Clinical trial NCT03201809
Conditions: Post-operative Pain
Sponsor: University of California, Davis
Start date: 2016-09-01; Completion date: 2020-03-23
Enrollment: 12 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study investigates the use of post-operative on-Q pain catheters for tissue expander based breast reconstruction, versus conventional ultrasound-guided blocks placed pre-operatively.

Detailed description:

Arms: arm 1: On-Q catheters placed within the implant pocket; infusion of 0.2% Ropivacaine at 4 mL/h for a total of 400 mL (about 4 days). arm 2: Single Shot Pre-operative injections of 10 mL of 0.25% Ropivicaine for the Pecs 1 injection, and 20 mL of 0.25% Ropivacaine for the pecs 2 injection
Interventions: intervention 1: On-Q intervention 2: Ultrasound guided pectoral nerve block
Intervention descriptions: intervention 1: 0.2% Ropivicaine at 4 mL/h via On-Q catheter placed sub-pectoral intervention 2: Single Shot Pre-operative injections of 10 mL of 0.25% Ropivicaine for the Pecs 1 injection, and 20 mL of 0.25% Ropivacaine for the Pecs 2 injection

Protocol documents:
Prot_SAP_000.pdf: 
Comparison of Preoperative Ultrasound Guided Nerve Blocks to Intraoperative Nerve Block Catheters 
for Breast Reconstruction: A Prospective Randomized Trial  
NCT03201809 
6/21/2018 
 


PROTOCOL TITLE: 
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1) 
Protocol Title 
Title: Comparison of Preoperative Ultrasound Guided Nerve Blocks to 
Intraoperative Nerve Block Catheters for Breast Reconstruction: A Prospective 
Randomized Trial        
Protocol Version Date: 6/21/18 
 
2) 
Objectives 
Aim 1: Report the efficacy and safety of pectoralis nerve blocks for breast 
reconstruction surgery in a prospective fashion 
• Hypothesis: we anticipate >90% efficacy of all pectoralis nerve blocks and 
no complications  
Aim 2: Comparison of intraoperative versus preoperative placement of pectoralis 
nerve blocks 
2A: Comparison of block efficacy and safety 
• Hypothesis: We anticipate a significantly better block efficacy with intra-
operatively placed block catheters as opposed to pre-operatively placed 
blocks, as intra-operatively placed blocks are done under direct 
visualization and can be left in place. We anticipate no difference in safety 
profile.  
2B: comparison of secondary outcomes, such as cost, block placement time, post-
op nausea/vomiting, patient satisfaction, and operative times.  
• Hypothesis: We anticipate a faster overall time (From admission to 
clearance for PACU discharge) with intra-operatively placed blocks. We 
anticipate use of less inhalational anesthesia with pre-operatively placed 
blocks. We anticipate no difference in secondary outcomes, such as post-
operative nausea and vomiting, narcotic use and patient satisfaction 
between the two block groups.  
 
3) 
Background 
Level 1 data shows improved post-operative analgesia with decreased anesthetic 
and opiate use, decreased hospital length of stay, and improved patient satisfaction scores 
with the use of regional nerve blockade.1-5 Using nerve blocks to limit general anesthesia 
(GA) and improve post-operative analgesia is additionally important due to the mounting 
evidence that volatile anesthetics and opioid analgesics impair immune function6,7, and 
increase the risk of ileus, thromboembolism and myocardial infarction8. Despite these 
advantages, the use of regional nerve blockade is still limited to selected cases.  
Pectoral nerve (Pecs) blocks are ultrasound guided inter-fascial plane blocks that 
target the tissue planes between the pectoralis major and minor (Pecs I), and pectoralis 
minor and serratus anterior muscles (Pecs II)9,10.  Targeting these planes with local 
anesthetic blocks the medial and lateral pectoral nerves, anterior divisions of the thoracic 


PROTOCOL TITLE: 
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intercostal nerves from T2-T6, long thoracic nerve, and thoracodorsal nerves providing 
analgesia to the anterior and lateral thoracic walls with an extension into axilla. Pecs 
blocks have shown excellent efficacy in post-operative analgesia after breast surgery11.  
The main disadvantages of the traditional Pecs blocks are the need for ultrasound trained 
personnel, increased anesthesia wait times as well as the need for a secondary procedure. 
Placement of the blocks under direct visualization addresses these limitations of and may 
allow more accurate plane targeting.  
This research will be significant to the fields of anesthesia/pain management, breast 
surgery and plastic surgery.  With this study, we hope to provide objective, prospective 
data on pectoralis nerve block efficacy and safety. We furthermore hope to examine the 
differences between blocks placed by anesthesia and catheter based blocks placed intra-
operatively by the surgical team, as listed above under Aims.  
 
 
1. Wu J, Buggy D, Fleischmann E, et al. Thoracic paravertebral regional anesthesia 
improves analgesia after breast cancer surgery: a randomized controlled 
multicentre clinical trial. Can J Anaesth 2015: 62: 241-51. 
2. Pei L, et al. Ultrasound-Assisted Thoracic Paravertebral Block Reduces 
Intraoperative Opioid Requirement and Improves Analgesia after Breast Cancer 
Surgery: A Randomized, Controlled, Single-Center Trial. 2015: 10: e0142249. 
3. Moller JF, Nikolajsen L, Rodt SA, Ronning H, Carlsson PS. Thoracic 
paravertebral block for breast cancer surgery: a randomized double-blind study. 
Anesth Analg 2007: 105: 1848-51, table of contents. 
4. Abdallah FW, Morgan PJ, Cil T, et al. Ultrasound-guided multilevel paravertebral 
blocks and total intravenous anesthesia improve the quality of recovery after 
ambulatory breast tumor resection. Anesthesiology 2014: 120: 703-13. 
5. Wolf O, Clemens MW, Purugganan RV, et al. A Prospective, Randomized, 
Controlled Trial of Paravertebral Block versus General Anesthesia Alone for 
Prosthetic Breast Reconstruction. Plast Reconstr Surg 2016: 137: 660e-6e. 
6. Procopio MA, Rassias AJ, DeLeo JA, et al. The in vivo effects of general and 
epidural anesthesia on human immune function. Anesth Analg 2001: 93: 460-5 
7. Gong L, Dong C, Ouyang W, Qin Q. Regulatory T cells: a possible promising 
approach to cancer recurrence induced by morphine. Med Hypotheses 2013: 80: 
308-10.  
8. Joshi GP, Ogunnaike BO. Consequences of inadequate postoperative pain relief 
and chronic persistent postoperative pain. Anesthesiol Clin North America 2005: 
23: 21-36. 
9. Blanco R. The 'pecs block': a novel technique for providing analgesia after breast 
surgery. Anaesthesia 2011: 66: 847-8. 
10. Blanco R, Fajardo M, Parras Maldonado T. Ultrasound description of Pecs II 
(modified Pecs I): a novel approach to breast surgery. Rev Esp Anestesiol Reanim 
2012: 59: 470-5. 
11. Bashandy GM, Abbas DN. Pectoral nerves I and II blocks in multimodal 
analgesia for breast cancer surgery: a randomized clinical trial. Reg Anesth Pain 
Med 2015: 40: 68-74. 


PROTOCOL TITLE: 
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12. Bolin ED HN, Wilson SH. Regional Anesthesia for Breast Surgery: Techniques 
and Benefits. Current Anesthesiology Reports 2015. 
 
4) 
Inclusion and Exclusion Criteria 
Individuals will be screened for study eligibility by reviewing the operative schedule in 
advance. Criteria for inclusion will be consenting female patients over 18 years of age 
presenting for immediate breast reconstruction with sub-muscular tissue expander 
placement with or without acellular dermal matrix sling. Patients with a history of 
chronic opioid use, brachial plexus injuries, or planned alternate regional anesthesia will 
be excluded from the study. Individuals under 18 years of age, pregnant women, 
prisoners and patients unable to provide consent will additionally be excluded.  
 
5) 
Study Timelines 
Subjects will be approached up to three days prior to their surgery to make them aware of 
the study. They will sign consent on the day of surgery. Pectoral nerve blocks will be 
placed in the operating room, either pre-operatively by the anesthesiologist or intra-
operatively by the surgeon. Post-operative care will be routine. Pain surveys will be 
emailed out via redcaps at 6h, 12h, and 24h post-operatively, as well as on days 2-7. A 
satisfaction survey will be emailed to the patient one week after surgery. After the 
satisfaction survey, patient participation will be complete.  
 
We anticipate completing our enrollment in 5 years, and completing data analysis by six 
months after the final patient has been enrolled.  
 
6) 
Study Endpoints 
The primary study endpoint will be after completion of study (after surgery and survey 
completion) of 252 patients (126 in each treatment arm). Secondary endpoints include 
time to PACU clearance and time to hospital discharge. Because the intervention is a 
single-shot injection, there are no specific safety endpoints. Please see below for a 
discussion of potential adverse from the pectoralis nerve blocks.  
 
7) 
Procedures Involved 
Subjects presenting for immediate breast reconstruction and meeting inclusion criteria 
will be approached pre-operatively to make them aware of the study. On the day of 
surgery, patients will be asked to sign consent for the study. Patients who sign consent 
will then undergo randomization to a study arm (pre-op placement of intra-op catheter 
placement). Randomization will be done by study personnel using the i-phone application 
“Randomizer.” Randomization will follow a blocked scheme; that is, if one patient is 
randomized to the anesthesia block group, the next will automatically get the catheter 
treatment.  This will ensure equal numbers in both study arms. After consent and 
randomization is complete, patients will be told of their study arm. Patients will then be 
asked to fill out a pre-operative pain survey discussing their baseline level of breast pain.  
 
For those randomized to the pre-op placement arm, anesthesia will perform this block 
prior to surgery but after their pre-operative survey is complete.  The anesthesia 


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department is already performs pectoralis nerve blocks on selected patients, and have the 
work flow set up for this. The dose will be 10 mL of 0.25% Ropivicaine for the pecs 1 
injection, and 20 mL of 0.25% Ropivacaine for the pecs 2 injection. Ropivacaine is a 
standard sodium channel blocking anesthetic already FDA approved for peripheral nerve 
blocks. For those randomized to the intra-operative arm, catheter placement will be 
performed after the pectoralis muscle flap has been raised, for more accurate targeting of 
the tissue planes and nerves. Blocks will be performed by the operating surgeon . Instead 
of single shot blocks, a commercially available On-Q nerve block catheter (Halyard 
Health, Alpharetta, Georgia) will be placed. Through these catheters, 0.2% Ropivacaine 
will be instilled at 4 mL/hr for a total of 400 mL (amount in standard On-Q reservoirs). 
Vitals are continuously monitored in the operative suite and in the Post Anesthesia Care 
Unit (PACU), with a high level of supervision by the anesthesiology team. In the very 
rare event of an adverse reaction to the injection, appropriate action will be taken 
immediately and in accordance with standard work-flow for local anesthetic toxicity 
(epinephrine for severe allergy or circulatory support, intravascular lipid emulsion and 
sodium bicarbonate for overdose, although our doses should not be high enough to 
precipitate this, even with inadvertent intravascular injection). If hypoxia not due to 
opioids and not responsive to supplemental oxygen is present, a chest radiograph will be 
ordered to rule out pneumothorax from inadvertent visceral pleural puncture.  
 
Post-operatively, the patients will be monitored in the PACU.  They will have standard 
anesthesia pain and nausea management orders written for (these are ordered en bloc as 
part of an already existing order set). PACU nursing staff will dose medications 
according to the written orders. PACU clearance time (which is currently time-stamped 
in the chart by the PACU resident) will be noted. Often patients will remain in PACU due 
to ward over-crowding, so actual time of PACU discharge will not be noted. Post-PACU 
hospital course will proceed as is standard of care, with PRN pain and nausea medication 
ordered. Standard hospital discharge criteria will be used for all groups.  
 
Information will be collected from all subject’s hospital stays, including time in pre-op 
holding area, time under general anesthesia, duration inhalational anesthetic, amount of 
narcotic used in morphine equivalents (divided into OR amount, and amounts in first 6, 
12, 18 and 24 hours after surgery) after surgery, incidence of nausea/vomiting, number 
and amount of antiemetic used (same time intervals as above), pain scores overall and by 
breast on the 0-10 analog scale (average over the same time intervals), time of PACU 
clearance, and time of hospital discharge. In addition, a RedCaps survey with questions 
about the patient’s pain level will be emailed pre-op and at post-op hours 6,12,24 and 
days 2-7.  
 
For patients with pain catheters, these catheters will be removed at the patient’s regularly 
scheduled post-operative appointment (generally POD 4 or 5). On-Q balls will not be 
refilled such that all catheter patients will have infusion for the same amount of time.  
 
One week after hospital discharge, subjects will be emailed a short survey through the 
RedCap survey system (see supplemental forms for survey questions). Hospital billing 


PROTOCOL TITLE: 
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will be examined with the assistance of the billing department using CPT codes and using 
publically available cost data.  
 
 
 
8) 
Data and/or Specimen Management and Confidentiality 
During the review, the investigator (or research staff) will record data collected in 
a manner that includes indirect identifiers. Additionally, a single location will 
include indirect and direct identifiers (to match the two). 
To elaborate: Subjects will be identified by a unique study ID (A = pre-op 
placement, B = intra-op placement; so 1A would be the first patient enrolled in 
the pre-op placement group). An enrollment log, including a “crib sheet” 
identifying patients by their study ID and their consent paperwork, will be kept in 
a binder. That binder will be stored in a locked cabinet in the plastic surgery Lab 
in Research Building 2.  After the IRB has been closed, study consents will be 
maintained for 3 years, and HIPAA consents for six years, in compliance with 
IRB rules and regulations.  Any data compiled off of the Electronic Medical 
Record (EMR) will be identified by subject ID only and collected onto a 
spreadsheet on the PI’s password protected computer.  
With respect to the surveys, Redcap is a mature, secure web application that has 
been used successfully by many other investigators at our institution to collect 
secure survey data.  
Data analysis will be done using http://vassarstats.net. Statistical comparisons will 
be performed across the study groups using T-test for two-group comparisons. 
 
All research personnel will be up to date with their HIPAA training.  
 
For our power analysis, we set our alpha = 0.05 and beta (power) = 0.8. Using the 
Bashandy et al. paper1, the mean morphine requirement in the PACU was 2.9 ± 
1.861 mg for the Pecs block group, and 6.9 ± 1.861 mg for the control group (p < 
0.001). Based on our preliminary experience with pre-operatively placed pecs 
blocks, we estimate that they work well about 70% of the time. If we hope to see 
a 20% improvement with more accurate plane targeting, then our average 
morphine requirement in the intra-operative placement group would be 2.3 mg. 
Therefore, we would have to enroll 126 patients in each arm to have an 80% 
chance of seeing a difference, if there truly is one.  
1. Bashandy GM, Abbas DN. Pectoral nerves I and II blocks in multimodal 
analgesia for breast cancer surgery: a randomized clinical trial. Reg 
Anesth Pain Med 2015: 40: 68-74. 


PROTOCOL TITLE: 
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9) 
Provisions to Monitor the Data to Ensure the Safety of Subjects 
The EMR of every subject who completes the injection portion of this study will 
be assessed within 24 hours of pectoralis nerve block placement. Any untoward 
events, such as intravascular injection, allergic reaction, pneumothorax or other 
unanticipated event will be assessed for its causative relationship to the pectoral 
nerve block  . We anticipate these to all be very unlikely, as the current literature 
on the pectoralis nerve blocks report a 0% complication rate (see citations, 
above). If a serious adverse event occurs, these will be reported immediately to 
the IRB and will be a trigger for an immediate suspension in enrollment and a 
review of the injection protocol with the Chiefs of both the Departments of 
Anesthesiology and Surgery. If any performer error can be identified and 
corrected, then with approval from the departments enrollment will continue. If 
not, the study will be terminated.  
We will cumulatively review the data after 20 subjects in each study arm have 
been enrolled, and then again at 50 patients, 75 patients, 100 patients, and 126 
patients.  
 
10) Withdrawal of Subjects 
There are limited circumstances in which a patient would be withdrawn from 
research, particularly without their consent. The only circumstance would be in 
the case of aborted tissue expander placement. If the plastic surgeon does not feel 
that the mastectomy flaps can support the added stress of an expander, then the 
plastic surgery portion of the procedure is aborted (standard protocol). In this 
circumstance, the pre-op block arm will already have gotten a block. No intra-
operative catheters will be placed. After awakening from anesthesia, the patient 
will be alerted to their expulsion from the study, and no other data would be 
collected regarding their hospital stay, and no survey information collected.  
Of note, a single patient was enrolled into the control arm of the study prior to this 
arm being abolished. This patient’s survey data has already been collected but 
will not be used for data analysis. Their hospital data will not be collected.  
 
11) Risks to Subjects 
The main foreseeable risk to study subjects is that the nerve block would not work 
well. In this event, subjects would be appropriately treated with adjunctive pain 
medications.  
Two very rare risks – never reported in the literature, so currently theoretical 
rather than described – are intravascular injection and pneumothorax, as outlined 
above. These could have potentially serious consequences, such as bupivacaine 
toxicity (at worst, leading to hypotension or seizure) or hypoxemia requiring chest 
tube placement and potentially other procedures. However, pectoralis nerve 
blocks have been in use for over 5 years, and more risky blocks, including the 
paravertebral block and intercostal block (both of which have higher rates 


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reported of the above complications) for over 30 years. Therefore, these risks are 
generally considered to be outweighed by the benefits of peripheral blocks.  
 
With respect to the nerve catheters, potential risks to patients with placement are 
less than with the ultrasound guided block, as these catheters are placed through 
the skin and into the mastectomy pocket under direct visualization. Additional 
risks would include the small risk of a post-operative infection related to the 
catheter. This risk will be minimized by sterile placement, a sterile dressing, and 
expeditious removal of the catheter within the first post-operative week. As these 
catheters are standard of care at UC Davis currently, this risk is generally felt to 
be acceptable.  
 
12) Potential Benefits to Subjects 
Study subjects potentially will have decreased anesthetic requirements and improved 
post-operative pain control. Decreased general anesthesia could mean less postoperative 
nausea/vomiting. Improved pain control will lead to less narcotic use and therefore may 
decrease the chance of ileus, nausea, itching and other common narcotic side effects.  
 
13) Sharing of Results with Subjects 
No additional information will be shared with subjects. 
 
14) Provisions to Protect the Privacy Interests of Subjects 
Patients will be approached about enrolling in this study in the preoperative area. Patient 
beds in this area are one bed per room; therefore, the conversation will be in private, 
between the physician and patient. Family members may be present, but this is standard 
for all preoperative consents (anesthesia consents, block consents, sometimes surgical 
consents if they are not on file). The consent process will specifically site that refusal to 
enroll will not result in any penalty, including any withholding of pain medication in the 
future. Post-operatively, no specific research contact will be made until an online 
questionnaire is sent out by email. 
 
15) Compensation for Research-Related Injury 
There is no specific compensation for study participation.  Because breast reconstruction 
is a planned procedure, all patients undergoing surgery will have insurance. Nerve blocks 
are a billable procedure, recognized by insurance companies. Any complications related 
to the procedure will likewise be covered by insurance.  
 
16) Economic Burden to Subjects 
As outlined above, the cost of the nerve blocks will be covered by insurance, and no 
additional out of pocket funds requested. There is no downtime or leave time required for 
these nerve blocks – in fact, if there is a decrease in narcotic use, then the nerve blocks 
may even hasten subject’s ability to return to work.  

ICF_001.pdf: 
Comparison of Preoperative Ultrasound Guided Nerve Blocks to Intraoperative Nerve Block Catheters 
for Breast Reconstruction: A Prospective Randomized Trial  
NCT03201809 
6/25/2018 
 


Permission to Take Part in a Human Research Study 
Page 1 of 5 
 
Version Date: cont review 6.20.18 
For IRB Use  
 
 
 
 
 
 
 
Document Revision Date: September 22, 2015 
 
Title of research study: Comparison of Preoperative Ultrasound Guided 
Nerve Blocks to Intraoperative Nerve Block Catheters for Breast 
Reconstruction: A Prospective Randomized Trial   
Investigator:   Michael S. Wong, MD   
Why am I being invited to take part in a research study? 
We invite you to take part in a research study because you are undergoing single-stage breast 
reconstruction. Literature has shown that patients undergoing this procedure may benefit from regional 
anesthesia with pectoralis nerve blocks. However, it is unknown what environment (pre-operative 
placement or intraoperative placement of block) leads to the best block outcome, and the use of long 
term pain catheters for this indication has not been studied.  
What should I know about a research study? 
(Experimental Subject's Bill of Rights)  
• Someone will explain this research study to you, including: 
o The nature and purpose of the research study. 
o The procedures to be followed. 
o Any drug or device to be used.  
o Any common or important discomforts and risks. 
o Any benefits you might expect. 
o Medical treatment, if any, that is available for complications.  
• Whether or not you take part is up to you. 
• You can choose without force, fraud, deceit, duress, coercion, or undue influence. 
• You can choose not to take part. 
• You can agree to take part now and later change your mind. 
• Whatever you decide it will not be held against you. 
• You can ask all the questions you want before you decide. 
• If you agree to take part, you will be given a signed and dated copy of this document.  
Who can I talk to? 
If you have questions, concerns, or complaints, or think the research has hurt you, talk to the research 
team at: 
Cannery Building 
3301 C St., Suite Suite 1100 
Sacramento, CA 95816 
Phone: 916-734-7844 
For non-emergency issues you can call the UCDMC Hospital Operator (916-734-2011) 24-hours a day, 
tell the Operator you are participating in a research study and you wish to talk to the Plastic Surgery 
Resident on call. In the case of an emergency, dial 911 from any phone. 
 
 
 
APPROVED by the Institutional Review Board 
at the University of California, Davis 
Protocol 
Approved 
 
 
918749
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Permission to Take Part in a Human Research Study 
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Version Date: cont review 6.20.18 
 
 
This research has been reviewed and approved by an Institutional Review Board (“IRB”). Information to 
help you understand research is on-line at http://www.research.ucdavis.edu/policiescompliance/irb-
admin/.You may talk to a IRB staff member at (916) 703-9151, hs-irbadmin@ucdavis.edu, or 2921 
Stockton Blvd, Suite 1400, Room 1429, Sacramento, CA 95817 for any of the following: 
• Your questions, concerns, or complaints are not being answered by the research team. 
• You cannot reach the research team. 
• You want to talk to someone besides the research team. 
• You have questions about your rights as a research subject. 
• You want to get information or provide input about this research. 
Why is this research being done? 
Peripheral nerve blocks decrease post-operative pain and therefore narcotic use. While their benefits are 
clear, little is known about the optimal way to place these blocks – whether it should be done in the 
operating room, or in the pre-operative area with ultrasound. We are doing this study to examine 
whether the method of block placement and pain medicine infusion through On-Q catheters impacts 
efficacy of the block, efficiency of surgery, and patient satisfaction. We hope that this research will lead 
to improved nerve blocks and increased patient satisfaction with their operative experience.  
How long will the research last? 
Your participation in this research study will include the day of your surgery and a few hours of your 
time one week after your surgery, to fill out a short online survey.  
How many people will be studied? 
We expect about 252 people here will be in this research study 
What happens if I say yes, I want to be in this research? 
If you consent to be enrolled in this research trial, you may be placed into one of two (2) research 
groups. The two groups are: Pectoralis nerve block placed by anesthesia before surgery and 
pectoralis nerve block catheter placement intra-operatively by the surgical team. Based on where 
you are in the randomization process, you will be randomized to one or the other treatment arm. The 
treatment you get will be chosen by chance, like flipping a coin. Neither you nor the study doctor will 
choose what treatment you get. You will be told your treatment group after you sign consent. 
 You will be randomized into one of the two groups 
 You will receive a treatment pre-designated by the randomization process 
 
If you are randomized to receive a pre-operative block group This block will be placed before 
surgery but after you are under general anesthesia by the anesthesia team, using ultrasound guidance. 
For the block, an anesthesiologist inject an anesthetic (numbing) medication in the vicinity of the 
sensory nerves that provide sensation to parts of your chest. The rest of your care will be entirely 
routine. You will have a normal amount of pain medication after surgery available to you to take as you 
need.  
 
 
 
 
APPROVED by the Institutional Review Board 
at the University of California, Davis 
Protocol 
Approved 
 
 
918749
June 25, 2018


Permission to Take Part in a Human Research Study 
Page 3 of 5 
 
 
Version Date: cont review 6.20.18 
 
 
If you are randomized to the catheter group: During your surgery, your surgeon will place a catheter 
underneath your pectoralis muscle, near the tissue expander. Pain medicine will infuse slowly over the 
first four days after your surgery in the vicinity of the sensory nerves that provide sensation to parts of 
your chest. These catheters will be removed at your first post-operative appointment. The rest of your 
care will be entirely routine. You will have a normal amount of pain medication after surgery available 
to you to take as you need.  
For all groups, you will complete a short survey that will be emailed to you now and at hours 6 after 
your surgery. This survey will be emailed to you again at hours 12, 27 and at post-operative day 1-7. An 
additional 10 question satisfaction  survey will be emailed to you one week after surgery. This survey 
will ask you about the success of your nerve block (if you had one) and your satisfaction with your pain 
management experience.  
What happens if I do not want to be in this research? 
You may decide not to take part in the research and it will not be held against you. You may be offered a 
pre-operatively placed nerve block outside of the study, but this will be up to your anesthesiologist. You 
can refuse a nerve block without penalty.  
What happens if I say yes, but I change my mind later? 
You can leave the research at any time and it will not be held against you. If you leave after your nerve 
block has been placed, information about your postoperative course will not be collected.  
Is there any way being in this study could be bad for me? 
While nerve blocks are generally very well tolerated, there are significant risks that you should be made 
aware of, including: bleeding including hematoma or hemorrhage, infection and/or abscess, persistent 
injection site pain, no pain relief or worsened overall pain, temporary or permanent muscle weakness, 
temporary or permanent nerve damage, temporary or permanent paralysis, seizure, increase or decrease 
in blood pressure, abnormal heart rhythm, nausea, vomiting, chest pain, allergic or anaphylactic 
reaction, other less common temporary or permanent medication side effects, retained broken needle 
fragment. If ULTRASOUND is used: heating and burning of superficial and deep tissue.  
With respect to the nerve catheters, potential risks to patients with placement are the same as 
with the ultrasound guided block but are even less likely, as these catheters are placed under 
direct visualization. However, the risk of a post-operative infection may be very slightly 
increased.  
 
Will being in this study help me in any way? 
This study may benefit you in that if you receive a nerve block, you may have less post-operative pain 
and nausea.  
 
What happens to the information collected for the research? 
Efforts will be made to limit use or disclosure of your personal information, including research study 
and medical records, to people who have a need to review this information. We cannot promise 
complete confidentiality. Organizations that may inspect and copy your information include the IRB and 
other University of California representatives responsible for the management or oversight of this study.  
 
 
 
APPROVED by the Institutional Review Board 
at the University of California, Davis 
Protocol 
Approved 
 
 
918749
June 25, 2018


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Version Date: cont review 6.20.18 
 
 
During your participation in this research, data will be collected about you. The de-identified data will 
become the property of the University of California.  Because we access protected health information 
(e.g., your medical record), you will be asked to sign a separate form to give your permission. Your 
medical records may become part of the research record.  Federal law provides additional protections of 
your medical records and related health information. These are described in the UC Davis Health 
System Notice of Privacy Practices (http://www.ucdmc.ucdavis.edu/compliance/pdf/notice.pdf) and in 
an attached document. 
 
Can I be removed from the research without my OK? 
If you are randomized to receive the intra-operatively placed nerve block but do not undergo surgery, 
you will be withdrawn from the study.  
What else do I need to know? 
You or your health plan will be billed for the costs of routine medical care you receive during the study. 
These costs may include operating room fees, pharmacy charges, treatments, hospitalization, scans, etc. 
You will be expected to pay for the usual deductibles and co-payments, and for any routine care that is 
not covered. You will not be compensated for taking part in this study. 
For more information about possible costs, please contact the research team. The research team can 
follow UC Davis Uninsured Non-Emergency Estimate Policy (Policy ID 1883) to work with their 
department and Decision Support Services to get you a cost estimate. 
 
It is important that you promptly tell the person in charge of the research if you believe that you have 
been injured because of taking part in this study. If you are injured as a result of being in this study, the 
University of California will provide necessary medical treatment. Depending on the circumstances, the 
costs of the treatment may be covered by University or may be billed to your insurance company just 
like other medical costs. The University and the study sponsor do not normally provide any other form 
of compensation for injury.  For more information about compensation, you may call the IRB 
Administration at (916) 703-9151 or email at IRBAdmin@ucdmc.ucdavis.edu. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
APPROVED by the Institutional Review Board 
at the University of California, Davis 
Protocol 
Approved 
 
 
918749
June 25, 2018


Permission to Take Part in a Human Research Study 
Page 5 of 5 
 
 
Version Date: cont review 6.20.18 
 
 
Signature Block for Capable Adult 
 
Your signature documents your permission to take part in this research. 
 
 
 
Signature of subject 
 
Date 
 
 
Printed name of subject 
 
 
 
Signature of person obtaining consent 
 
Date 
 
 
 
Printed name of person obtaining consent 
 
 
 
 
 
APPROVED by the Institutional Review Board 
at the University of California, Davis 
Protocol 
Approved 
 
 
918749
June 25, 2018