Clinical trial NCT03324984
Conditions: Return of Motor and Sensory Blockade Anesthesia, Spinal Decrease Discharge Time Status Post Hemorrhoidectomy
Keywords: Spinal anesthesia Pain Chloroprocaine
Sponsor: Montefiore Medical Center
Start date: 2019-09-11; Completion date: 2023-02-01
Enrollment: 110 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The use of 1% Chloroprocaine (PF) spinal anesthesia will reduce the recovery times and discharge time of patients undergoing hemorrhoidectomies as compared to 0.75% bupivacaine spinal. The primary objective is to compare the recovery times (return of motor and sensory function) and discharge time (voiding time) between 2-Chloroprocaine and 0.75% bupivacaine spinal anesthesia for hemorrhoidectomies. This is a randomized, prospective study assigning patients to either 2-Chloroprocaine (PF) or 0.75% bupivacaine spinal anesthesia group.

Detailed description:
The use of 1% Chloroprocaine (PF) spinal anesthesia will reduce the recovery times and discharge time of patients undergoing hemorrhoidectomies as compared to 0.75% bupivacaine spinal. The primary objective is to compare the recovery times (return of motor and sensory function) and discharge time (voiding time) between 1% Chloroprocaine and 0.75% bupivacaine spinal anesthesia for hemorrhoidectomies. This is a randomized, prospective study assigning patients to either 1% Chloroprocaine (PF) or 0.75% bupivacaine spinal anesthesia group. Consents for participation in the study will be obtained during the patients' preoperative anesthesia evaluation. There will be no change in the primary anesthetic technique (spinal anesthesia), since these patients routinely get spinal anesthesia for hemorrhoidectomies, however there would be a change in type of local anesthetic administration. On the day of surgery, consented patients will be randomized to one of the two groups. Both the patients and the researcher who recruited the patients and collected the data will be blinded. (Research assistant will hand an enclosed envelop to the anesthesiologists performing the spinal anesthesia with the name of local anesthetic to use) Postoperatively, the PACU nurse will be ask to document return of motor and sensory function in addition to voiding time. At the time of voiding, the nurse will be asked to inform an anesthesiologist (not involved in the case) for a postoperative evaluation and a discharge note. However, if the patient cannot void once there are able to ambulate, then they stay in PACU until they are the last patient in the unit. If still unable to void, the surgeon will be informed and an ultrasound bladder scan will be used to determine the volume of urine and the patient will be straight cath. The patient will be sent home and informed if he or she cannot void by the next day, then they should call the surgeon's office to notify them and go to the emergency room.

For postoperative data collection, the routine 24hr postoperative phone calls in which nurses make to patients will be utilize, however two additional questions will be asked, 1. Presence of nerve pain in the buttocks and thighs shooting down their legs unilaterally or bilaterally, 2. Inability to void, pass flatus or defecate. If any of the symptoms are present, then the nurse will inform an anesthesiologist (not involved in the case) whom will give the patient a call and advise them on treatment protocol. The research assistant will then be informed by the anesthesiologist who made the phone call.

Arms: arm 1: 1% Chloroprocaine is an ester-linked local anesthetic with the shortest duration of action of all local anesthetics. arm 2: 0.75% bupivacaine is a amino-amide anesthetic local anesthetic. It is hyperbaric in nature due to addition of dextrose.
Interventions: intervention 1: 1% chloroprocaine intervention 2: 0.75% bupivacaine
Intervention descriptions: intervention 1: In 2018, 1% Chloroprocaine was approved by the FDA for spinal anesthesia use. intervention 2: Bupivacaine is used on label

Protocol documents:
Prot_SAP_000.pdf: 
Title: Comparison of 1% Chloroprocaine HCL vs. Bupivacaine Spinal in 
Patients Undergoing Anorectal Surgery in an Ambulatory Surgery 
Center: A Double-Blind Randomized Controlled Pilot Trial
IRB#: 2017-8414
NCT03324984
IRB Approval Date: 9/24/2019
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Comparison of 1% Chloroprocaine HCL vs. Hyperbaric Bupivacaine Spinal in Patients 
Undergoing  Anorectal Surgery in an Ambulatory Surgery Center: A Double-Blind Randomized 
Controlled Pilot Trial. 
PI:  Dr. Iyabo Muse
Assistant Investigators: Dr. Curtis Choice, Dr. Elilary Montilla Medrano
Introduction: 
Ambulatory surgical procedures continue to rise as hospital, and medical centers are finding ways to 
improve patients' satisfaction and cut the cost of hospital visit by decreasing inpatient admissions.  
According to recent reports, between 50% and 70% of all surgeries in North America are currently 
performed as outpatient procedures.1 The ideal anesthetic for ambulatory surgery cases includes one 
that will allow for balanced anesthesia and analgesia, decrease the risk of nausea and vomiting, promote 
good postoperative pain control, and hasten discharge time.  Spinal anesthesia is an excellent option for 
ambulatory surgery involving cases below the waist such as colorectal surgery (hemorrhoidectomy), 
gynecological procedures (hysteroscopy, D&C) and orthopedic procedures (knee arthroscopy, ACL, MCL, 
repairs, ankle surgery). However, some of the characteristics of spinal anesthesia such as delayed 
ambulation, pain after block regression and risk of urinary retention may limit its use thus the choice of 
local anesthetic is critical to the success of spinal anesthesia in improving overall patient satisfaction and 
time of discharge from the outpatient setting.  
In the past, long-acting local anesthetics such as hyperbaric bupivacaine, tetracaine, and 
levobupivacaine were injected intrathecally which resulted in delays in hospital discharge, prolong 
motor and sensory blockade and an increase in urinary retention.  This resulted in studies showing no 
difference in overall ambulatory surgery unit time between neuraxial technique and general anesthesia.2 
However, in recent years short-acting local anesthetics such as 1% chloroprocaine-MPF (CP), prilocaine, 
and articaine are used for ambulatory spinal anesthesia because of their fast onset, satisfying block, 
quick recovery, and minimal side effects.3   Lidocaine was the choice for short-acting local anesthetic in 
the past for outpatient procedures; however, due to the significant risk of transient neurological 
symptoms (TNS), most anesthesiologists have abandoned its use.4   Now, 1% chloroprocaine-MPF have 
become perhaps the ideal drug for a short surgical procedure due to the rapid offset of the block. 
1% Chloroprocaine is an amino-ester CP local anesthetic with a very short half-life.5 In early production, 
sodium bisulfite was added as a preservative, which was set to be the cause of several cases of transient 
neurologic symptoms in patients that had intrathecal dosing.  In recent productions, all preservatives 
and antioxidants have been removed from two of the three currently available preparations of CP.  
Preservative-free 1% chloroprocaine has been used in several retrospective and prospective studies, and 
there has been no evidence of an increase in neurotoxicity or TNS.6-8   A chart review at the Virginia 
Mason Medical Center, published in 2004, evaluated the first 122 patients receiving spinal anesthesia 
with 2-CP, another preservative free chloroprocaine, the authors did not find any transient neurological 
symptom nor any sign of neurotoxicity.9 However, postoperative pain and urinary retention have been 
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shown to exist in patients that undergo spinal anesthesia for surgeries. Most of the patients that had 
urinary retention underwent surgeries which in itself increase the risk of urinary retention such as 
transurethral resection of bladder tumor, perirectal surgery, cystoscopy, and hernia surgery. 9-11 It has 
also been reported that if no surgery-related or underlying risk factors for urinary retention are present 
and short-acting local anesthetics are used for spinal anesthesia the incidence of urinary retention is 
acceptably low.12
A majority of the studies published in the last ten years are on the use of 2-chloroprocaine in patients 
undergoing orthopedic, general and gynecological surgery.  There is a scarce study on the use of 
preservative-free 1% Chloroprocaine on colorectal surgery such as hemorrhoidectomies.  Although, 
several studies in Europe have shown its efficacy and safety in spinal anesthesia for lower extremity 
procedures.  In the United States, The Food and Drug Administration (FDA) just approved 1% 
Chloroprocaine HCL for use in spinal anesthesia and thus we expect to see more clinical publications on 
its utilization for surgical procedures.   As previously mentioned, an ideal anesthetic for spinal anesthesia 
in ambulatory surgery patients would provide a rapid onset of action, adequate potency, predictable 
duration, and decreased neurotoxicity and systemic side effects. Thus, we would like to propose a study 
were preservative-free 1% chloroprocaine HCL will be compared to hyperbaric bupivacaine in 
ambulatory anorectal surgery. The Primary outcomes will be recovery time (return of motor and sensory 
function) and fit to discharge time from the PACU.  Secondary outcomes will be evidence of hypotension 
during the case, and evidence of TNS (transient neurologic symptoms) 24hr after the procedure.
Hypothesis
The use of 1% Chloroprocaine HCl spinal anesthesia will reduce the recovery times and discharge time of 
patients undergoing hemorrhoidectomies as compared to 0.75% bupivacaine spinal.  
Primary Objective
The primary objective is to compare the recovery times (return of motor and sensory function), time of 
ambulation, and discharge time between 1% Chloroprocaine and 0.75% bupivacaine spinal anesthesia 
for anorectal surgery. 
Secondary endpoints: 
To evaluate the incidence of intraoperative hypotension after the use of 1% Chloroprocaine vs. 0.75% 
bupivacaine spinal. 
To evaluate the incidence of transient neurologic symptoms 24hrs postoperative.  
Design and Methods
This is a randomized, prospective study assigning patients to either 1% Chloroprocaine HCl or 0.75% 
bupivacaine spinal anesthesia group.  Consents for participation in the study will be obtained during the 
patients’ preoperative anesthesia evaluation.  There will be no change in the primary anesthetic 
technique (spinal anesthesia) since these patients routinely get spinal anesthesia for a variety of 
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anorectal procedure. However, there would be a change in the type of local anesthetic administration.  
On the day of surgery, consented patients will be randomized to one of the two groups. The patients, 
the researcher who recruited the patients and collected the data, will be blinded. Also, the Nurse 
Anesthetists in the operating room taking care of the patient, the discharge Anesthesiologist, and the 
PACU nurse will all be blinded.  The only unblinded individual will be the operating room 
Anesthesiologist (a different physician from discharge anesthesiologist) performing the spinal. (Research 
assistant will hand an enclosed envelope to the anesthesiologists performing the spinal anesthesia 
with the name of local anesthetic to use). 
Postoperatively, the PACU nurse will be asked to document the return of motor and sensory function, 
time of ambulation, in addition to voiding time.  At the time of voiding, the nurse will be asked to inform 
the discharging anesthesiologist (not involved in the case) for a postoperative evaluation and a 
discharge note.  Although the ability to void is not a required discharge criteria from an ambulatory 
surgery center, if a patient cannot void once they are able to ambulate, a bladder scan will be 
performed, surgeon notified if bladder distention (>300 ml), catheterization per surgeon order, and the 
patient will be sent home and informed if he or she cannot void spontaneously after 8 hours of 
catheterization, they then should notify the surgeon and go directly to the emergency department.  If a 
Foley catheter was placed, the patient will then follow up with the surgeon the next day in the office.  
For postoperative data collection, the routine 24hr postoperative phone calls in which nurses make to 
patients will be utilized. However two additional questions will be asked, 1-the presence of nerve pain in 
the buttocks and thighs shooting down their legs unilaterally or bilaterally, 2- Inability to void, pass flatus 
or defecate. If any of the symptoms are present, then the nurse will inform an anesthesiologist (not 
involved in the case) who will give the patient a call and advise them on the treatment protocol. The 
research assistant will then be informed by the anesthesiologist who made the phone call.  
Inclusion criteria
Patient undergoing  Anorectal Procedures
Age 18 and above
ASA, I-III
Exclusion criteria
Patient refusal
Inability to understand and sign informed consent
Allergic reaction to bupivacaine or other local anesthetics
Coagulopathy (INR greater than or equal to 1.5)
Use of anticoagulant drugs (Plavix, Coumadin)
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Thrombocytopenia (Platelets < 100,000)
Infection at the site
Increased intracranial pressure
Unstable spine, Spine abnormalities
History of atypical cholinesterase (CP is metabolized by cholinesterase)
Diagnosis of any disorders (i.e., benign prostatic hyperplasia, cystitis, vulvovaginitis) that would delay 
voiding  
Anticipated procedure time longer than 60 minutes
Intraoperative management
All patients will receive mild sedation for spinal anesthesia (2mg midazolam and propofol infusion). All 
patients will get spinal anesthesia. One group of patients will get 5ml (50mg) of 1% Chloroprocaine HCl, 
and the other group will get 0.8ml of 0.75% hyperbaric bupivacaine.  No narcotics or epinephrine will be 
added to the spinal.  Patients will be monitored intraoperatively with standard ASA monitors and data 
collection will be done with the epic electronic record. Any hemodynamic instability will be treated 
accordingly.  The operating room anesthesiologist performing the neuraxial anesthesia will be aware of 
the local anesthetic administered intraoperatively. However, the research assistant, patient, PACU 
nurse, and discharge anesthesiologists will be unaware of which local anesthetic was administered. 
Post-operative pain management 
All patients will be written for standard postoperative adult anesthesia order. This will include 
antiemetic, fluid and pain medication. Each patient will receive one dose of a non-steroidal anti-
inflammatory drug (NSAIDs), i.e. ketorolac and as needed dose of 25mcg of fentanyl q5mins max dose 5.  
Outcomes measure assessments
A research assistant, who is blinded to the group, will record the return of sensory, motor, ambulation, 
voiding and discharge times. The incidence of hypotension will be documented if systolic blood pressure 
after spinal drops to more than 20mmhg from baseline (Systolic blood pressure three minutes prior to 
spinal block). On post-op day 2, the research assistant will contact the patients and ask a series of 
standard questions (see below) to determine if postoperative transient neurological symptoms (TNS) 
occurred.   Transient neurologic symptoms will be defined as back pain or dysesthesia that radiated to 
the buttocks, thighs, hips, or calves and began within the first 24 h after surgery. Localized pain or 
tenderness at the injection site or lower back without radiation will not be considered TNS. If 
postoperative TNS exist, but the pain is mild, no treatment is required only reassurance to the patient 
that symptoms will subside. If the pain is severe, the recommended therapy for TNS is NSAIDs or oral 
opioid analgesic agents. The patient will be instructed to take ibuprofen 800mg every 8hrs for 3 days by 
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an anesthesiologist as long as the patient does not have any medical contraindications.  On the third 
day, the patient will be called by the anesthesiologists to determine if symptoms are improving.  
Discharge of the patient 
All the routine standard of care recommendations followed in our hospital will be maintained during the 
discharge of the patients' home. A blinded (discharge) anesthesiologist who has not been part of the 
clinical care for the patient will conduct the discharge procedure. 
Questionnaire Used to Evaluate Transient Neurologic Symptoms after Operation
 1. If 0 is no pain and 10 the worst pain imaginable, how would you rate your pain after surgery? Buttock 
pain?
2. Did you have discomfort anywhere other than the surgical site? YES or NO? If Yes, where?
3. Did you have back pain after surgery? YES or NO (If no, go to 10) If Yes, (go to 4)
4. If 0 is no pain and 10 the worst pain imaginable, how would you rate your back pain?
5. Where was the pain in your back?
6. Did the pain radiate anywhere? YES or NO. Hips R L Both; Buttocks R L Both; Thighs R L Both; Calves R 
L Both; Sacrum R L Both
7. How long did the pain last?
8. Did the pain prevent you from sleeping, sitting, lying down, walking, going to work? Circle.
9. Had you ever had back problems or similar sensations before this surgery? YES or NO?
10.  Is the pain medication prescribed to you helping with your surgical pain? YES or NO? (if no; advice 
patient to call the surgeon's office for alternate options for pain control)
 
Data to be collected
Surgery Time (min)
Intraoperative IV fluid (ml)- Goal <1000ml 
Bladder volume (upon arrival to PACU)
Voiding time (min) Bupivacaine
Voiding time (min) Chloroprocaine
Return of Motor function (Bupivacaine vs. Chloroprocaine)
Return of Sensory function (Bupivacaine vs. Chloroprocaine)
Time to Ambulation (Bupivacaine vs. Chloroprocaine)
Discharge time (Bupivacaine vs. Chloroprocaine)
Evidence of Transient Neurological Symptoms (TNS)
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Power and sample size considerations 
 In this study, the primary endpoint of the study “discharge time” is defined as the time when the 
patients are “fit to discharge” from the PACU. According to our clinical audit, patients who have received 
bupivacaine as part of their spinal anesthesia are “fit to discharge” after 240±90 minutes (4hours) stay in 
the PACU. For this study, we assume that the use of 2-Chloroprocaine will result in a clinically significant 
30% reduction in the discharge time.14  Sample size calculation for this study is based on these  
assumptions; a two-sided type –I error of 0.05, power of 80% and the proportion of patients ready to be 
“ fit to discharge” (within the pre-specified discharge time described above)  will be 70% and 40% in the  
2- chloroprocaine group and the bupivacaine group respectively.  The sample size required based on the 
above assumptions are 46 patients in each group a total of 92 patients. Additionally, we will increase the 
sample size to an additional 10% to accommodate for voiding difficulties due to unknown reasons. 
Finally to accommodate for any missing and early drop-outs we plan to enroll 55 patients in each study 
groups, a total of 110 patients will be recruited for this study.  
Data analysis plan 
 Descriptive statistics will be used to report demographic and clinical characteristics (age, gender, type 
of surgery, medications, ASA status, comorbidities). Continuous data points will be analyzed using 
Student’s t-tests or Wilcoxon rank-sum tests ( depending on the distribution of the data) and chi-square 
or Fisher’s exact tests for categorical variables. The time “fit to discharge” will be analyzed using Kaplan–
Meier curves. Additionally, data will be analyzed using a multivariable Cox proportional hazards models 
adjusting for potential covariates. Also, the proportion of patients with trouble in voiding and required 
assistance in voiding urine in the PACU will be compared between the two groups.
Randomization
Patients will be randomly assigned to one of the two groups in a 1:1 ratio. The research office will 
provide sealed envelopes with randomization allocation. On the day of surgery, the research assistant 
will hand an enclosed envelope to the anesthesiologists performing the spinal anesthesia with the name 
of local anesthetic to use.  On medical record, the group assignments will be recorded as a “study drug.” 
The key to the randomization code will be stored in the research office. In the case of emergency PI and 
other clinical members will be provided with the allocation information. The PI or the designee will 
inform the IRB and the DSMB regarding unblinding the code. The date, time and reason for breaking the 
blind will be recorded in the source document and will be entered in the appropriate section of CRF.
Data Safety Monitoring Board (DSMB)
Data safety monitoring board will be comprised of an anesthesiologist and a surgeon. All unanticipated 
serious adverse events will be reported to the DSMB. In the event of unanticipated serious adverse 
events, a continuation of the study will be at the discretion of DSMB and IRB. Periodic DSMB meetings 
will evaluate the occurrence of any study-related adverse events.   
Data Management  
 All study data will be collected and entered into the computer database. Each subject will be assigned 
to a random number code, and the key linking the code and the subject identifier will be stored in a 
locked cabinet. The computer database will be password protected and will be kept on the Montefiore 
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drive. The research manager is responsible for auditing the consistency of the data transcribed from the 
paper CRF to the computer. A protocol violation log will be maintained, and all protocol violations will 
be reported to the IRB and DSMB. The planned interim analysis (halfway through the recruitment) will 
be mainly focused on the adverse events, rather than the efficacy of the procedure.
Human safety 
Spinal anesthesia carries the risk of bleeding, infection, delayed ambulation, pain after block regression 
(back pain or TNS) and risk of urinary retention. Furthermore, local anesthetics, which are routinely used 
for spinal anesthesia, carry the risk of local anesthetic toxicity, neurotoxicity, and allergic reactions. 
However, the right choice of local anesthetic may prevent any side effects allowing for successful spinal 
anesthesia in improving overall patient satisfaction and time of discharge from the outpatient setting.  
In the past, long-acting local anesthetics such as hyperbaric bupivacaine, tetracaine, and 
levobupivacaine were injected intrathecally which resulted in delays in hospital discharge, prolong 
motor and sensory blockade and an increase in urinary retention. However, in recent years short-acting 
local anesthetics such as 1% chloroprocaine HCl, prilocaine, and mepivacaine are been used for 
ambulatory spinal anesthesia because of their fast onset, satisfying block, quick recovery, and minimal 
side effects.
In early production, sodium bisulfite was added as a preservative to chloroprocaine, which was set to be 
the cause of several cases of transient neurologic symptoms in patients that had intrathecal dosing.  In 
recent productions, all preservatives and antioxidants have been removed from two of the three 
currently available preparations of CP.  Preservative-free 2-chloroprocaine has been used in several 
retrospective and prospective studies, and there has been no evidence of an increase in neurotoxicity or 
TNS.6-8 With the new FDA approved use of 1% Chloroprocaine for spinal anesthesia, it is expected that 
there will be more research studies on the cost-effectiveness, safety profile, and practicality of using this 
drug for short surgical procedures.  
References
1.
Apfelbaum JL, Walawander CA, Grasela TH, et al. Eliminating intensive postoperative care in 
same-day surgery patients using short-acting anesthetics. Anesthesiology. 2002;97(1):66–74.
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(6):1634–1642.
3.
Förster JG. Short-acting spinal anesthesia in the ambulatory setting. Curr Opin Anaesthesiol. 
2014;27(6):597–604.
4.
Pollock JE. Transient neurologic symptoms: etiology, risk factors, and management. Reg Anesth 
Pain Med. 2002;27(6):581–586.
5.
Fanelli A, Ghisi D, Allegri M. Is spinal anaesthesia a suitable technique for ultra-short outpatient 
procedures? Acta Biomed. 2013; 84(1):76–80.
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6.
Smith KN, Kopacz DJ, McDonald SB. Spinal 2-chloroprocaine: a dose-ranging study and the effect 
of added epinephrine. Anesth Analg. 2004;98(1):81–88.
7.
Vath JS, Kopacz DJ. Spinal 2-chloroprocaine: the effect of added fentanyl. Anesth Analg. 
2004;98(1):89–94.
8.
Kouri M, Kopacz DJ. Spinal 2-chloroprocaine: a comparison with lidocaine in volunteers. Anesth 
Analg. 2004;98(1):75–80.
9.
Yoos JR, Kopacz DJ. Spinal 2-chloroprocaine for surgery: an initial 10-month experience. Anesth 
Analg. 2005;100(2):553–558.
10. Hejtmanek MR, Pollock JE. Chloroprocaine for spinal anesthesia: a retrospective analysis. Acta 
Anaesth Scand. 2011;55(3):267–272.
11. Pavlin DJ, Pavlin EG, Fitzgibbon DR, Koerschgen ME, Plitt TM. Management of bladder function 
after outpatient surgery. Anesthesiology. 1999;91(1):42–50.
12. Mulroy MF. Outpatients do not need to void after short neuraxial blocks. Anesthesiology. 
2009;111(6):1388.
13. Lacasse MA, Roy JD, Forget J, et al. Comparison of bupivacaine and 2-chloroprocaine for spinal 
anesthesia for outpatient surgery: a double-blind randomized trial. Can J Anesth. 
2011;58(4):384–391.
14. Teunkens A, Vermeulen K, Van Gerven E, Fieuws S, Van de Velde M, Rex S: Comparison of 2-
Chloroprocaine, Bupivacaine, and Lidocaine for Spinal Anesthesia in Patients Undergoing Knee 
Arthroscopy in an Outpatient Setting: A Double-Blind Randomized Controlled Trial. Regional 
anesthesia and pain medicine 2016, 41(5):576-583.
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ICF_001.pdf: 
v. 12/05/2018 
KEY INFORMATION FOR Comparison of 1%- Chloroprocaine vs. Hyperbaric Bupivacaine Spinals in Patients 
Undergoing Anorectal Surgery in an Ambulatory Surgery Center: A Double-Blind Randomized Controlled Pilot 
Trial
We are asking you to choose whether or not to volunteer for a research study about how well 1%-chloroprocaine works 
versus bupivacaine. This page is designed to give you key information to help you decide whether to participate. We have 
included detailed information after this page. Ask the research team questions. If you have questions later, the contact 
information for the research investigator in charge of the study is below.  
WHAT IS THE STUDY ABOUT AND HOW LONG WILL IT LAST?  
By doing this study, we hope to learn if 1%-chloroprocaine-HCl spinal anesthesia will reduce the recovery times and 
discharge time of patients undergoing anorectal surgeries as compared to 0.75% bupivacaine spinal. Your participation in 
this research will last until you are ready for discharge.
WHAT ARE KEY REASONS YOU MIGHT CHOOSE TO VOLUNTEER FOR THIS STUDY?
The possible benefits of taking part in this study include fast onset, satisfying block, quick recovery, and 
minimal side effects. For a complete description of benefits, refer to the Consent Document below.
WHAT ARE KEY REASONS YOU MIGHT CHOOSE NOT TO VOLUNTEER FOR THIS STUDY?
Spinal anesthesia carries the risk of bleeding, infection, delayed ambulation, pain after block regression (back pain or 
transient neurological symptoms) and risk of urinary retention. Furthermore, local anesthetics, which are routinely used for 
spinal anesthesia, carry the risk of local anesthetic toxicity, neurotoxicity, and allergic reactions. For a complete 
description of risks, refer to the Consent Document below. You can refuse to participate in the study. If you decide not to 
participate, the medical care providers at this facility will still give you all of the standard care and treatment that is 
appropriate for you. For a complete description of alternate treatment/procedures, refer to the Consent Document below.
DO YOU HAVE TO TAKE PART IN THE STUDY?
If you decide to take part in the study, it should be because you want to volunteer. You will not lose any services, benefits 
or rights or access to care you would normally have if you choose not to volunteer. 
WHAT IF YOU HAVE QUESTIONS, SUGGESTIONS OR CONCERNS?
The person in charge of the study is Dr.Iyabo Muse. If you have questions, suggestions, or concerns regarding this study 
or you want to withdraw from the study her contact information is: 718-920-4187.
If you have any questions, suggestions or concerns about your rights as a volunteer in this research, contact staff in the 
Einstein Institutional Review Board (IRB) between the business hours of 9am and 5pm EST, Monday-Friday at 718-430-
2253 or irb@einstein.yu.edu
IRB NUMBER: 2017-8414
IRB APPROVAL DATE: 03/23/2022
IRB EXPIRATION DATE: 03/22/2023


Einstein IRB Greater Than Minimal Risk Template v. 12/05/2018
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MONTEFIORE MEDICAL CENTER
DOCUMENTATION OF INFORMED CONSENT AND HIPAA AUTHORIZATION
Introduction
You are being asked to participate in a research study called Comparison of 1%- 
Chloroprocaine vs. Hyperbaric Bupivacaine Spinals in Patients Undergoing Anorectal 
Surgery in an Ambulatory Surgery Center: A Double-Blind Randomized Controlled Pilot 
Trial. Your participation is voluntary -- it is up to you whether you would like to participate. It is 
fine to say “no” now or at any time after you have started the study. If you say “no,” your 
decision will not affect any of your rights or benefits or your access to care.
The researcher in charge of this project is called the 
“Principal Investigator.” Her name is Dr. Iyabo 
Muse. You can reach Dr. Muse at: 
Office Address: 111 E 210th street
City, State Zip: Bronx, NY 10467
Telephone #: 718-920-4187
For questions about the research study, or if you 
believe you have an injury, contact the Principal 
Investigator or the IRB.
Support for this research study is provided by 
Montefiore Medical Center Department of 
Anesthesia
The Institutional Review Board (IRB) of the 
Albert Einstein College of Medicine and 
Montefiore Medical Center has approved 
this research study. The IRB # is in the 
stamp in the upper right hand corner. If you 
have questions regarding your rights as a 
research subject you may contact the IRB 
office at 718-430-2253, by e-mail at 
irb@einstein.yu.edu, or by mail:
Einstein IRB 
Albert Einstein College of Medicine
1300 Morris Park Ave., Belfer Bldg #1002
Bronx, New York 10461
Why is this study being done? 
Spinal block is a technique used to provide anesthesia during anorectal surgery.  To perform the 
spinal, we use a needle to inject medication in the back that numbs the nerves.  At our 
institution, it is the standard of care to perform anorectal surgery under spinal anesthesia using 
a drug called bupivacaine at a concentration of 0.75%. The goal of this study is to measure the 
difference, if any, between bupivacaine and another drug called 1%-chloroprocaine.  We think 
1%-chloroprocaine can decrease recovery time (time it takes the medication to wear off) and 
discharge time (time it takes before you are able to urinate and then go home).  But more 
research needs to be done to prove this.
Both drugs, 1%-chloroprocaine and bupivicaine, are approved by the U.S. Food and Drug 
Administration (FDA) to be used in spinal anesthesia. 
Why am I being asked to participate? 
You are being asked to participate in this study because you are an adult that will undergo 
anorectal surgery.  You were identified on the surgery schedule.
IRB NUMBER: 2017-8414
IRB APPROVAL DATE: 03/23/2022
IRB EXPIRATION DATE: 03/22/2023


Einstein IRB Greater Than Minimal Risk Template v. 12/05/2018
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How many people will take part in the research study?
You will be one of 110 people who will be participating in this study. 
How long will I take part in this research?
However long it takes for you to be ready for discharge is how long it’ll take for you to complete 
this research study.  You will not have to make any follow-up research related visits at 
Montefiore Medical Center after you have been discharged.
What will happen if I participate in the study? 
If you are eligible for the study, we will assign you by chance (like a coin toss) to the 1%-
Chloroprocaine group or the bupivicaine group.  You will have a 50/50 chance of being assigned 
to the either group.
If you choose to participate, you will be randomized to one of the two spinal drug groups on the 
day of surgery. Everything else that follows is the standard of care and not affected by 
participating in the research.  All patients will receive mild sedation for spinal anesthesia. All 
patients will get spinal anesthesia. You will be monitored during surgery (blood pressure, heart 
rate, and oxygenation).  After surgery, you will go to the recovery area and a nurse will care for 
you.  As a standard part of this care, the nurse will check the strength and sensation in your legs 
as well as when you can first urinate.  After you are able to urinate, you may be discharged 
home.
You will be called within 24 hours by a nurse to follow-up on how you are doing and asked 
standard questions as well as two more questions related to the research: 1. Presence of nerve 
pain in the buttocks and thighs and 2. Inability to urinate, pass gas or defecate. If any of these 
are present, this will be communicated to an anesthesiologist who will advise you further.  
Temporary inability to urinate, pass gas or defecate and nerve pain can be a side effect of 
spinal anesthesia. 
A description of this clinical trial will be available on www.ClinicalTrials.gov, as required by U.S.
law. This Web site will not include information that can identify you. The Web site will
include a summary of the results but your specific information will not be shown. You can search 
this Web site at any time.
Information Banking (Future Use and Storage)
IRB NUMBER: 2017-8414
IRB APPROVAL DATE: 03/23/2022
IRB EXPIRATION DATE: 03/22/2023
Data Stored with Identification Linking Code
We will store information about you in a “bank”, which is a library of information from many 
studies. This information can be linked to you. In the future, researchers can apply for 
permission to use the information for new studies to prevent, diagnose or treat disease, 
including genetic research. If you agree to the future use, some of your de-identified genetic and 
health information (not linked to you) may be placed into one or more scientific datab
ases. These may include 
databases maintained by the federal government. Your information may be kept for a long time, 
perhaps longer than 50 years. You may remove your consent for future research at any time by 
contacting the Principal Investigator named on the first page of the consent or the IRB office at 
718-430-2237. If you do, we will destroy the information in the bank but if the information was 
already shared with other researchers, we cannot get it back.
You can choose not to participate in the bank and still be part of the main study and this will not 


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affect your treatment at this facility.
INITIAL ONE (1) OF THE FOLLOWING OPTIONS
_______ I consent to have my information used for future research studies.
_______ I do NOT consent to have my information used for future research studies. Information 
about me will be kept as long as required by regulations and institutional policy, but will not be 
used for future studies.
INITIAL YOUR CHOICE BELOW
_______ I consent to be contacted in the future to learn about:
_______ New research protocols that I may wish to join.
_______ General information about research findings.
_______ I do not want to be contacted at all.
Will I be paid for being in this research study? 
You will not receive any payment or other compensation for taking part in this study.
Some researchers may develop tests, treatments or products that are worth money. You will not 
receive payment of any kind for your specimens and information or for any tests, treatments, 
products or other things of value that may result from the research.
Will it cost me anything to participate in this study? 
There will be no cost to you to participate in the study.
What will happen if I am injured because I took part in this study?
If you are injured as a result of this research, only immediate, essential, short-term medical 
treatment as determined by the participating hospital, will be available for the injury without 
charge to you personally. 
•
No monetary compensation will be offered.
•
You are not waiving any of your legal rights by signing this informed consent document.
•
If additional treatment is required as a result of a physical injury related to the research,
necessary medical treatment will be provided to you and billed to your insurance 
company or to you as part of your medical expenses.
Immediately report any discomforts, problems or injuries you experience during the course of 
your participation in the study to Dr. Iyabo Muse at 718-920-4187.
What else do I have to do?

You must tell the research study doctor about any past and present diseases or allergies
you are aware of and about all medications you are taking including “over-the-counter” 
remedies and nutritional supplements or herbs.

If you do not feel well at any time, call your doctor or the research study doctor
immediately. 

Please report all symptoms and reactions to drugs as well as any other complaints to the
research study doctor. 

You may carry out all your normal daily activities.
IRB NUMBER: 2017-8414
IRB APPROVAL DATE: 03/23/2022
IRB EXPIRATION DATE: 03/22/2023


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Confidentiality
The researchers and study staff follow federal and state laws to protect your privacy. This part 
of the consent form tells you what information about you may be used and shared in the 
research described in this form. You do not have to sign this form but, if you do not, you may not 
participate in the research. 
The health information that we may use or disclose for the research described in this form 
includes information from your entire medical record, such as your name, phone number, email, 
medical diagnoses, dates, test results, social security number, medical record numbers, etc
Your information and research records will be kept confidential. Your study information will be 
kept as long as they are useful for the research described in this form.
The only people who can see your research records are:

Researchers and other individuals who work with the researchers

Organizations and institutions involved in this research, including those that fund the
research, if applicable

Groups that review research such as central reviewers, Institutional Review Boards, the
Office for Human Research Protections, the US Food and Drug Administration,  data 
coordinating centers, and domestic and foreign agencies that regulate research.
The purposes of these uses and disclosures are to (1) conduct the study and (2) make sure the 
study is being done correctly. The information covered under this form may no longer be 
protected by federal privacy laws (such as HIPAA) once disclosed, and those persons who 
receive your health information may share your information with others without your additional 
permission. All of these groups have been asked to keep your information confidential. 
Medical information collected during the research, such as test results, may be entered into your 
Montefiore electronic medical record and will be available to clinicians and other staff at 
Montefiore who provide care to you. 
To maintain the integrity of this research study, you generally will not have access to your 
research-related personal health information. If it is necessary for your care, your research-
related health information will be provided to you or your physician.
Are there any risks to me? 
Risks of Chloroprocaine or Bupivacaine 
Spinal anesthesia, which is the standard of care you would receive even if you do not participate 
in the research, carries the risk of bleeding, infection, delayed walking, pain after the block 
wears off (back pain) and inability to urinate. The drugs used in the spinal can rarely cause an 
allergic reaction, seizures, and changes in your heart rhythm and blood pressure.
Allergic Reaction to Study Drug
Any drug can cause an allergic reaction which could be mild or more serious.  Common 
symptoms of an allergic reaction are rash, itching, skin problems, swelling of the face and 
throat, or trouble breathing.  But participation in this research study will not increase your risk of 
an allergic reaction.
IRB NUMBER: 2017-8414
IRB APPROVAL DATE: 03/23/2022
IRB EXPIRATION DATE: 03/22/2023


Einstein IRB Greater Than Minimal Risk Template v. 12/05/2018
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Unknown Risks
We have described all the risks we know. However, because this is research, there a possibility 
that you will have a reaction that we do not know about yet and is not expected.
Are there possible benefits to me? 
You may or may not receive personal, direct benefit from taking part in this study. The possible 
benefits of taking part in this study include fast onset, satisfying block, quick recovery, and 
minimal side effects.
What choices do I have other than participating in this study?
You can refuse to participate in the study. If you decide not to participate, the medical care 
providers at this facility will still give you all of the standard care and treatment that is 
appropriate for you.
Are there any consequences to me if I decide to stop participating in this study?
No. If you decide to take part, you are free to stop participating at any time without giving a 
reason. This will not affect your care and you will continue to be treated at this facility. However, 
some of the information may have already been entered into the study and that will not be 
removed. The researchers may continue to use and share the information they have already 
collected.
To revoke (take back) your consent and authorization, you must contact the Principal 
Investigator in writing at the address on page 1 of this form. However, you may first call or 
speak to the Principal Investigator and she will stop collecting new information about you.  If you 
take back your consent and authorization, you will not be allowed to continue to participate in 
this research study. 
CONSENT TO PARTICIPATE
I have read the consent form and I understand that it is up to me whether or not I participate. I 
know enough about the purpose, methods, risks and benefits of the research study to decide 
that I want to take part in it. I understand that I am not waiving any of my legal rights by signing 
this informed consent document. I will be given a signed copy of this consent form.
Printed name of participant
Signature of participant
Date
Time
Printed name of the person 
conducting the consent 
process
Signature
Date
Time
IRB NUMBER: 2017-8414
IRB APPROVAL DATE: 03/23/2022
IRB EXPIRATION DATE: 03/22/2023