Clinical trial NCT03383588
Conditions: Pain, Referred
Sponsor: Montefiore Medical Center
Start date: 2018-07-19; Completion date: 2018-12-31
Enrollment: 26 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if giving an injection of numbing medication at the incision at the end of cesarean will help control pain AFTER cesarean delivery. This study seeks to assess pain relief with incisional infiltration of local anesthetic during cesareans performed under spinal anesthesia also using intrathecal opioids. Participants will receive the usual regimen of pain medication in spinal anesthesia. At the end of the cesarean delivery, while the participants are still under the spinal medication, participants will receive an injection, at the incision, either numbing medication (with or without epinephrine) or sterile saline. After the cesarean delivery, participants will receive, by mouth, commonly prescribed pain medications - these medications are oxycodone (an opioid/ narcotic), acetaminophen (or more commonly known as Tylenol), and ibuprofen.

Detailed description:
The study assesses addition of subcutaneous bupivacaine with and without epinephrine to the standard intrathecal morphine/fentanyl combination given during spinal anesthesia during elective cesarean delivery on postoperative pain control as measured by postoperative usage of oral opioids and a postoperative pain assessment scale. Comparing post-op pain scores and oxycodone usage in patients who receive just intrathecal morphine to patients who receive intrathecal morphine plus subcutaneous bupivacaine .25%, to patients who receive bupivacaine .25% with epinephrine 1:200,000.

After cesarean delivery, all groups will actively control the use of post-operative pain medication by indicating to the care nurse whether or not pain medication is desired. Pain control for all groups will be the standard pain treatment: ibuprofen for mild to moderate pain and percocet (oxycodone) for severe pain.

The U.S. Food and Drug Administration (FDA) has approved bupivicaine as an anesthetic and for pain but the FDA has not approved bupivicaine to be given specifically for postoperative cesarean pain. Acetaminophen, oxycodone and ibuprofen are being used as part of routine clinical care for pain control after cesarean. Fentanyl and duramorph are being used in spinal anesthesia and are FDA approved for regional anesthesia and used for this purpose in routine clinical care.

Arms: arm 1: standard intrathecal bupivacaine (Marcaine) 0.75% 1.5-1.7 ml, intrathecal morphine (Duramorph) 150mcg plus intrathecal fentanyl 10 mcg + 20 ml subcutaneous bupivacaine (Marcaine) 0.25% arm 2: standard intrathecal bupivacaine (Marcaine) 0.75% 1.5-1.7 ml, intrathecal morphine (Duramorph) 150mcg plus intrathecal fentanyl 10 mcg + 20 ml subcutaneous bupivacaine (Marcaine) 0.25% with Epinephrine arm 3: standard intrathecal bupivacaine (Marcaine) 0.75% 1.5-1.7 ml, intrathecal morphine (Duramorph) 150mcg plus intrathecal fentanyl 10 mcg + 20 ml subcutaneous NACL 0.9% (placebo)
Interventions: intervention 1: Bupivacaine intervention 2: Morphine intervention 3: Fentanyl intervention 4: Epinephrine intervention 5: Saline solution
Intervention descriptions: intervention 1: 20 ml subcutaneous bupivacaine (Marcaine) 0.25%. Bupivacaine is an anesthetic which can numb an area of the body to relieve pain during surgery or medical procedures, childbirth, and dental work. intervention 2: intrathecal morphine (Duramorph) 150mcg. DURAMORPH (morphine injection) is a systemic narcotic analgesic for administration by the intravenous, epidural or intrathecal routes. It is used for the management of pain not responsive to non-narcotic analgesics. DURAMORPH (morphine injection) administered epidurally or intrathecally, provides pain relief for extended periods without attendant loss of motor, sensory or sympathetic function. intervention 3: intrathecal fentanyl 10 mcg. Fentanyl (also spelled fentanil) is an opioid which is used as a pain medication and together with other medications for anesthesia. intervention 4: Epinephrine injection is used along with emergency medical treatment to treat life-threatening allergic reactions caused by insect bites or stings, foods, medications, latex, and other causes. Epinephrine is in a class of medications called alpha- and beta-adrenergic agonists (sympathomimetic agents). It works by relaxing the muscles in the airways and tightening the blood vessels. intervention 5: 20 ml subcutaneous NACL 0.9% - saline solution is the placebo

Protocol documents:
Prot_SAP_001.pdf: 
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IRB# 2017-8094
Title: Efficacy of subcutaneous infiltration with local anesthetic during elective 
cesarean delivery for postoperative pain control: a randomized controlled trial 
Study Contact Information
Principal investigator:
Jeffrey Bernstein, MD
Professor of Anesthesia
1825 Eastchester Road
Bronx, NY 10461
Telephone: 718-904-2872
Co-investigators:
Catherine M. Igel, MD
Maternal Fetal Medicine Fellow
Department of Obstetrics & Gynecology 
Montefiore Medical Center
Jack D. Weiler Hospital
1825 Eastchester Road
Bronx, NY 10461 USA
Telephone: 925-786-0704
Email: cigel@montefiore.org 
Peter Bernstein, MD, MPH
Professor of Clinical Obstetrics & Gynecology and Women’s Health
Montefiore Medical Center
Jack D. Weiler Hospital
1825 Eastchester Road
Bronx, NY 10461 USA
Telephone: 718-904-2767
Email: pbernste@montefiore.org
Background/Significance
Cesarean delivery is the most common operation performed throughout the world with 
estimates in the United States at 30% of all deliveries being performed via cesarean section. 
Spinal anesthesia is the standard of care for elective cesarean births given its maternal and 
neonatal safety profile. Typical post-cesarean pain relief varies by institution and provider 
preference but typically consists of an oral narcotic with or without an oral non-steroidal anti-
inflammatory inhibitor. Post-cesarean analgesia studies, especially considering the growing 
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opioid abuse epidemic, are of suboptimal quality. In fact, a 2015 Cochrane review noted that 
due to limited data available no conclusions could be drawn on the safest and most effective 
oral analgesics for post-cesarean pain relief.1 
Given its success in showing improved postoperative pain in other surgical procedures, there 
are multiple studies showing the benefit of a Transversus Abdominis Plane (TAP) block at the 
time of cesarean delivery.2–5 However, TAP blocks are long procedures requiring specialized 
training and an ultrasound for guidance. One study by Tawfik et al.4 showed no difference in 
pain scores, opiod consumption or maternal satisfaction scores with TAP vs local infiltration. 
Studies have also been performed assessing placement of pain management systems into the 
incision to release local anesthetics or analgesics over time, however these results have also 
been mixed.6
Multiple studies have been performed in the past assessing local infiltration of multiple 
different kinds of anesthetic and pain medications either before cesarean delivery begins or at 
the end of the procedure for pain control.7,8,17–19,9–16 These studies have had conflicting results 
on the utility of local anesthetics for postoperative pain control. A Cochrane review from 2009 
noted that local infiltration was likely beneficial in reducing postoperative opiod consumption 
but not visual analog pain scales.20 A metanalysis published in 2017 also noted that local 
infiltration was likely beneficial in reducing postoperative opiod consumption but its utility 
when used in combination with intrathecal opiods in spinal regimens (as is now the standard of 
care in obstetrical anesthesia) required more data.21  
 
The most recently published randomized controlled trial on this topic is from Egypt in 2016 
assessing postoperative pain with local infiltration of lidocaine versus lidocaine with 
epinephrine in women undergoing general anesthesia.22 This study demonstrated safety of 
both regimens and showed improved pain relief for women receiving lidocaine with 
epinephrine. Our study seeks to assess pain relief with incisional infiltration of local anesthetic 
(with and without epinephrine) during cesareans performed under spinal anesthesia also using 
intrathecal opiods. Our study is more relevant given the infrequency of cesareans performed 
under general anesthesia in the United States. We will also be assessing women who receive no 
local infiltration of anesthetic, the current standard of care, as our control group. 
Multiple professional societies and government agencies have recommended a decrease in the 
use of opioids for postoperative analgesia given the opiod misuse epidemic. Our study attempts 
to further assess postoperative oral opioid consumption in patients undergoing spinal 
anesthesia with intrathecal opiods by assessing the addition of local subcutaneous infiltration 
of anesthetic.
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Study Design
Objective: The objective of our study is to assess the addition of subcutaneous bupivacaine 
(Marcaine) with or without epinephrine to the standard intrathecal morphine/fentanyl 
combination given during spinal anesthesia during elective cesarean delivery on postoperative 
pain control as measured by postoperative usage of oral opioids and a postoperative pain 
assessment scale.
Hypothesis: The addition of subcutaneous bupivacaine with epinephrine at the cesarean 
incision site prior to skin closure to the standard spinal anesthesia regimen at the time of 
elective cesarean delivery will reduce postoperative narcotic usage in the first 24 hours 
postoperatively by 25%
Null Hypothesis: There will be no difference in postoperative narcotic usage in the first 24 
hours after cesarean delivery with the addition of subcutaneous bupivacaine with or without 
epinephrine at the cesarean incision site prior to skin closure at the time of elective cesarean 
delivery.
Methods: Trial will be registered on ClinicalTrials.gov and follow CONSORT guidelines

Type of study: 3 arm, blinded, randomized controlled trial involving patients who 
receive spinal anesthesia for elective cesarean delivery
o
Randomization: Subjects will be randomized using the blocking method. To 
achieve comparable groups, we will randomize enrollees to one of three 
treatment arms. Randomization will be done with block sizes of 6 to reduce 
the likelihood of unmasking the randomized assignment.  All potential 
subjects will be randomized prior to study start (patient’s # 001- 276) and the 
group that they are randomly assigned to will be written on cards placed into 
pre-sealed envelopes.
o
Blinding: The envelopes will not be opened, and the subjects’ group not 
known, until immediately prior to the subjects’ cesarean delivery to maintain 
the randomization process. Only the physicians drawing up and supplying the 
medication (the anesthesia physicians- resident and attending) will be aware 
of the patients group.  The physicians administering the medication (i.e. the 
OBGYN attending and resident) will NOT be told the composition of what 
they are injecting. The patient will be blinded to (i.e. will not be told) their 
intervention group. The investigator collecting the data will be blinded to (i.e. 
not know) which intervention group each individual patient was assigned to 
while collecting the data. Therefore, the patient, the physician administering 
the medication, and the personnel collecting the data will all be blinded to 
the patient’s intervention group. The anesthesia team will only record the 
patient’s pre-assigned number into the medical record (EPIC electronic 
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health record) and mention that they received an injection at incision closure 
of “study drug- patient #001-276.” The master list of what each patient 
received (i.e. the key to the randomization) will be kept with the anesthesia 
team and no one else will have access to view the key to maintain blinding. 
o
Groups: Injection will consist of 5 ml of either bupivacaine 0.25%, bupivacaine 
0.25% + epinephrine, or NACL 0.9% infiltrated subcutaneously in 4 
approximately equidistant injections sites in the subcutaneous tissue (2 sites 
in the cephalad portion and 2 sites in the caudad portion) after closure of 
fascia and prior to subcutaneous closure (if performed) and skin closure at 
the cesarean section incision site. Total volume infiltrated will consist of 20 
ml.

Group 1 (intervention 1): standard intrathecal bupivacaine 
(Marcaine) 0.75% 1.5-1.7 ml, intrathecal morphine (Duramorph) 
150mcg plus intrathecal fentanyl 10 mcg + 20 ml subcutaneous 
bupivacaine (Marcaine) 0.25% 

Group 2 (intervention 2): standard intrathecal bupivacaine 
(Marcaine) 0.75% 1.5-1.7 ml, intrathecal morphine (Duramorph) 
150mcg plus intrathecal fentanyl 10 mcg + 20 ml subcutaneous 
bupivacaine (Marcaine) 0.25% with Epinephrine 

Group 3 (control/standard therapy group): standard intrathecal 
bupivacaine (Marcaine) 0.75% 1.5-1.7 ml, intrathecal morphine 
(Duramorph) 150mcg plus intrathecal fentanyl 10 mcg + 20 ml 
subcutaneous NACL 0.9% (placebo)

All groups: post-operative pain control- as assessed per routine 
nursing protocol during the first 24 hours postoperatively

Routine post-cesarean oral analgesics:
o
Ibuprofen 600 mg PO prn mild (1-3); moderate (4-6); 
severe (7-10) pain
o
Percocet prn severe pain (7-10) if unrelieved by 
ibuprofen 

Routine nursing protocol for postoperative pain assessment 
consists of patient assessment (pain scale 1-10) every hour for 
the first 2-4 hours postoperatively while the patient is in the 
PACU and every 1-4 hours for the remainder of their hospital 
stay while the patient is on the postpartum unit. The pain 
scale will be recorded in EPIC at a minimum of every 4 hours 
postoperatively. 

Primary outcome: postoperative pain medication usage
o
Documented postoperative usage of cumulative opioid pain medication 
(oxycodone in morphine equivalents) in the first 24 hours postoperatively
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
Secondary outcomes: 
o
Documented postoperative usage of pain medication 

cumulative usage of postoperative pain medication- opioid 
(oxycodone) (at 4 hours, 8 hours, 12 hours, 24 hours, 36 hours, 48 
hours postoperatively)
o
Time to first postoperative pain medication
o
Need for additional breakthrough pain medication outside of protocol 
(amount and type of medication will be documented)
o
Subjective patient pain assessment

immediate postoperative pain scale performed in postoperative 
anesthesia care unit (PACU) and throughout the postoperative period 
according to current nursing protocol (see above)

Patient satisfaction with pain management
o
Time to return of bowel function
o
Time to discharge from the recovery room
o
Time to first ambulation
o
Breastfeeding during hospital stay (assessment of both initiation of and 
exclusive breastfeeding)
o
Maternal side effects/outcomes

Intraoperative: hypotension, nausea, vomiting, pruritus, respiratory 
depression, prolonged numbness or immobility, failed neuraxial 
anesthesia requiring intubation, systemic toxicity of local anesthesia 

Postoperative: fever, postoperative wound separation, postoperative 
wound infection, skin site irritation, incisional hematoma/seroma 
formation
o
Other variables to be collected:

Demographic

Maternal: Age, gravidy, parity, number of prior cesarean 
deliveries, number of prior surgeries, maternal co-morbidities 
(chronic hypertension, gestational hypertension, 
preeclampsia, diabetes mellitus -pregestational, gestational- 
diet or medication controlled- autoimmune disease, known 
pain syndromes- i.e. fibromyalgia, etc.), reason for current 
cesarean delivery, history of tobacco use, history of anxiety or 
depression, amniotic membrane status, body mass index, 
ethnicity

Fetal: gestational age, suspected intrauterine growth 
restriction, estimated fetal weight, known or suspected 
congenital or chromosomal anomalies, placenta previa

Intraoperative variables
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
Length of surgery, estimated blood loss, intraoperative 
complications, concurrent bilateral tubal ligation, any other 
analgesia given intraoperatively and amount of other 
anesthetic given 

Postoperative variables

Neonatal outcomes (will be stratified based on fetal 
gestational age as this study includes all gestational ages and 
neonatal outcomes will likely be affected by gestational age; 
we will therefore stratify results by completed weeks of 
gestation: >37 weeks, 34-37 weeks, 30-34 weeks, <30 weeks)
o
APGARS, APGAR <7 at 5 min, fetal arterial blood gas pH 
and base deficit, neonatal intensive care unit 
admission, fetal weight

Study Population: all pregnant female patients who will be undergoing an elective 
cesarean delivery under spinal anesthesia at any gestational age
o
Inclusion criteria: 

Elective cesarean delivery with or without planned bilateral tubal 
ligation

Planned spinal anesthesia 

Planned Pfannenstiel or low transverse skin incision  
o
Exclusion criteria: 

Known maternal allergy to bupivacaine or derivative 

Known maternal allergy to oxycodone, ibuprofen, acetaminophen or 
derivative

Currently have an epidural catheter in place

Planned general anesthesia  

Maternal age <18 years old

Emergent cesarean delivery

Active labor [defined as: >6cm cervical dilation and regular 
contractions noted on tocometer (>2 contractions in a 10 minute 
period for 30 consecutive minutes)]

Chronic antepartum opioid use 

History of substance abuse (alcohol or drug)

Current tobacco use

Chronic steroid use or needing stress dose steroids at the time of 
delivery

Medical contraindication to neuraxial anesthesia such as 
thrombocytopenia (platelet count <80,000/microliter) or space 
occupying lesion of the brain

Category 3 fetal heart rate pattern
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
Maternal fever or suspected chorioamnionitis

Concern for morbidly adherent placenta

Planned cesarean hysterectomy

Power analysis: 
o
Sample size was determined assuming a power of 80%, p value of 0.05 to 
detect a 25% difference in the primary outcome of cumulative opioid usage 
in the first 24 hours postoperatively 

In a previous unpublished, randomized controlled study conducted by 
Dr. Jeffrey Bernstein, average use of opioids in post-cesarean 
subjects was 47mgSD 35 morphine equivalence in the first 24 hours 
postoperatively 

Therefore, in our protocol, with three groups and keeping the 
hypothesis as one of the groups will consume fewer opioids (SD as 25) 
to demonstrate a minimum 25% difference between any two groups, 
this will require 255 subjects total (85 subjects per group). However, 
to accommodate for missing data and study withdrawal we will 
increase the sample size by 10 % therefore there will be 276 subjects 
total- or 92 patients per group

Exclusion of any population group: 
o
Minors <18 will be excluded

There are regulations for protection of human subjects allow 
consenting adults to accept a higher level of risk than is permitted for 
children
o
Only subjects who have the capacity to consent will be enrolled

Sources of research material:
o
Data and access to the electronic medical records (EPIC, EPF, ASOBGYN) will 
be obtained from individually identifiable living human subjects as part of 
routine clinical care.

Participant recruitment: Study team members (i.e. key personnel) on labor and 
delivery will ask patients who present for elective cesarean delivery if they are 
interested in the study. The key personnel will then approach the intended patients 
to obtain consent for the research study. We are requesting a waiver of informed 
consent and HIPAA authorization to access medical records for recruitment 
purposes. 
o
All patients will be told that the study is voluntary, they do not have to 
participate and whether they participate will not affect their care in any way
o
Maintenance of safety of PHI data/confidentiality

All records will be kept in a secure manner on a secure server. Access 
to the records will only be by the listed protocol key personnel and 
the computer records will be password protected. All patients will be 
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assigned a number and all information will be recorded under this 
number - not patient identifying information - and a separate list will 
be kept in a separate location under password protection listing 
medical records of patients identified to the code and only researcher 
Igel will have access to this list. 

Informed consent
o
The informed consent document adhering to Montefiore’s template is 
uploaded to IRIS.
o
Informed consent will be obtained by listed key personnel when the patients 
present to the labor and delivery unit. These patients will be approached 
based on the inclusion/exclusion criteria noted above and will NOT be 
women in labor as outlined in the exclusion criteria. They are women for 
elective cesarean delivery.
o
There will be no waiver of informed consent and minors will not be included
o
There is no cost or remuneration to the participants 
o
HIPPAA authorization will take place at the same time as the informed 
consent process

Risks/Benefits
o
Anticipated risks (e.g. medical, social, psychological, and/or legal)

The anticipated medical risks involved with the addition of 
bupivacaine include possible allergic reaction, systemic toxicity or 
intravascular injection of the anesthetic. There are no social or legal 
risks.  Psychological risks include discomfort completing 
questionnaires and breach of confidentiality/ loss of privacy. 

Risks of injection process include: pain, redness, infection or allergy to 
medication components 

Adverse reactions of study medications according to FDA:

Oxycodone: abuse, misuse, addiction; (>5%): constipation, 
nausea, somnolence, dizziness, vomiting, pruritus, dry mouth, 
sweating, asthenia; (1-5%) anorexia, nervousness, insomnia, 
fever, confusion, diarrhea, abdominal pain, dyspepsia, rash, 
anxiety, euphoria, dyspnea, postural hypotension, chills, 
twitching, gastritis, abnormal dreams, thought abnormalities, 
hiccups; (<1%): lymphadenopathy, palpitations, tinnitus, 
syndrome of inappropriate antidiuretic hormone secretion, 
abnormal vision, dysphagia, flatulence, ileus, stomatitis, 
increased appetite, eructation, chest pain, edema, facial 
edema, malaise, pain, peripheral edema, thirst, withdrawal 
syndrome (with and without seizures), anaphylactic or 
anaphylactoid reaction, pharyngitis, accidental injury, 
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hyponatremia, increased hepatic enzymes, ST depression, 
dehydration, neck pain, abnormal gait, amnesia, hyperkinesia, 
hypertonia (muscular), hypesthesia, hypotonia, migraine, 
paresthesia, seizures, speech disorder, stupor, syncope, taste 
perversion, tremor, vertigo, agitation, depersonalization, 
depression, emotional lability, hallucination, dysuria, 
hematuria, polyuria, urinary retention, urination impaired, 
amenorrhea, decreased libido, impotence, cough increased, 
voice alteration, dry skin, exfoliative dermatitis, urticarial, 
vasodilation

Acetaminophen: (>3%) nausea, vomiting, headache, insomnia, 
pyrexia; (>1%): anemia, fatigue, infusion site pain, peripheral 
edema, aspartate aminotransferase increased, breath sounds 
abnormal, hypokalemia, muscle spasms, trismus, anxiety, 
dyspnea, hypertension, hypotension

Ibuprofen: (>1% but <3%) Nausea, stomach pain, heartburn, 
vomiting, constipation, abdominal cramps, bloating, gas, 
dizziness, headache, nervousness, rash, itching, ringing in ears, 
decreased appetite, swelling, fluid retention; (<1%): ulcer, 
bleeding ulcer, black stools, abnormal liver function tests, 
inflammation of liver/ pancreas/ stomach, depression, 
difficulty sleeping, confusion, sleepiness, hives, thinning of 
hair, Stevens Johnson syndrome, hearing loss, blurred vision 
or changes in vision, neutropenia, aplastic anemia, 
thrombocytopenia, eosinophila, decrease in blood count, 
elevated blood pressure, bronchospasm, acute kidney failure, 
blood in urine, kidney injury, increase urination, inflammation 
of bladder, dry eyes and mouth, gum ulcer, inflammation of 
nose

Bupivicaine Hydrochloride: (toxicity most commonly dose 
related from overdosage, rapid absorption from injection site, 
diminished tolerance, or from unintentional intravascular 
injection of local anesthetic) -excitation and/or depression, 
restlessness, anxiety, dizziness, tinnitus, blurred vision, 
tremors, convulsions, drowsiness, unconsciousness, 
respiratory arrest, depression of the myocardium, decreased 
cardiac output, heartblock, hypotension, bradycardia, 
ventricular arrhythmias, cardiac arrest, paralysis of legs, loss of 
consciousness, respiratory paralysis, urinary retention, fecal 
and urinary incontinence, loss of perineal sensation and sexual 
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function, persistent anesthesia, paresthesia, weakness, 
paralysis of lower extremities, loss of sphincter control, 
headache, backache, septic meningitis, meningismus, cranial 
nerve palsies; nausea, vomiting, chills, constriction of the 
pupils; allergic type reactions, 

Bupivicaine Hydrochloride and Epinephrine: see “Bupivicaine 
Hydrochloride” above; allergic-type reactions to sulfites in 
epinephrine-containing solutions 

Fentanyl citrate injection: respiratory depression, apnea, 
rigidity, bradycardia, respiratory arrest, circulatory depression 
or cardiac arrest, hypertension, hypotension, dizziness, 
blurred vision, nausea, emesis, diaphoresis, pruritus, urticarial, 
laryngospasm, anaphylaxis 

Morphine sulfate injection (Duramorph): pruritus, nausea, 
vomiting, constipation, urinary retention, headache, dizziness, 
euphoria, anxiety, hypotension, confusion, reduced male 
potency, decreased libido in men and women, menstrual 
irregularities including amenorrhea, depression of cough 
reflex, interference with thermal regulation, oliguria, 
urticarial, wheals, local tissue irritation, respiratory depression 
and/or respiratory arrest, tolerance, myoclonus, convulsions, 
dysphoric reactions, toxic psychoses, drug abuse and 
dependence; overdosage: respiratory depression with or 
without concomitant CNS depression, apnea, circulatory 
collapse, cardiac arrest 
o
Describe how anticipated risks will be minimized:

The patients will be monitored extensively during anesthesia 
administration and afterwards according to anesthesia protocols and 
will be attached to a continuous monitor and have blood pressure 
and pulse taken according to operating room protocol for regional 
anesthesia. The subjects will be monitored for local anesthetic toxicity 
according to routine anesthesia protocols (monitoring patients for 
symptoms and vital signs). During injection extreme care and caution 
will be used to ensure that the injection in not intravascular by 
aspiration prior to injection. Appropriate interventions for any 
perceived risk will take place. This will be performed in the operating 
room where all resuscitative equipment and personnel (including 
anesthesia physicians) are present. 
o
Document how potential benefits to participants or others justify potential 
risks
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
Benefits of potential decreased postoperative pain above current 
baseline postoperative pain justifies potential risks
o
Describe the plan for data storage and for maintenance of subjects' 
confidentiality

All records will be kept in a secure manner on a secure server 
(Box.com). Access to the records will only be by the listed protocol 
investigators and key personnel and the computer records will be 
password protected. All patients will be assigned a number and all 
information will be recorded under this number - not patient 
identifying information - and a separate list will be kept in a separate 
location under password protection listing medical records of patients 
identified to the code and only researcher Igel will have access to this 
list

Subjects will not be video or audio taped

Data Analysis
o
Appropriate statistical methods will to be used to evaluate study objectives

Hypothesis: The addition of incisional subcutaneous bupivacaine with 
epinephrine to standard spinal anesthesia regimen at the time of 
elective cesarean delivery will decrease postoperative narcotic usage 
by at least 25% in the first 24 hours 

A statement regarding specifically what data are to be used to test 
the hypothesis (or to generate the hypotheses)

Our hypothesis will be tested by assessing cumulative 
postoperative opioid usage in the first 24 hours 
postoperatively 

The statistical method(s) to be used to test the hypothesis with that 
data

Depending on the distribution of the data appropriate 
statistical analysis including one way ANOVA or non-
parametric Kruskal Wallis test will be used to analyze the data. 
Categorical variables such as adverse events, we will be 
analyzed using Chi-Square analysis. Additionally, we will be 
using a linear mixed effects regression analysis to model the 
difference in mean pain scores during the hospital stay. 

A power analysis to determine the sample size 

See above for sample size calculation in Methods section) for 
power analysis
o
Describe methods for interim analyses or early stopping, if applicable

Data Safety Monitoring Board (DSMB) will review interim findings at 
the midpoint of the study. The study will be terminated early if 
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evidence of effect is established, if the intervention appears futile, or 
if harm is established. Specifically, if the p-value of the intervention-
by-time effects based on data accumulated by the midpoint of the 
study is smaller than 0.005 (O’Brien-Fleming boundary), we will 
declare the superiority of the intervention. On the other hand, if the 
upper bound of the 95% confidence interval for the difference 
between the groups is less than 5%, we will declare futility of the 
intervention. The DSMB will also be authorized to recommend early 
termination for other reasons related to patient safety. We will have 
a planned interim analysis halfway through patient recruitment to 
stop the study if there is a significant impact 
o
Describe how possible confounding and/or effect modification will be 
addressed

All patients will be randomized and blinded to their intervention 
groups. Baseline demographic variables will be collected to assess for 
differences among the groups. Patients with a history of chronic pain 
syndromes or chronic opioid use will be excluded from the study.
o
Describe how loss to follow up will be addressed

We will increase the power calculated sample size by 10% to account 
for loss to follow up
Data safety monitoring plan: Patient outcomes will be monitored in real time for side effects 
and patient safety. In order to maintain additional patient safety, a DSMP will be in place for 
the study. The data will be reviewed by two clinicians familiar with spinal anesthesia, cesarean 
birth and perioperative and postoperative management and complications, namely Dr. Yelena 
Spitzer (Obstetric Anesthesia attending) and Dr. Diana Wolfe (Maternal Fetal Medicine 
attending). In addition, clinical researcher Dr. Singh Nair, will review the data. The Data safety 
monitoring committee will meet every 6 months. Minutes of the meetings including 
attendance, a summary of discussion and any relevant findings will be recorded. Data will be 
reviewed for adverse events throughout the study duration. The results of findings and 
recommendations of the team will be reported to the Albert Einstein College of Medicine 
institutional review board for review and action. 
Data quality control and database management.

Describe methods for data entry and data management 
o
All data will be gathered by key personnel member Igel and entered into a 
password protected excel spreadsheet located on a secure Montefiore server 
(Box.com)

Describe the mechanism for checking and editing the data.
o
Data will be checked monthly by randomly selecting patients to check all data 
input by a different key personnel member than originally entered the data

Describe computer data security and subject confidentiality
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o
All records will be kept in a secure manner on a secure server (Box.com) on a 
secure excel spreadsheet with password protection; access to the records will 
only be by the listed protocol investigators and the computer records will be 
password protected; all patients will be assigned a number and all information 
will be recorded under this number - not patient identifying information - and a 
separate list will be kept in a separate location under password protection listing 
medical records of patients identified to the code and only researcher Igel will 
have access to this list

Data given to researchers for future research projects:
o
The de-identified database may be used for future quality improvement and 
research projects. If the database is used for future research projects, it will only 
be available to internal researchers within the Albert Einstein institution. 
Researcher Igel will maintain possession of the database. 
References
1. 
Mkontwana N, Novikova N. Oral analgesia for relieving post-caesarean pain. In: 
Mkontwana N, ed. Cochrane Database of Systematic Reviews. Chichester, UK: John 
Wiley & Sons, Ltd; 2015:CD010450. doi:10.1002/14651858.CD010450.pub2.
2. 
Trabelsi B, Charfi R, Bennasr L, et al. Pharmacokinetics of bupivacaine after bilateral 
ultrasound-guided transversus abdominis plane block following cesarean delivery under 
spinal anesthesia. Int J Obstet Anesth. 2017;32:17-20. doi:10.1016/j.ijoa.2017.04.007.
3. 
Sahmeddini MA, Azemati S, Motlagh EM. Local Infiltration of Tramadol versus 
Bupivacaine for Post Cesarean Section Pain Control: A Double-Blind Randomized Study. 
Iran J Med Sci. 2017;42(3):235-241. http://www.ncbi.nlm.nih.gov/pubmed/28533571. 
Accessed December 18, 2017.
4. 
Tawfik MM, Mohamed YM, Elbadrawi RE, Abdelkhalek M, Mogahed MM, Ezz HM. 
Transversus Abdominis Plane Block Versus Wound Infiltration for Analgesia After 
Cesarean Delivery. Anesth Analg. 2017;124(4):1291-1297. 
doi:10.1213/ANE.0000000000001724.
5. 
Krohg A, Ullensvang K, Rosseland LA, Langesæter E, Sauter AR. The Analgesic Effect 
of Ultrasound-Guided Quadratus Lumborum Block After Cesarean Delivery. Anesth 
Analg. November 2017:1. doi:10.1213/ANE.0000000000002648.
6. 
Kranke P, Jokinen J, Pace NL, et al. Continuous intravenous perioperative lidocaine 
infusion for postoperative pain and recovery. In: Kranke P, ed. Cochrane Database of 
Systematic Reviews. Chichester, UK: John Wiley & Sons, Ltd; 2015:CD009642. 
doi:10.1002/14651858.CD009642.pub2.
7. 
Bensghir M, Elwali A, Miller C, et al. [Effects of skin infiltration with ropivacaine 0,75% 
on postoperative pain after caesarean section]. Gynecol Obstet Fertil. 2008;36(5):516-520. 
doi:10.1016/j.gyobfe.2008.03.007.
8. 
Carvalho B, Clark DJ, Yeomans DC, Angst MS. Continuous Subcutaneous Instillation of 
Bupivacaine Compared to Saline Reduces Interleukin 10 and Increases Substance P in 
Surgical Wounds After Cesarean Delivery. Anesth Analg. 2010;111(6):1452-1459. 
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doi:10.1213/ANE.0b013e3181f579de.
9. 
Corsini T, Cuvillon P, Forgeot A, Chapelle C, Seffert P, Chauleur C. [Single-dose 
intraincisional levobupivacaine infiltration in caesarean postoperative analgesia: a 
placebo-controlled double-blind randomized trial]. Ann Fr Anesth Reanim. 2013;32(1):25-
30. doi:10.1016/j.annfar.2012.10.035.
10. 
Demiraran Y, Albayrak M, Yorulmaz IS, Ozdemir I. Tramadol and levobupivacaine 
wound infiltration at Cesarean delivery for postoperative analgesia. J Anesth. 
2013;27(2):175-179. doi:10.1007/s00540-012-1510-7.
11. 
Eldaba AA, Amr YM, Sobhy RA. Effect of wound infiltration with bupivacaine or lower 
dose bupivacaine/magnesium versus placebo for postoperative analgesia after cesarean 
section. Anesth essays Res. 2013;7(3):336-340. doi:10.4103/0259-1162.123227.
12. 
Ducarme G, Sillou S, Wernet A, et al. [Single-shot ropivacaine wound infiltration during 
cesarean section for postoperative pain relief]. Gynecol Obstet Fertil. 2012;40(1):10-13. 
doi:10.1016/j.gyobfe.2011.07.035.
13. 
Fredman B, Shapiro A, Zohar E, et al. The Analgesic Efficacy of Patient-Controlled 
Ropivacaine Instillation After Cesarean Delivery. Anesth Analg. 2000;91(6):1436-1440. 
doi:10.1097/00000539-200012000-00025.
14. 
Givens VA, Lipscomb GH, Meyer NL. A randomized trial of postoperative wound 
irrigation with local anesthetic for pain after cesarean delivery. Am J Obstet Gynecol. 
2002;186(6):1188-1191. doi:10.1067/mob.2002.122984.
15. 
Jolly C, Jathières F, Keïta H, Jaouen E, Guyot B, Torre A. Cesarean analgesia using 
levobupivacaine continuous wound infiltration: a randomized trial. Eur J Obstet Gynecol 
Reprod Biol. 2015;194:125-130. doi:10.1016/j.ejogrb.2015.08.023.
16. 
Jabalameli M, Safavi M, Honarmand A, Saryazdi H, Moradi D, Kashefi P. The 
comparison of intraincisional injection tramadol, pethidine and bupivacaine on 
postcesarean section pain relief under spinal anesthesia. Adv Biomed Res. 2012;1:53. 
doi:10.4103/2277-9175.100165.
17. 
Kainu JP, Sarvela J, Halonen P, et al. Continuous wound infusion with ropivacaine fails to 
provide adequate analgesia after caesarean section. Int J Obstet Anesth. 2012;21(2):119-
124. doi:10.1016/j.ijoa.2011.12.009.
18. 
Kessous R, Wiznitzer A, Polachek H, et al. Preoperative analgesia with local lidocaine 
infiltration for post cesarean delivery pain management. J Matern Neonatal Med. 
2012;25(7):1131-1134. doi:10.3109/14767058.2011.624222.
19. 
LARSEN KR, KRISTENSEN BB, RASMUSSEN MA, et al. Effect of high-volume 
systematic local infiltration analgesia in Caesarean section: a randomised, placebo-
controlled trial. Acta Anaesthesiol Scand. 2015;59(5):632-639. doi:10.1111/aas.12509.
20. 
Bamigboye AA, Hofmeyr GJ. Local anaesthetic wound infiltration and abdominal nerves 
block during caesarean section for postoperative pain relief. Cochrane Database Syst Rev. 
2009;(3):CD006954. doi:10.1002/14651858.CD006954.pub2.
21. 
Adesope O, Ituk U, Habib AS. Local anaesthetic wound infiltration for postcaesarean 
section analgesia. Eur J Anaesthesiol. 2016;33(10):731-742. 
doi:10.1097/EJA.0000000000000462.
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22. 
Tharwat AA, Yehia AH, Wahba KA, G. Ali A-E. Efficacy and safety of post-cesarean 
section incisional infiltration with lidocaine and epinephrine versus lidocaine alone in 
reducing postoperative pain: A randomized controlled double-blinded clinical trial. J 
Turkish Ger Gynecol Assoc. 2016;17(1):1-5. doi:10.5152/jtgga.2015.0185.
IRB NUMBER: 2017-8094
IRB APPROVAL DATE: 07/11/2018

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ALBERT EINSTEIN COLLEGE OF MEDICINE 
MONTEFIORE MEDICAL CENTER
DOCUMENTATION OF INFORMED CONSENT AND HIPAA AUTHORIZATION
Introduction
You are being asked to participate in a research study called “Efficacy of incisional infiltration 
with local anesthetic during elective cesarean delivery for postoperative pain control: a 
randomized controlled 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.” His name is Dr. Jeffrey 
Bernstein. 
You can reach Dr. Bernstein at: 
Office Address: 
Jack D. Weiler Hospital 
1825 Eastchester Road 
Bronx, NY 10461
Telephone #: 718.904.2872 
For questions about the research study, or if you 
believe you have an injury, contact the Principal 
Investigator or the IRB.
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
Concise Summary
The purpose of our study is to determine if giving an injection of numbing medication at the 
incision at the end of your cesarean will help control your pain AFTER your cesarean delivery. 
The information we learn by doing this study may help us determine the best pain medication for 
cesarean deliveries. 
Depending upon if you enroll in this study, you will be receiving the usual regimen of pain 
medication in your spinal anesthesia. At the end of your cesarean delivery, while you are still 
under the spinal medication, you will receive an injection at the incision of either numbing 
medication or sterile saline. After your cesarean delivery you will receive pain medications by 
mouth commonly given after a cesarean delivery. You will only be in the study during your 
hospital stay. You will also be asked multiple times during your stay by nursing, doctors, and 
anesthesia about your pain control. Benefits to you include improved pain control after your 
cesarean. 
The greatest risk to participating in this study is that you will be randomized to one of three 
injections at the site of your incision- meaning that you and your doctor will not be able to 
choose which medication you receive. There is a risk of allergic reaction to any medication you 
are given. There is a small risk of systemic toxicity with the numbing medication. The most 
common risks of opioids (oxycodone) include nausea/ vomiting/ constipation. 
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We do not know which regimen is best for pain control AFTER your cesarean delivery which is 
why we are doing this study. 
If you are interested in learning more about this study, please continue reading below.
 
Why is this study being done? 
The goal of this study is to determine if adding a local injection of numbing medication during 
your cesarean delivery will be better at controlling your pain AFTER your cesarean delivery so 
that you will need less narcotic pain medication. 
The U.S. Food and Drug Administration (FDA) has approved bupivicaine as an anesthetic and 
for pain but the FDA has not approved bupivicaine to be given specifically for postoperative 
cesarean pain. 
Acetaminophen and oxycodone are being used as part of routine clinical care for pain control 
after your cesarean. Fentanyl and duramorph are being used in your spinal anesthesia and are 
FDA approved for regional anesthesia and used for this purpose in routine clinical care. 
Why am I being asked to participate? 
You are being asked to participate in this study because you are going to have a cesarean 
delivery under spinal anesthesia at Albert Einstein College of Medicine- Weiler or Wakefield 
Divisions. 
How many people will take part in the research study?
You will be one of about 276 women who will be participating in this study. 
How long will I take part in this research?
You will be in the study for the remainder of your hospital stay after your cesarean delivery. You 
will not need to make any other visits, participate in any telephone calls, or any communication 
after your hospital stay to participate in this study. 
What will happen if I participate in the study?  
Depending upon if you enroll in this study, you will be receiving the common regimen of 
medications commonly given in your spinal during your cesarean delivery and possibly an 
injection at your incision of a local numbing medication. You will not know which medications 
you received during the study. The remainder of your care during your cesarean delivery will be 
the same as anyone getting a cesarean delivery in the hospital. After your cesarean delivery 
you will receive pain medications we usually give women after a cesarean delivery.  These 
medications are oxycodone (an opioid/ narcotic) and acetaminophen (or more commonly known 
as Tylenol). These medications will be given to you “PRN” meaning that you will only get the 
medication if you are in pain and ask for it. Your nurse will ask you about your pain on a pain 
scale every few hours, but you can ask for pain medication at any time you need it. If you need 
more pain medication on top of what you are receiving in the study to control your pain, you may 
ask your nurse and she will ask the covering doctor. You will remain in the study for the 
IRB NUMBER: 2017-8094
IRB APPROVAL DATE: 05/18/2018
IRB EXPIRATION DATE: 03/13/2019


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remainder of your hospital stay. You will be asked during the study about your satisfaction with 
your pain control. You will not be contacted after you leave the hospital about the study.
This study will not include any blood draws or tissue samples above what will be ordered by 
your treating physicians/ care team to care for you routinely during your cesarean delivery. 
If you are eligible for the study, we will assign you by chance (like a coin toss) to one of three 
groups: under the skin injection of sterile saline group, under the skin injection of bupivacaine 
group or under the skin injection of bupivacaine + epinephrine group.  You and the study doctor 
cannot choose your study group.  You will have a 1 in 3 chance of being assigned to any of the 
groups.
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. At most, the Web site will 
include a summary of the results. You can search this Web site at any time.
As part of this study we will review your medical records and put the information we collect in 
our research records. No information will be collected that could later be used to identify you. 
Genetic Testing 
This study will not involve genetic research or genetic testing. 
Information Banking (Future Use and Storage)
We will store information about you in a “bank”, which is a library of information from many 
studies. This information cannot 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. Your information may be kept for a long time, perhaps longer than 
50 years. 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 databases. These may 
include databases maintained by the federal government.
You can choose not to participate in the bank and still be part of the main study and this will not 
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.
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.
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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 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. Jeffrey Bernstein 718-904-2872
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. 

Drugs may cause a reaction that, if not treated promptly, could be life-threatening.  
It is important that you report all symptoms, reactions and other complaints to the 
research study doctor. 

You may carry out all your normal postoperative activities.
Confidentiality
We will keep your information confidential. Your research records will be kept confidential and 
your name will not be used in any written or verbal reports. Your information will be given a code 
number and separated from your name or any other information that could identify you. The 
form that links your name to the code number will be kept in a secure manner and only the 
investigator and study staff will have access to the file. All information will be kept in a secure 
manner and computer records will be password protected. Your study information will be kept 
as long as they are useful for this research.
Information about your participation in this study will be entered into your Electronic Medical 
Record (EMR). Once placed in your EMR, the information will be available to all of your 
providers who participate in the EMR system. The purpose of this entry is to provide research 
information that has the potential to impact your medical care.
The only people who can see your research records are:

the research team and staff who work with them
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
groups that review research (the Einstein IRB and the Office for Human Research 
Protections)
These people who receive your health information, may not be required by privacy laws to 
protect it and may share your information with others without your permission, if permitted by 
laws governing them.  All of these groups have been asked to keep your information 
confidential.
Are there any risks to me? 
A risk of taking part in this study is the possibility of a loss of confidentiality or privacy. Loss of 
privacy means having your personal information shared with someone who is not on the study 
team and was not supposed to see or know about your information. The study team plans to 
protect your privacy – see the Confidentiality section above for details. You will be asked 
multiple times during your hospital stay. You may feel uncomfortable answering questions about 
your pain. You can choose not to answer questions that make you feel uncomfortable. Risks of 
a local skin injection include redness, pain, infection, and allergy.
Risks of Taking Opioids
The medications that you receive during this study may cause drowsiness or sedation.  You 
should not drive after receiving these medications. They may also lead to abuse or addiction if 
misused. 
Risks of taking: Oxycodone

Common side effects: constipation, nausea, vomiting, sleepiness, itching, dry mouth, 
sweating, weakness

Less common side effects: loss of appetite, nervousness, inability to sleep, fever, 
confusion, diarrhea, abdominal pain, upset stomach, rash, anxiety, shortness of breath, 
chills, abnormal dreams, thought abnormalities, hiccups, twitching

Rare side effects: enlarged lymph nodes, heart racing, ear ringing, abnormal vision, 
difficult swallowing, gas, mouth sores, chest pain, swelling, pain, thirst, withdrawal 
syndrome, allergic reaction, throat irritation, confusion, seizures, increased liver function 
tests, dehydration, seizures, fainting, tremor, agitation, feeling disconnected or detached 
from one's body and thoughts, difficulty remembering, headaches, cough, decreased 
libido, hallucination, trouble and pain urinating, dry skin, changes in voice, seizures, 
decreased muscle tone, prickling sensations, changes in taste
Risks of taking: Acetaminophen

Common side effects: nausea, vomiting, headache

Less common side effects: anemia, fatigue, swelling, increased liver function tests, 
difficulty sleeping, fever

Rare side effects: breath sounds abnormal, weakness, fatigue, muscle cramping, 
constipation, muscle spasms, lockjaw, anxiety, shortness of breath, high or low blood 
pressure, lockjaw
Risks of taking: Bupivicaine Hydrochloride (Marcaine)

Toxicity most commonly dose related from overdosage or incorrect administration

Common side effects: numbness, headache, backache

Less common side effects: excitation and/or depression, restlessness, anxiety, 
dizziness, ringing in ears, blurred vision, drowsiness, nausea, vomiting, chills, 
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constriction of the pupils, difficulty breathing, swelling, hives, rash, decreased blood 
pressure

Rare side effects: tremors, convulsions, unconsciousness, difficulty breathing, heart 
attack, changes in heartbeat or rhythm, paralysis of legs, loss of consciousness, difficulty 
breathing, inability to urinate, loss of urine or feces, numbness of the perineum, and 
sexual function, longer than expected numbness, prickling sensations, weakness, 
paralysis of lower extremities, infection or inflammation or the spinal membranes, cranial 
nerve issues
Risks of taking: Bupivicaine Hydrochloride and Epinephrine: see “Bupivicaine Hydrochloride” 
above; difficulty breathing, swelling, hives or rash to sulfites in epinephrine-containing solutions 
Risks of taking: Fentanyl citrate injection

Common side effects: nausea, vomiting, dizziness, sweating, itching

Less common side effects: high or low blood pressure, slowing of heart beat, blurred 
vision, allergic reaction

Rare side effects: difficult breathing or breathing failure, heart failure
Risks of taking: Morphine sulfate injection (Duramorph)

Common side effects: itching, nausea, vomiting, constipation

Less common side effects: difficulty urinating, headache, dizziness, sense of happiness 
or unhappiness, anxiety, decreased blood pressure, confusion, decreased libido, 
menstrual irregularities, depression of cough reflex, interference with temperature 
regulation, decreased urination, muscle spasm or twitching, difficulty breathing, swelling, 
hives, rash

Rare side effects: convulsions, difficulty breathing or breathing failure
There may be other risks of any drug that are currently unknown.
Risks to Women Who Are Pregnant/ Breastfeeding
All medications used in this study are medications commonly used and given to pregnant 
women at the time of their cesarean delivery or after their cesarean delivery for pain control. 
Allergic Reaction to Study Drug
Any drug can cause an allergic reaction which could be mild or more serious and can even 
result in death.  Common symptoms of an allergic reaction are rash, itching, skin problems, 
swelling of the face and throat, or trouble breathing.  If you are having trouble breathing, tell the 
treating physician in the hospital immediately.
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 improved pain control after your cesarean delivery.
We hope you will participate because the study will generate important information about 
postoperative pain control after cesarean deliveries. 
IRB NUMBER: 2017-8094
IRB APPROVAL DATE: 05/18/2018
IRB EXPIRATION DATE: 03/13/2019


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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 he 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: 2017-8094
IRB APPROVAL DATE: 05/18/2018
IRB EXPIRATION DATE: 03/13/2019