
The popliteal and adductor canal nerve blocks are very commonly performed at HSS for foot and ankle surgery 
under ultrasound guidance. There is a chance that the nerve may become irritated or injured during the injection; 
however, the risk is very small. Ultrasound is safe and involves no ionizing radiation. 
General anesthesia and spinal anesthesia are both commonly used at HSS, as well as other hospitals, and are 
considered safe and effective. It is not clear whether spinal or general anesthesia is safer for patients such as 
yourself. There are potential rare serious complications from both types of anesthesia. Potential rare risks of general 
anesthesia include problems with the heart, lungs, and cognition (thinking) after surgery. These complications may 
be more likely with older patients. Potential rare risks of spinal anesthesia include spinal cord injury. Older patients 
are more likely to have conditions that increase the risk of spinal cord injury. Most patients having spinal anesthesia 
for foot and ankle surgery receive intravenous sedation, so that they are ‘asleep’ during surgery. Sedation has 
potential rare serious complications such as problems with the lungs and cognition (thinking) after surgery. 
There are less serious potential risks from general anesthesia and spinal anesthesia. It is possible that patients 
receiving general anesthesia will be more likely to have a sore throat from the tube used to keep the airway open (a 
laryngeal mask airway will be used if possible). Some studies suggest that nausea and vomiting are more likely with 
general anesthesia (but a recent study at HSS showed no nausea after general anesthesia). It is possible to have a 
headache or backache after spinal anesthesia, but most headaches and backaches after surgery are not from the 
anesthetic. If you experience prolonged numbness from the spinal, this may cause a longer stay in the hospital, but 
this possible delay is in terms of hours. We will attempt to avoid prolonged numbness from the spinal by choosing 
an appropriate amount of local anesthetic. 
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Participation in this research involves the potential risk of a breach of confidentiality to your stored health 
information. HSS tries to minimize those risks by (i) removing some direct identifiers from stored information (i.e., 
names, social security numbers, medical record numbers); (ii) securing, in a separate location, and limiting access to 
information that would identify you; and (iii) limiting access to information stored to HSS investigators. 
2.0 
If radiographs/CT/MRI are included in the research study, please selected the applicable tests 
with standard wording for risks from the list below: 
Please contact Roseann Zeldin (212- 
Name Risk Description 
Ultrasound is an extremely safe procedure with no known untoward Ultrasound 
effect using diagnostic frequencies. Ultrasound involves no ionizing radiation. 
606-1025) for specific exposure values for all radiographs sought. 
Help 
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H
elp Greater Than Minimal Risk 
1.0 
Describe measures that will be used to minimize physical risks. Where appropriate, discuss 
provisions for insuring medical and professional intervention in the event of adverse effects to 
the subject. For example, what precautions are in place to prevent and/or treat potential physical 
risks which may arise from research related procedures (i.e. infections, DVTs, etc...). 
All medical procedures involved in the study are standard of care. All patients will undergo routine monitoring 
before, during, and after surgery, and information regarding any post-discharge complications will be provided by 
the clinical team. 
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Please contact Roseann Zeldin (212- 606-1025) for specific exposure values for all radiographs 
sought. 
2.0 Discuss why the risks to the subjects are reasonable in 
relation to the anticipated benefits and the importance of knowledge that may be expected to 
result. State to which patients your study results should apply. If you get a result, what will be its 
significance to physicians and their patients? 
Both general and spinal anesthesia are standard of care treatments and patients would receive one of these treatments 
regardless of whether they participate in the study or not. The benefit of understanding whether general or spinal 
anesthesia provides better patient outcomes when given with peripheral nerve blocks will be important to physicians 
and their patients. Physicians will be able to recommend the more advantageous treatment for their patients and 
perhaps the stigma behind general anesthesia will be reduced. 
3.0 Describe any alternative treatments and procedures that 
might be advantageous to the subjects: 
Patients will receive either general or spinal anesthesia with peripheral nerve blocks, regardless of whether they 
participate in the study or not, but they will not know which treatment they receive if they choose to participate. The 
alternative is choosing whether to receive general or spinal anesthesia with peripheral nerve blocks. 
H
elp ID: 2016-0499 Section: PART III - IRB Application - Assessment Procedures 


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and Ankle Surgery. A Double-Blinded... 
H
elp Informed Consent 
1.0 Indicate the types of consent that will be involved in this study 
(check any or all that apply): Informed Consent Category Written/signed consent by subject 
2.0 Waivers: If you are applying for any waivers of consent (check 
any or all that apply): 
Name Waiver of Consent 
Waiver of Assent 
Waiver of Parental Permission Waiver of Written or Signed Consent (i.e. information sheets, telephone consent, 
verbal script) 
3.0 * Will this study include non-english speaking participants? 
No 
4.0 If the study does not include non-english speaking 
participants, please justify: 
While some surveys we are using are validated in English, not all of the surveys are. Therefore, we cannot include 
non-English speaking participants. 
5.0 
Please provide assurance by checking the box below that the study will make all possible efforts 
to collect Federally mandated gender, race and ethnicity data for all subjects included in the 
study. 
Agree 
This will not be possible for the following reasons: 
6.0 Will this study be posted at ClinicalTrials.gov? 
Yes No 
If yes, please post at the site upon approval of the study by the IRB. ClinicalTrials.gov requires that listings be 
updated every 12 months as well as 30 days after Major Amendment approvals of a protocol. For more information 
about what studies should be posted at the site and when to update a posted study at the site, please visit the 
following website: http://www.icmje.org/faq_clinical.html 
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H
elp Consent Forms & Process of Consent 
1.0 
Good News! We've prepared several different types of consent form templates with some of the 
information you have already provided. Please follow the instructions below to complete the 
process. 
Lay term Glossary Instructions: 1.1) Download the applicable consent form(s) to your machine 
and modify as appropriate. Save the modified documents and upload them in the following 
question. 
Informed Consent To Participate In Research Registry 
1.2) Please upload all informed consents, waivers, translated documents, phone recruitment 
scripts, recruitment ads, brochures, etc to be used in this study. Name Modified Version 
Patient Information- LMA vs Spinal 12_1_16.docx 
12/1/2016 PM 
H
elp Data Privacy & Confidentiality 
1.0 How will the data for this study be collected and recorded? 
Data will be collected via patient interviews (in person at hospital and over the phone postoperatively) and medical 
records. All data will be recorded in password- protected REDCap and medication usage (Excel) databases. Study 
files will be maintained in an encrypted folder on a shared drive. 
2.0 Select Data Recording Identifiers used on this study: 
Name De-identified Coded (Data will be linked to subjects via encrypted codes) Limited Data Set Identifiable 
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2:21 
0.01 
C1 Ya Deau 2016-0499 Informed consent (revised 12-01- 16).docx 
12/1/2016 PM 
2:14 
0.03 
YaDeau LMA vs Spinal FA Informed Consent Form 
11/4/2016 AM 
9:21 
0.02 


Assent Form For Adolescent Participation In Research Study 
Informed Consent To Participate In A Genetic Research Study 
Informed Consent To Participate In Research 


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2.1 If Other is selected, please specify: 
Data will be stored in a password-protected REDCap database. Data will be entered by research personnel on a 
password-protected computer or tablet. Subject privacy and confidentiality will be maintained through the storage of 
study data in a password-protected computer database maintained by the research staff and accessible only to the 
principal investigator (Dr. YaDeau), in addition to other IRB-approved study personnel. Each subject will be 
assigned a unique study number for identification in the study database. This unique study number will not be 
derived from or related to information about the individual. 
3.0 Where will the research data be stored? Please specify the 
physical location and how it will be secured to protect confidentiality: 
Research administrators and auditors within our research group will have access to the study records and data. This 
is required for regulatory maintenance. These individuals include Denesy Mancenido (Clinical Research Manager, 
HSS) and Jodie Curren (Auditor; Clinical Research Supervisor, HSS). At the time of data analysis, the biostatistician 
(Kara Fields, HSS) will have access to the limited dataset. 
4.0 Who, other than the specified study team, will have access to 
the study records or data? Specify their name, role, and affiliation. 
Data will be released to the project's statistician at the end of the study. Any identifiers not essential for data analysis 
will be removed from the data set, which will be sent to the statistician as a password-protected, encrypted file. 
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Do not list study personnel already listed in Section 1: 
5.0 If coded or identified data will be released, specify the 
persons/agencies to whom the information will be released. Please also indicate the provisions 
that will be taken to assure that the transmission of the data will maintain confidentiality: 
The study will undergo data analysis by a statistician upon completion, and the data set will be stored as an Excel or 
SPSS file. A unique feature of REDCap is that data fields marked as protected health information can be 
automatically de- identified when data is exported. We will utilize this option when closing out the study after data 
analysis, so that limited identifiers remain in the stored Excel or SPSS data set. In the REDCap program, the study 
will be changed from production mode to archive mode. This means the data and study forms will no longer be 
accessible to REDCap users. Only the research assistant and research manager will have rights to un-archive the 
study. The study will be maintained in REDCap for the period of time required by hospital/federal regulations, at 
which point it will be deleted. 
6.0 Describe what will happen to the data or data set when the 
study is completed. Please indicate your plans for the destruction of identifiers at the earliest 
opportunity consistent with the conduct of the research and/or clinical needs, if applicable: 
Audio/video recordings and photographs will not be used. 
7.0 


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If audio/video recordings or photographs will be used, specify your plans for deidentifying or 
anonymizing the material and when it will be destroyed: 
Audio/video recordings and photographs will not be used. 
8.0 Describe the data management software that will be used. 
Identify who will enter the data, and what data quality control measures will be used, such as 
dual entry, validation checks and locked fields. Insure that your plans are consistent with HIPAA 
regulations. Contact Ms. Andrea Ansorge with any questions related to HIPAA regulations and 
research. 
Data will be entered into REDCap, which is a password-protected database hosted at HSS. Study personnel will 
enter the data, and routine audits will be performed to ensure quality. 
9.0 
Describe the measures that will be used to preserve confidentiality and rights of subjects. 
Below is Hospital for Special Surgery standard accepted practice. By completing this 
information, you attest that you will follow this procedure for preserving the confidentiality and 
rights of the subject. You can use the following standard, approved statement. 
Subject privacy and confidentiality will be maintained through the storage of study data in a password-protected 
computer database maintained by Dr. YaDeau and accessible only to the principal investigator (Dr. YaDeau), in 
addition to other IRB- approved study personnel. Each subject will be assigned a unique study number for 
identification in the study database. This unique study number will not be derived from or related to information 
about the individual. The key linking this unique study number to patient identifiers (i.e. name, medical record 
number, date of birth, registry number) will be maintained in a different password-protected database maintained by 
Dr. YaDeau, to which only Dr. YaDeau and Dr. YaDeau will have access. Immediately following data entry into the 
password-protected databases, the paper-based data collection instruments will be stripped of all personal identifiers 
and stored in a locked file cabinet maintained by Dr. YaDeau. The page containing patient identifiers will be stored 
separately in a locked file cabinet in the Anesthesiology Research Office, and will be destroyed at the earliest 
opportunity upon completion of the study. Presentations and publications that result from this study will NOT 
contain any individual identifiers other than unique study numbers. 
9.1 If the HSS statement does not apply, please revise it accordingly. 
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H
elp Certificate of Confidentiality 
Certificates of Confidentiality constitute an important tool to protect the privacy of research study participants. They 
are issued by the National Institutes of Health (NIH) to protect identifiable research information from forced 
disclosure. They allow the investigator and others who have access to research records to refuse to disclose 
identifying information on research participants in any civil, criminal, administrative, legislative or other 
proceeding, whether at the federal, state or local level. 
Certificates of Confidentiality may be granted for studies collecting information that, if disclosed, could have 
adverse consequences for subjects or damage their financial standing, employability, insurability, or reputation. By 
protecting researchers and institutions from being compelled to disclose information that would identify research 
subjects, Certificates of Confidentiality help achieve the research objectives and promote participation in studies by 
assuring confidentiality and privacy to participants. 
For more information, go to the following website: 
http://grants.nih.gov/grants/policy/coc/index.htm 
1.0 * Will a Certificate of Confidentiality be obtained for this study? 
No 
Help 
H
elp HIPAA 
The Healthcare Insurance Portability and Accountability Act (HIPAA) prohibits the use of a 
person's Protected Health Information without a valid authorization. 
1.0 * Will this study record any information which can identify the 
participants of this study? Yes 
2.0 * Will this study record information that if released, could 
reasonably place participants at risk of criminal or civil law suits? No 
3.0 * Will this study obtain or review information related to the 
respondent's medical records or health? Yes 
4.0 
Select the option(s) which fits this study: Name Self reported medical information Direct authorization through 
consent form Waiver of authorization requested (Full / Partial / Alteration) 
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HIPAA Waiver Flow Chart 
H
elp Waiver of HIPAA Authorization 


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and Ankle Surgery. A Double-Blinded... 
Pursuant to the Privacy Regulations of HIPAA, an IRB is only permitted to approve a waiver of 
individual subjects' authorization if it finds and documents specific criteria relevant to the 
protection of subject privacy. 
1.0 
I am seeking: 
A full waiver of subject authorization to use and disclose health information during the 
course of the research study. 
A partial waiver of subject authorization to use and disclose health information only for the 
purpose of: 
screening potential patients for study eligibility. We will need to review potential patients' 
medical records to determine whether they are eligible for the study. 
The following alteration to the authorization requirements: 
2.0 * Who will have access to the health information needed for the study? Please identify each 
person by name or category. Example include: the investigator, the research staff, co- 
investigators and their research staffs, and all research monitors. 
All members of the study team will have access to the health information for the study. In addition, the auditors in 
our research group will have access. Research administrators will also have access. 
3.0 * Please describe the risks to privacy presented by the 
research and whether the research presents more than minimal risk of harm to subjects' privacy. 
Include a description of what identifiers will be reviewed, collected, and stored; who will have 
access to identified information; how access to study data is controlled; who will monitor access 
to study data; and where data will be stored: 
Subject data will be maintained in a password-protected database (REDCap). Aside from auditors, non-study 
personnel will not have access to the data. In addition, the database will be assessed using a password-protected 
computer or iPad. Medication data will be kept in a password-protected folder. Measures will be taken to maintain 
subject privacy. Each subject will be assigned a unique study number of identification in the database. For screening 
purposes, preop medical records and history will be reviewed for each subject. No information will be collected until 
the subject is deemed eligible, and written informed consent is obtained. The following patient identifiers will be 
collected: name, MRN ID, date of surgery, and telephone numbers. Other data will be collected via medical chart 
review (medications) and patient interactions (in person or phone calls). Upon study completion, a statistician will 
receive a data set with all possible identifiers removed, and these study files will be de-identified and archived once 
accepted for publication. 
4.0 
* Can the research be practicably carried out without the waiver? Yes No 
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If it is impracticable to obtain individual authorization, please describe why: 
A partial waiver is needed, as non-treating providers will be accessing health information (e.g., research assistant, 
research associate) for screening and follow- up purposes. 
5.0 
* Can the research be practicably carried out without access to and use of identified health 
information? Yes No 
If it is impracticable to conduct this research without access to identified health information, 
please describe why: 
Names and telephone numbers are needed for postoperative follow-ups. MRN IDs are needed to look up patients' 
medical records. Therefore, access to identified health information is essential. 
6.0 * What is your plan to protect identifiers from improper use 
and disclosure? 
No identifiers will be included in any presentations or publications that result from this study. Only the listed 
investigators will have access to this information. Any patient information will be kept locked and secure. 
7.0 
* Will the patient identifiers be destroyed at the earliest opportunity? Yes No 
If yes, describe the plan for destroying identifiers (e.g. how, by whom, and when identifiers will 
be destroyed): 
Each subject will be assigned a unique study number that will not be derived from or related to identifiers. 
Immediately following data entry into the password- protected databases, any paper-based data collection 
instruments will be stripped of all personal identifiers by the research assistant and stored in a locked file cabinet 
maintained by the principal investigator. The page containing patient identifiers will be stored separately in a locked 
file cabinet in the Anesthesiology Research Department, and it will be destroyed at the earliest opportunity upon 
completion of the study. 
If no, indicate the health or research justification for retaining the identifiers: 
8.0 * Explain how PHI will be acquired and used: 
PHI will be acquired by the research assistants or investigators throughout the hospital stay. Demographic and 
medication information will b obtained from medical records. Study outcome-related data will be collected via 
patient interactions, either in person (day of surgery) or by phone (postoperative day 1). Data will be recorded and 
managed using REDCap electronic data capture tools hosted at the Clinical and Translational Science Center at 
Weill Cornell Medical College. Connection to REDCap occurs via the hospital's encrypted cable and wireless 
networks, and data will be entered through a password-protected computer or iPad. Medication usage will be 
recorded in Excel, and the file will be kept in a password-protected folder on a private drive. 
9.0 
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Explain how PHI will be protected during this study: 
Subject privacy and confidentiality will be maintained through the storage of study data in a 
password-protected computer database maintained by the PI and accessible only to the principal 
investigator, in addition to other IRB approved study personnel. Each subject will be assigned a 
unique study number for identification in the study database. This unique study number will not 
be derived from or related to information about the individual. The key linking this unique study 
number to patient identifiers (i.e. name, medical record number, date of birth, registry number, 
etc...) will be maintained in a different password protected database maintained by to which only 
will have access. 
Subject privacy and confidentiality will be maintained through the storage of study data in a password-protected 
REDCap database maintained by the PI, Dr. Jacques YaDeau, and accessible only to the principal investigator and 
other IRB-approved study personnel. Each subject will be assigned a unique study number for identification in the 
study database. This unique study number will not be derived from or related to information about the individual and 
is autogenerated on REDCap. Data, including paper-based data collection instruments that are stripped of all 
personal identifiers, will also be stored in folders located in a locked cabinet in the Anesthesiology Research Office. 
10.0 * Justify your need to collect PHI on this study: 
PHI will be need to look up preop and periop information in medical charts. It will also be needed for postop phone 
follow-ups. 
Help 
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H
elp PHI Identifiers 
1.0 
Identify the types of PHI collected: 
Name Questionnaires or Interviews 
Billing Information or Databases 
Mental Health Records 
Data Registry 
Hospital or Medical Records 
Biological Samples 
DNA Samples 
Other 
1.1 If Other, please specify the type of PHI collected: 
2.0 
Select all the PHI Identifiers that apply: Identifiers Names Telephone Numbers Medical Record numbers Any other 
unique identifying numbers, characteristics, or code 
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H
elp Data Safety Monitoring Plan 
1.0 * Check the one box below that most accurately reflects the 
plan for data and safety monitoring for this study. The study will be monitored only by the study investigators and/or 
sponsor. 
1.1 If Other, Please specify your plan for data safety and monitoring for the study. If no DSMB 
required, Please specify why: 
2.0 Describe the clinical criteria for withdrawing an individual subject from the study due to 
safety or toxicity concerns: 
Subjects will be kept overnight at HSS for monitoring and treatment if they develop complications and do not meet 
the criteria for discharge on the day of surgery. 
3.0 Summarize any pre-specified criteria for stopping or changing 
the study protocol due to safety concerns. 
General and spinal anesthesia have both been proven to be safe and effective, but if new information arises that 
either is considered unsafe at any point, immediate changes will be made to the protocol and informed consent form. 
4.0 * Are there any plans to perform an interim efficacy analysis: 
No 
4.1 If you answered Yes, please describe the plans to conduct an interim analysis. 
H
elp Final Page 
You have completed your application! 
Please hit "Continue" to finish the HSS Clinical Trial Form. 
Please note that a submission may only be forwarded to the IRB by the Principal Investigator. To do this, the 
Principal Investigator must press the "SUBMIT STUDY" button in My Activities for this Study ID:2016-0499. 
You can track the ongoing status of your submission by logging into the study workspace. 
Please feel free to contact the IRB with any questions or concerns. 
ID: 2016-0499 Section: HSS Clinical Trial Registry 
H
elp HSS Clinical Trial 
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The ID: 2016-0499 Clinical Trial Registry Section: is posted HSS on Clinical the Trial HSS 
Registry main page to highlight research (including retrospective studies) being conducted at 
HSS. This same language, once approved by the IRB, can then be used on flyers if you so choose, 
to post in an effort to recruit subjects. 
1.0 Title: Spinal versus General Anesthesia with Popliteal and Adductor Canal Blocks 
for Ambulatory Foot and Ankle Surgery. A Double-Blinded Randomized Controlled Trial. 
2.0 PI: Jacques YaDeau, MD, PhD 
3.0 Co-Investigators: 
First Name Middle Name Last Name Title Angie Zhang Research Assistant Scott Jacob Ellis, MD Foot and Ankle 
Surgeon Matthew Roberts, MD Kara Fields Volunteer Vincent Lasala, MD Jodie Curren, RN Seong Jin Kim Senior 
Research Assistant Leonardo Paroli, MD Phuong Dinh Mac Kethy JulesElysee, MD Director of Pre-Anesthesia 
Screening George Birch David S. Levine, MD Richard Kahn, MD 
4.0 
Posting date: Name Upon IRB approval 
Post on this date: 
5.0 
Condition: Foot and Ankle Conditions 
Other: 
6.0 State the summary including number of patients, enrollment 
period and duration of follow-up (use lay terms): 
This study is looking at ambulatory foot and ankle surgery patients to determine if they experience a difference in 
their recovery after receiving popliteal and adductor canal nerve blocks with either general anesthesia or spinal 
anesthesia. Popliteal and adductor canal nerve blocks are injections of local anesthetic agents near nerves in the back 
and front of the knee going to the foot and ankle that provide numbness during and after surgery. These peripheral 
nerve blocks offer good pain control and reduce the need for opioids (opioids are pain medications such as 
morphine, Dilaudid, and oxycodone). General anesthesia involves the flow of oxygen and anesthesia gas through a 
tube which, along with additional intravenous medications, causes unconsciousness and unawareness of sensations 
during 
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and Ankle Surgery. A Double-Blinded... 
ID: 2016-0499 surgery. Spinal anesthesia Section: involves HSS an Clinical injection Trial of Registry local 
anesthetic in the lower 
back, which causes numbness below the waist. In addition to spinal anesthesia, a sedative is typically given 
intravenously to cause relaxation and sleepiness throughout surgery. 
General, spinal, and nerve block anesthesia are all routinely used for surgery at the Hospital for Special Surgery. 
General or spinal anesthesia is typically used in addition to peripheral nerve blocks during foot and ankle surgery to 
1) allow the surgeons to use a thigh tourniquet to reduce bleeding, 2) provide anesthesia earlier, and 3) prevent 
unwanted movement. However, it is unclear whether general or spinal anesthesia provides better patient outcomes 
when given with peripheral nerve blocks. Some reports show that on its own, spinal anesthesia has advantages over 
general anesthesia in terms of side effects such as nausea and pain. However, these advantages may also be gained 
from combining peripheral nerve blocks with general anesthesia. Spinal anesthesia can be associated with headache 
and backache, although headache and backache can also happen after operations performed with general anesthesia. 
A previous study at the Hospital for Special Surgery showed low rates of nausea among patients who received nerve 
blocks with spinal anesthesia, and no nausea among patients who received a nerve block with general anesthesia. 
Therefore, the primary aim of this study is to determine if, as a treatment, either general or spinal anesthesia has 
advantages over the other treatment in terms of side effects, pain, patient satisfaction, and time it takes to leave the 
hospital in an ambulatory foot and ankle population. To do this, 36 patients will be randomly assigned to receive, 
along with popliteal and adductor canal blocks, either general anesthesia or spinal anesthesia. In the recovery room 
after surgery, patients will be assessed every 15 minutes for readiness for discharge. Other postoperative 
assessments (pain, nausea, cognitive ability, backache, headache, sore throat, discomfort, opioid-related side effects 
and satisfaction) will be made in the recovery room and via phone on POD 1. 
7.0 State the inclusion and exclusion criteria (use lay terms): 
Inclusion criteria 
18-75 aged patients ASA1-3 Elective foot and ankle day surgery procedures, lasting between 1 and 3 hours as per 
surgeon, performed by 3 co-investigator surgeons Capable of providing informed consent in English Planned for 
combined popliteal and adductor canal block No contraindications for spinal or LMA general anesthesia 
Exclusion criteria 
Incapable of providing informed consent, Contraindications for regional or LMA anesthesia (anticoagulation, 
infection at injection site) Cnticipated difficult airway, BMI>40, Anticipated surgical procedure time less than 1 
hour or more than 3 hours, Hx of severe PONV ASA >3, Peripheral neuropathy affecting the operative extremity 
Pregnant or nursing women, Chronic opioid use (daily use of opioids one month prior to surgery/ patients requiring 
chronic pain interventions) Prone position OSA with planned admission overnight to the hospital Known 
allergy/sensitivity to any study medications Planned admission after surgery 
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ID: 8.0 2016-0499 State the contact information Section: HSS Clinical for the Trial study: 
Registry PI: Jacques YaDeau, 212-606-1206, yadeauj@hss.edu 
Study coordinator: Thuyvan Luu, 646-797-8975, luut@hss.edu 
Help 
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ICF_000.pdf: 
 
Form 10 - ICF Document (Template Version 2/14/13) 
 
 
 
 
 
 
Page 1 of 12 
 
IRB Administrative Use Only 
 
Hospital for Special Surgery Institutional 
Review Board Approval 
12/19/2016 Thru 11/21/2017 
HOSPITAL FOR SPECIAL SURGERY 
535 East 70th Street  
New York, NY 10021 
 
 
INFORMED CONSENT TO PARTICIPATE IN RESEARCH 
 
TITLE: Spinal Versus General Anesthesia with Popliteal and Adductor Canal Blocks for 
Ambulatory Foot and Ankle Surgery. A Double-Blinded Randomized Controlled Trial. 
 
PROTOCOL NO.: 2016-0499 
 
SPONSOR: Department of Anesthesiology 
 
INVESTIGATOR: Jacques YaDeau, MD 
 
SITE(S): Hospital for Special Surgery 
 
STUDY-RELATED PHONE NUMBER(S): Dr. Jacques YaDeau, (212) 606-1206 
 
IRB #: 2016-0499 
 
You are being asked to take part in a research study conducted by Hospital for Special Surgery 
(HSS).  You are being asked to participate in this study because you are undergoing ambulatory 
foot and ankle surgery with Dr. Ellis, Levine or Roberts, and your surgeon thinks that nerve 
blocks for pain relief after surgery are a good idea for you. 
 
You will still be responsible for the cost of your medical care just as you would be if you 
were not part of this study.  For example, any co-pays, deductibles, and co-insurance 
associated with your medical care. 
 
This document provides you with information about this study.  After reading this document, any 
questions you may have will be answered.  You may take as much time as you need to review 
this document and ask questions to consider participating in this study before your surgery today.  
 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by 
U.S. Law. This Web site will not include information that can identify you. At most, the Web site 
will include a summary of the results. You can search this Web site at any time. 
  
 
1.  WHY IS THIS STUDY BEING DONE? 
 
The purpose of this study is to determine if there is a difference in patient outcomes with general 
versus spinal anesthesia when given in addition to the popliteal and adductor canal nerve blocks 
you will receive for your surgery today. Popliteal and adductor canal nerve blocks are injections 


 
Form 10 - ICF Document (Template Version 2/14/13) 
 
 
 
 
 
 
Page 2 of 12 
 
IRB Administrative Use Only 
 
Hospital for Special Surgery Institutional 
Review Board Approval 
12/19/2016 Thru 11/21/2017 
of local anesthetic agents near nerves in the back and front of the knee going to the foot and 
ankle that provide numbness during and after surgery. These peripheral nerve blocks offer good 
pain control and reduce the need for opioids (opioids are pain medications such as morphine, 
Dilaudid, and oxycodone). General anesthesia involves the flow of oxygen and anesthesia gas 
through a tube which, along with additional intravenous medications, causes unconsciousness 
and unawareness of sensations during surgery. Spinal anesthesia involves an injection of local 
anesthetic in the lower back, which causes numbness below the waist. In addition to spinal 
anesthesia, a sedative is typically given intravenously to cause relaxation and sleepiness 
throughout surgery.  
 
General, spinal, and nerve block anesthesia are all routinely used for surgery at the Hospital for 
Special Surgery. General or spinal anesthesia is typically used in addition to peripheral nerve 
blocks during foot and ankle surgery to 1) allow the surgeons to use a thigh tourniquet to reduce 
bleeding, 2) provide anesthesia earlier, and 3) prevent unwanted movement. However, it is 
unclear whether general or spinal anesthesia provides better patient outcomes when given with 
peripheral nerve blocks. Some reports show that on its own, spinal anesthesia has advantages 
over general anesthesia in terms of side effects such as nausea and pain. However, these 
advantages may also be gained from combining peripheral nerve blocks with general anesthesia. 
A previous study at the Hospital for Special Surgery showed low rates of nausea among patients 
who received nerve blocks with spinal anesthesia, and no nausea among patients who received a 
nerve block with general anesthesia. Therefore, the primary aim of this study is to determine if, 
as a treatment, either general or spinal anesthesia has advantages over the other treatment in 
terms of side effects, pain, patient satisfaction, and time it takes to leave the hospital in an 
ambulatory foot and ankle population. 
 
 
2.  WHAT WILL YOUR PARTICIPATION REQUIRE?   
 
Participation in this study will not involve any additional visits to the hospital. If you decide to 
be in this study, the following routine and/or study-related procedures will be performed:  
 
Study Visit # 
Surveys / 
Questionnaires 
Randomization Surgery 
Phone 
Contacts 
#1 – Holding area, before 
surgery 
X 
X 
SOC 
 
#2 – In recovery room, 
every 15 minutes until 
discharge 
X 
 
 
 
#3 – In recovery room, 1 
hour after surgery 
X 
 
 
 
#4 – In recovery room, 2 
hours after surgery 
X 
 
 
 
#5 – Postoperative Day 1 
X 
 
 
X 
#6 - Anesthesiologist 
Follow-Up (if needed) 
 
 
 
X 


 
Form 10 - ICF Document (Template Version 2/14/13) 
 
 
 
 
 
 
Page 3 of 12 
 
IRB Administrative Use Only 
 
Hospital for Special Surgery Institutional 
Review Board Approval 
12/19/2016 Thru 11/21/2017 
 
X=  Research procedures 
SOC= Standard of care (care you would receive if you were not participating in this study) 
 
Before surgery 
 
In the holding area, you will be asked a series of questions to rate how you are feeling and assess 
your cognitive function (ability to perform tasks with your brain). You will be asked about your 
medication usage and history of headache/backache symptoms. An alcohol swab will be applied 
to both sides of your lower leg and between your first and second toes to check nerve function. A 
brief review of your medical chart will be conducted to collect basic information, such as age, 
sex, height, and weight. 
 
During surgery 
 
All patients will receive popliteal and adductor canal blocks, but the study will select the rest of 
your anesthetic treatment randomly.  You will be assigned by chance to receive either general 
anesthesia or spinal anesthesia. The randomization process is comparable to (or similar to) the 
flip of a coin.   
 
You have a 50% chance of receiving either of the following treatments: 
1. Popliteal and adductor canal nerve blocks with standard of care general anesthesia 
2. 
Popliteal and adductor canal nerve blocks with standard of care spinal anesthesia 
and sedation 
 
If you have a preference for one of the treatments and would like to be sure to receive that 
treatment, you should not be enrolled in the study. 
 
In order to fairly evaluate the two treatments, both you and the study personnel assessing you 
will be blinded as to which anesthetic you were given. This means you will not be told whether 
you received general or spinal anesthesia. If you are interested, we can contact you with the 
results and your treatment information when the study ends.   
 
Please note that you will also receive other anesthetic drugs intravenously throughout the 
surgical procedure. These drugs will be the same regardless of whether you receive general or 
spinal anesthesia. During surgery, medications will be given to reduce the chance of nausea after 
the surgery. 
 
After surgery 
 
Once you are in the recovery room and your surgery is over, a study team member who does not 
know which treatment you received will assess your condition every 15 minutes to follow your 
rate of recovery. When you awake from general anesthesia or the spinal anesthesia wears off, the 
alcohol swab test will be applied again to test block function (by seeing if the nerve blocks made 
parts of the operative foot numb). After one and two hours in the recovery room, you will be 


 
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IRB Administrative Use Only 
 
Hospital for Special Surgery Institutional 
Review Board Approval 
12/19/2016 Thru 11/21/2017 
asked a series of questions to rate how you are feeling and assess your cognitive function. When 
you are ready to be discharged, we will ask some additional questions about your experience, 
satisfaction and which treatment you think you received. We will provide you with a Patient 
Information Sheet with information regarding the next day’s follow-up. 
 
Day after surgery 
 
On the day after your surgery, you will be contacted by phone by a study team member and 
asked about how you are feeling, your cognitive function, any side effects that you may have 
experienced, and your overall satisfaction with your care. If it is determined that you may have 
had any symptoms of concern, you will be contacted by an anesthesiologist for follow-up. 
 
Overall, your participation will occur over the course of your stay in the hospital and the day 
after. It may involve up to 6 study contacts, including the assessment of your condition every 15 
minutes in the recovery room and any follow-ups deemed necessary by an anesthesiologist. The 
repeated assessment every 15 minutes is expected to last 1-2 minutes, and all other contacts are 
expected to last 10-15 minutes.  
 
You and/or your insurance will be responsible for any costs of all procedures performed that are 
standard of care, that is, care that you would receive even if you were not in this study. 
 
A total of 36 subjects will participate in this study at HSS.   
 
 
3.  WHAT ADVERSE (BAD) EFFECTS CAN HAPPEN FROM BEING IN THE STUDY?  
WHAT RISKS ARE KNOWN ABOUT THE STUDY DRUG/STUDY DEVICE? 
 
All treatments applied to you as a participant in this study are standard of care. The risks from 
participation in this study and receiving the peripheral nerve blocks for pain relief after the 
surgery are the same risks you would face with your surgical anesthesia if you did not participate 
in this study. These risks will be discussed in detail with you by your anesthesiologist and are 
described below.  
 
 In addition to the nerve blocks, you need either a general anesthetic or a spinal anesthetic. The 
study involves randomly assigning you to receive either spinal or general anesthesia. Both spinal 
and general anesthesia are commonly used at HSS, as well as at other hospitals. Both spinal and 
general anesthesia are considered safe and effective. It is not clear whether spinal or general 
anesthesia is safer for patients such as yourself.    
 
There are potential rare serious complications from both types of anesthesia. Potential rare risks 
of general anesthesia include problems with the heart, lungs, and cognition (thinking) after 
surgery. These complications may be more likely with older patients. Potential rare risks of 
spinal anesthesia include spinal cord injury. Older patients are more likely to have conditions 
that increase the risk of spinal cord injury. Most patients having spinal anesthesia for foot and 
ankle surgery receive intravenous sedation, so that they are ‘asleep’ during surgery. Sedation has 


 
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potential rare serious complications such as problems with the lungs and cognition (thinking) 
after surgery. 
 
There are less serious potential risks from general anesthesia and spinal anesthesia. It is possible 
that patients receiving general anesthesia will be more likely to have a sore throat from the tube 
used to keep the airway open (a laryngeal mask airway will be used if possible). Some studies 
suggest that nausea and vomiting are more likely with general anesthesia (but a recent study at 
HSS showed no nausea after general anesthesia). It is possible to have a headache or backache 
after spinal anesthesia, but most headaches and backaches after surgery are not from the 
anesthetic. If you experience prolonged numbness from the spinal, this may cause a longer stay 
in the hospital, but this possible delay is in terms of hours. We will attempt to avoid prolonged 
numbness from the spinal by choosing an appropriate amount of local anesthetic.   
 
Participation in this research involves the potential risk of a breach of confidentiality to your 
stored health information.  HSS tries to minimize those risks by (i) removing some direct 
identifiers from stored information (i.e., names, social security numbers, medical record 
numbers); (ii) securing, in a separate location, and limiting access to information that would 
identify you; and (iii) limiting access to information stored to HSS investigators. 
 
There may be risks or side effects that are unknown at this time. If we learn about new risks that 
may affect your willingness to continue your participation, we will make you aware of them and 
you will be asked to re-consent to continue your participate in the study. 
 
 
4.  WHAT BENEFIT CAN YOU EXPECT?  
 
This study is comparing two standard of care procedures to determine which may be more 
effective.  The knowledge gained from this study may benefit others in the future. 
 
 
5.  COST  
 
Those research procedures (i.e. study questionnaires) listed in Section 2 will be covered by the 
study and will not be your financial responsibility.   
 
As indicated in Section 2, those costs which are considered Standard of Care for your treatment 
here at Hospital for Special Surgery will be your/or your insurance’s responsibility.  You will be 
responsible for any co-pays, deductibles, and co-insurance associated with your medical care, 
just as you would be for any costs billed to your health insurance outside of this study.  You will 
also be financially responsible for any medical care costs not covered by your health insurance. 
 
HSS is committed to providing financial assistance when financially warranted and consistent 
with its resources, regardless of age, gender, religion, race or sexual orientation.  So if you do not 
have health insurance, or if your health insurance does not pay for your medical care, you may 
seek financial assistance from HSS.  Eligibility determinations are made on a case-by-case basis 


 
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in accordance with HSS’s financial assistance policy.  You will be responsible for any costs not 
covered by financial assistance, which could be all of the costs (if HSS determines that you are 
not eligible for financial assistance) or some of the costs (if financial assistance awarded by HSS 
does not cover all of the costs). For more information about the Financial Assistance Program or 
to request a Financial Assistance Application call (212) 606-1505 to speak with a Financial 
Assistance Counselor or you can visit the following site:  http://www.hss.edu/patient-financial-
assistance-notice.asp. 
 
 
6.  PREGNANCY  
 
Due to inherent risks, HSS policy prevents pregnant women from receiving the type of 
intervention needed to qualify for this research study.  Therefore, women who are pregnant or 
nursing a child may not participate in this study.  You must confirm that, to the best of your 
knowledge, you are not now pregnant, and that you do not intend to become pregnant. If you 
suspect that you have become pregnant during this study, you must notify the study doctor 
immediately.  
 
 
7.  PAYMENT FOR PARTICIPATION 
 
You will not be paid for your participation in this study.   
 
 
8.  COMMERCIAL ISSUES:  YOUR RIGHTS IN THE RESULTS OF THE STUDY 
 
There are no plans to compensate you for the use of the findings of this study, or any of the 
information or biologic materials (such as blood or tissue) collected from you during the study, 
even if they are used to develop or make a commercial product (such as a drug, device, biologic 
substance, or test).   
 
 
9.  ALTERNATIVES:  WHAT OTHER TREATMENT IS AVAILABLE IF YOU DON’T 
WANT TO BE IN THE STUDY?  
 
You do not have to participate in this study to receive treatment for your condition.   
 
Your participation in the study is voluntary, and if you decide not to participate in the study you 
will receive the standard of care anesthesia including peripheral nerve blocks, and spinal or 
general anesthesia based on your medical condition and your preference. 
 
 
10.  WHO WILL BE ABLE TO SEE YOUR RECORDS AND PERSONAL 
INFORMATION AND KNOW THAT YOU ARE IN THE STUDY? 
 


 
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Federal regulations give you certain rights related to your health information.  These include the 
right to know who will be able to see your information and why they will be able to see it.  The 
study doctor must obtain your authorization (permission) to use or give out any health 
information that might identify you.  
 
What information may be used or given to others?   
 
If you choose to be in the study, the study doctor will get personal information about you.  The 
information might identify you.  The study doctor may also get information about your health 
including:  
 
 Medical and research records 
 Records about phone calls 
 Records about your study visits  
 Records of physical exams 
 Laboratory, x-ray, and other test results 
 Questionnaires 
 Records about any study device you received 
 
Who may use, disclose, or receive my information? 
  
The following person(s) class(es) of persons, and/or organization(s) may use, disclose, or receive 
my information: 
 The Principal Investigator and other Investigators for this study, including your study 
doctor. 
 The research coordinator, research nurses, and other members of the HSS research team 
working on this study. 
 Every research site for this study, including Hospital for Special Surgery and its affiliates, 
New York-Presbyterian Hospital, and Memorial Sloan-Kettering Cancer Center.  This 
includes the research staff and medical staff at each institution. 
 The Patient Advocate or Research Ombudsman at these institutions. 
 Staff members of HSS responsible for administering clinical trials and other research 
activities 
 Any laboratories and other individuals and organizations that analyze your health 
information for this study. 
 Any health care provider that you have used in the past or may use up to the time this study 
ends. 
 The sponsor of this study. “Sponsor” includes any persons or companies that are working 
for or with the sponsor, or are owned by the sponsor.  
 Any Contract Research Organization (CRO) the sponsor may use. (A CRO is an 
independent entity with which a research sponsor contracts to oversee and facilitate various 
aspects of the clinical research process on the research sponsor’s behalf.) 
 The United States Food and Drug Administration (FDA), the federal Office for Human 
Research Protections (OHRP), any federal agency that provides support for this study, and 


 
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any federal, state, or local agency responsible for overseeing HSS, the study doctor, or any 
other member of the HSS research team involved in this study. 
 The members and staff of the affiliated Institutional Review Boards (IRBs) at HSS, New 
York-Presbyterian Hospital, and Memorial Sloan-Kettering Cancer Center. An IRB is a 
committee of health care providers, community representatives, and others that initially 
approves and periodically reviews biomedical and behavioral research that involves human 
subjects in order to protect the rights, safety and welfare of study participants. 
 Data Safety Monitoring Boards and others authorized to monitor the conduct of this study 
for safety or quality assurance, for example a Clinical Events Committee. 
 
Why will this information be used and/or given to others?   
 
Your health information may be given to others to carry out this study.  The sponsor will analyze 
and evaluate the results of this study.  People working for the sponsor also visit HSS and other 
research sites to make sure this study is being done correctly.   
 
Your health information may be given to the FDA.  It may also be given to governmental 
agencies in other countries. This is done so the sponsor can get approval to market new products 
resulting from this study.  Your information may also be used to meet the reporting requirements 
of governmental agencies.  
 
The results of this study may be published in scientific journals or presented at medical meetings, 
but your identity will not be disclosed.   
 
What if I decide not to give permission to use and give out my health information?   
 
By signing this informed consent form, you are giving permission to use and give out your health 
information as described above.  If you refuse to give permission, you cannot be in this study.  
 
May I review or copy the information obtained from me or created about me? 
   
You have the right, in accordance with Hospital policy and applicable law, to review and copy 
your health information that is created or obtained in the course of this study.  However, if you 
decide to be in this study and sign this informed consent form, you will not be able to look at or 
copy your information until after the study is completed if doing so would impact the validity of 
the study (for example, if the study is “blinded” so that during the study you will not know what 
treatment or other intervention you are receiving). 
 
May I revoke (take back) my permission?  
 
Yes. Your permission will never expire unless you revoke it.  To revoke your permission, you 
must write to the study doctor at Hospital for Special Surgery, 535 East 70th Street, New York, 
NY 10021. 
 


 
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You may revoke your permission to use and disclose your health information at any time.  If you 
revoke your permission, you cannot continue to participate in this study.   
 
After you revoke your permission, no new health information that might identify you will be 
gathered. Information that has already been gathered may still be used and given to others. This 
would be done if the information is needed for this study to be reliable.   
 
Is my health information protected after it has been given to others?  
 
Some persons who receive your health information may not be required to protect it, and they 
may share your information with others without your permission, if permitted by laws governing 
them.  Therefore, there is a risk that your information will be released to others without your 
permission. 
 
11.  CONFLICT OF INTEREST NOTIFICATION 
  
HSS is concerned about possible conflicts of interest in research, and has policies that require all 
investigators and senior research staff to report to HSS significant financial interests (such as 
stock ownership, royalty payments, and consulting agreements) and relationships (such as 
membership on a scientific advisory board) that are related to their research studies.  When an 
investigator reports a significant financial interest or relationship that relates to one of his/her 
studies, HSS’s Conflict of Interest Committee for Research reviews the information to evaluate 
the risk that the interest or relationship might influence how the investigator conducts the study 
or interprets the results of the study.  HSS may also take steps to minimize that risk.   
 
 
The Conflict of Interest Committee for Research has determined that there are no 
conflicts of interest associated with this study. 
 
 
The Conflict of Interest Committee for Research has determined that there is a 
potential conflict of interest associated with this study.  Please read the information 
below carefully. 
 
12.  VOLUNTARY PARTICIPATION/WITHDRAWAL 
 
Your decision to take part in this study is completely voluntary.  You are free to choose not to 
take part in the study and may change your mind and withdraw at any time.  Your relationship 
with physicians at HSS and your medical care at HSS, now or in the future, will not be affected 
in any way if you withdraw or refuse to participate.  You will not lose any benefits to which you 
are otherwise entitled. 
 
The study doctor and/or the sponsor may terminate your participation in this study at any time 
without your consent if, in their judgment, it is inadvisable for you to continue.   
 


 
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13.  COMPENSATION FOR INJURY 
 
If you are injured as a result of participating in this study, the study doctor, other members of the 
research team, or other HSS professional medical staff will provide you with emergency medical 
treatment (or arrange to have such treatment provided to you), and will assist you in obtaining 
appropriate follow-up medical treatment. However, there is no plan to routinely provide 
compensation for additional medical care or other costs. 
 
Your health insurance may or may not pay for treatment of injuries as a result of your 
participation in this study.  
 
14.   SOURCE OF FUNDING  
 
Funding for this study will be provided by the Department of Anesthesiology at the Hospital for 
Special Surgery. 
 
15.  QUESTIONS   
 
If you have any additional questions later on, or if you wish to report a medical problem that may 
be related to this study, Dr. Jacques YaDeau can be reached at 212-606-1206 during office hours. 
 
If you have any questions about your rights as a participant in this study or any questions about 
your participation that you would like to ask an institutional representative who is not part of this 
study, you can call the Manager of the HSS Institutional Review Board at (212) 774-7154.  
 
If you would like to have more information about the Hospital’s financial disclosure review 
process in general, or in regard to this study, you may contact the Hospital’s Office of Legal 
Affairs at (212) 606-1592.   You may also ask the Hospital’s patient advocate at (212) 774-2403, 
to arrange for you to have this information. 
 
Do not sign this consent form unless you have had a chance to ask questions and have received 
satisfactory answers to all of your questions.  


 
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Agreement to Participate: Witnessing and Signature 
 
To be in this study, you or your legal representative must sign the next page of this informed 
consent form. By signing the next page, you are voluntarily agreeing to be in this study at HSS. 
 
Before signing, you should be sure of the following: 
 
 You have read all of the information in this “Informed Consent to Participate in Research” 
form (or had it read to you).  
 You have discussed the implications of your being in this study with your doctor, your 
study doctor and/or the study coordinator.  
 You have had the chance to ask questions about this study. 
 You received answers to your questions. 
 If you did not understand any of the answers, you asked the study doctor or the study 
coordinator to explain them to you. 
 The information given to you is based on what is now known about the study drug(s), 
device(s), or procedure(s).  There may be other risks or complications that are not known at 
this time. 
 You have had time to think about the information and decide whether or not to be in the 
study. 
 
Please check one of the following: 
 
   I AM NOT in another research study at this time. 
 
   I AM in another research study at this time. 


 
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If you decide to be in this study: 
 
 You are expected to follow the study procedures. 
 You are expected to provide the information needed by the study doctor, the study 
coordinator, nurses, or other staff members for the study. 
 You will be told in a timely manner of any significant new information that may affect 
your willingness to stay in the study. 
 You may freely choose to stop being in the study at any time. 
 
By signing below, you are voluntarily agreeing to be in this study. 
 
You must be given a signed copy of this informed consent form to keep for yourself. 
 
 
 
______________________________________ 
_______________________________________ 
Print Name of Participant  
 
 
Signature of Participant 
 
            Date 
 
______________________________________           ______________________________________ 
Print Name of Parent/Legal Guardian (if applicable)1 
Signature of Parent/Legal Guardian  
Date 
 
____________________________________ 
_______________________________________ 
Print Name of Person Obtaining Consent 
 
Signature of Person Obtaining Consent       Date 
 
 
 
_____________________________________  
As an HSS representative, please sign here to indicate that you have given a signed copy of this informed consent 
form to the participant 
 
 
NOTE TO INVESTIGATORS: 
 
THE ORIGINAL OF THIS INFORMED CONSENT FORM MUST BE PLACED IN THE 
PARTICIPANT’S STUDY FILE. 
 
A SIGNED COPY OF THIS INFORMED CONSENT FORM MUST BE GIVEN TO THE 
PARTICIPANT. 
 
A COPY OF THE INFORMED CONSENT FORM MUST BE PLACED IN THE 
PARTICIPANT’S HOSPITAL MEDICAL RECORD IF THE PARTICIPANT IS (OR WILL 
BE) HOSPITALIZED AT ANY TIME DURING THE STUDY. 
 
                                                 
1 The parent or legal guardian of a child participant should sign this form on behalf of the child.  The signature of 
one parent is sufficient when the research is of minimal risk to the child, or when the research presents the prospect 
of direct benefit to the child.  The signature of both parents is required when the research involves greater than 
minimal risk with no prospect of direct benefit to the child.  The requirements for signature of both parents may be 
waived if one parent is deceased, unknown, incompetent, or not reasonably available, or when one parent has sole 
legal responsibility for the care and custody of the child.  If the participant is a child who is capable of giving assent, 
the child should also sign the attached Assent Form.