Clinical trial NCT03695172
Conditions: Pain, Postoperative Cesarean Section
Sponsor: Duke University
Start date: 2019-09-12; Completion date: 2021-03-20
Enrollment: 12 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this prospective single center, randomized study is to determine if ultrasound guided Transversus Abdominis Plane (TAP), Quadratus Lumborum (QL), and Erector Spinae Plane (ESP) blocks decrease opioid consumption in subjects undergoing elective cesarean section.

Detailed description:
The typical anesthetic for cesarean section at Duke University Hospital includes a spinal or combined spinal epidural anesthetic with intrathecal dosing of 1.4-1.6 mL bupivacaine HCl 0.75%, 15 mcg fentanyl, and 150 mcg morphine. If the epidural component of a combined spinal epidural anesthetic is used, the subject will be withdrawn from the study. Patients also receive rectal acetaminophen 975 mg prior to incision; intravenous (IV) ondansetron 4 mg, IV metoclopramide 10 mg, IV famotidine 20 mg and IV dexamethasone 4 mg intraoperatively; and IV ketorolac 15 mg prior to skin closure. There will be no change to this typical practice.

Patients who consent to be in this study will be randomized to receive one of three truncal nerve blocks using an online randomization program by the study PI (AK/EG): (1) ultrasound-guided bilateral classic TAP block; (2) ultrasound-guided bilateral anterior QL (also known as transmuscular or QL type 3) block; (3) ultrasound-guided bilateral ESP block at the level of T9. These nerve blocks will be performed after delivery and within one hour of skin closure with 25 mL of 0.2% ropivacaine with epinephrine 1:400,000 per side. Nerve blocks will be performed by a dedicated and trained group of regional anesthesiologists. This non-blinded regional anesthesiologist will save an ultrasound image after local anesthetic administration while the needle is still in position on each side. The study team will review these images to ensure a high quality of block performance.

Patients will have standard postoperative pain medication orders, including acetaminophen 975 mg PO Q6H for 4 days (scheduled, starting 6 hours after intraoperative rectal dose), ketorolac 15 mg IV Q6H for 24 hours (scheduled, starting 6 hours after intraoperative dose), ibuprofen 600 mg PO Q6H for 3 days (scheduled, starting 24 hours after first dose of ketorolac) and oxycodone 5-10mg PO Q3-4H PRN for 4 days. If patients are unable to tolerate oral medication or oxycodone is insufficient, rescue medications may be ordered: IV morphine 1-2 mg or IV hydromorphone 0.3-0.5 mg Q4H as needed. There is no change from the standard postoperative order sets used for patients after cesarean section.

Subjects' verbal pain scores at rest and with movement as well as opioid consumption will be recorded at 2, 6, 24, and 48 hours postoperatively. Additionally, the amount of antiemetics and antipruritics used will also be recorded at the above time points. These scores will be entered into a Duke University Hospital REDCap database. Subjects will also be sent a survey assessing their satisfaction with pain control one week after discharge via email or telephone. This information will be collected via Duke University Hospital REDCap.

Arms: arm 1: Patients will receive bilateral TAP blocks after delivery and within one hour of skin closure with 25 mL of 0.2% ropivacaine with epinephrine 1:400,000 per side. arm 2: Patients will receive bilateral QL blocks after delivery and within one hour of skin closure with 25 mL of 0.2% ropivacaine with epinephrine 1:400,000 per side. arm 3: Patients will receive bilateral ESP blocks after delivery and within one hour of skin closure with 25 mL of 0.2% ropivacaine with epinephrine 1:400,000 per side.
Interventions: intervention 1: Ropivacaine intervention 2: TAP block intervention 3: QL block intervention 4: ESP block
Intervention descriptions: intervention 1: Patients will be randomly assigned to receive one three blocks (TAP, QL, ESP)after delivery of baby with ropivicaine intervention 2: Patient will receive bilateral TAP blocks after delivery and within one hour of skin closure with 25 mL of 0.2% ropivacaine with epinephrine 1:400,000 per side. intervention 3: Patients will receive bilateral QL blocks after delivery and within one hour of skin closure with 25 mL of 0.2% ropivacaine with epinephrine 1:400,000 per side. intervention 4: Patients will receive bilateral ESP blocks after delivery and within one hour of skin closure with 25 mL of 0.2% of ropivacaine with epinephrine 1:400,000 per side.

Protocol documents:
Prot_SAP_000.pdf: 
Research Summary Version Date: 8/27/2018 
Protocol ID: Pro00100742 
Research Summary 
 
1.  Protocol Title:  
Comparison of TAP, Anterior QL, or ESP Block for Elective Cesarean Section 
 
2.  Purpose of the Study:  
The purpose of this prospective single center, randomized study is to determine if ultrasound guided 
Quadratus Lumborum (QL) and Erector Spinae Plane (ESP) blocks decrease opioid consumption 
compared to Transversus Abdominis Plane (TAP) in subjects undergoing elective cesarean section. Total 
opioid consumption and pain scores will be monitored for 48 hours postoperatively.  
 
3.  Background & Significance:  
Cesarean section is an invasive surgery that can lead to significant postoperative pain. Well controlled 
postoperative pain in this specific patient population can help minimize the effect of surgery on a new 
mother’s ability to care for her newborn and ease the transition back home, as well as allay any concerns 
regarding transfer of opiates through breastfeeding.  
 
The typical anesthetic plan involves a spinal anesthetic or combined spinal epidural anesthetic as the 
primary anesthetic for the procedure followed by a combination of oral pain medications, including 
opioids, to control pain postoperatively. Side effects from opioid use, including nausea, vomiting, 
sedation, or respiratory depression, can hinder a new mother’s ability to fully participate in the care of her 
newborn. Additionally, some women are leery to take opioids if they are breastfeeding for fear of transfer 
to their newborn [1]. Despite widespread postoperative prescription of opioids, women report poor pain 
control after cesarean section [2-4]. As part of a larger public health concern, unused postoperative 
opioids can be detrimental and the possibility of persistent opioid use after surgery is feasible in this 
patient population [5].  
 
TAP blocks have been utilized for years to help control incisional pain after abdominal surgeries, including 
cesarean section [6, 7]. However, it is not without limitations and there is some question regarding efficacy 
[8]. TAP blocks often decrease somatic pain, but do not impact visceral pain which can contribute to 
uncontrolled postoperative pain after cesarean section. Additionally, it has been shown that TAP blocks 
do not improve analgesia when patients are already receiving intrathecal morphine[9]. 
 
With newer truncal blocks like anterior quadratus lumborum (QL) and erector spinae plane (ESP) blocks 
coming into practice, it will be helpful to identify which, if any, of the three blocks can benefit this unique 
patient population.  
 
Studies involving earlier variations of the quadratus lumborum block have shown to be successful after 
cesarean section [10, 11]. At Duke University Hospital, we most commonly perform the anterior variation 
of the QL block which has not specifically been studied in this patient population. However, case series 
have demonstrated success in other abdominal procedures [12].  
 


Research Summary Version Date: 8/27/2018 
Protocol ID: Pro00100742 
Erector spinae plane blocks were initially used to treat pain from rib fractures and thoracotomies, but 
have now been shown to be effective for open abdominal procedures [13-15]. However, there has only 
been one case report to date using an ESP block for cesarean section [16].  
 
This study aims to answer if QL or ESP can impact postoperative opioid use and pain scores after 
cesarean section compared to TAP block.  
 
4.  Design & Procedures:  
 
  
The typical anesthetic for cesarean section at Duke University Hospital includes a spinal or combined 
spinal epidural anesthetic with intrathecal dosing of 1.4-1.6 mL bupivacaine HCl 0.75%, 15 mcg fentanyl, 
and 150 mcg morphine. If the epidural component of a combined spinal epidural anesthetic is used, the 
subject will be withdrawn from the study. Patients also receive rectal acetaminophen 975 mg prior to 
incision, intravenous (IV) ondansetron 4 mg, metoclopramiden10 mg, famotidine 20 mg and 
dexamethasone 4 mg intraoperatively, and IV ketorolac 15 mg prior to skin closure. There will be no 
change to this typical practice.    
  
Patients who consent to be in this study will be randomized to receive one of three truncal nerve blocks 
using an online randomization program by the study PI (AK/LG): (1) ultrasound-guided bilateral classic 
TAP block; (2) ultrasound-guided bilateral anterior QL (also known as transmuscular or QL type 3) block; 
(3) ultrasound-guided bilateral ESP block at the level of T9. These nerve blocks will be performed after 
delivery and within one hour of skin closure with 25 mL of 0.2% ropivacaine with epinephrine 1:400,000 
per side. Nerve blocks will be performed by a dedicated and trained group of regional anesthesiologists. 
This non-blinded regional anesthesiologist will save an ultrasound image after local anesthetic 
administration while the needle is still in position on each side. The study team will review these images 
to ensure a high quality of block performance.  
 
Patients will have standard postoperative pain medication orders, including acetaminophen 975 mg PO 
Q6H for 4 days (scheduled, starting 6 hours after intraoperative rectal dose), ketorolac 15 mg IV Q6H for 
24 hours (scheduled, starting 6 hours after intraoperative dose), ibuprofen 600 mg PO Q6H for 3 days 
(scheduled, starting 24 hours after first dose of ketorolac) and oxycodone 5-10mg PO Q3-4H PRN for 4 
days. If patients are unable to tolerate oral medication or oxycodone is insufficient, rescue medications 
may be ordered: IV morphine 1-2 mg or IV hydromorphone 0.3-0.5 mg Q4H as needed. There is no 
change from the standard postoperative order sets used for patients after cesarean section.  
 
Subjects’ verbal pain scores at rest and with movement as well as opioid consumption will be recorded 
at 2, 6, 24, and 48 hours postoperatively. The validated Obstetric Quality of Recovery-11 (ObsQoR-11) 
score will also be assessed at 24 and 48 hours postoperatively [17]. Additionally, the amount of 
antiemetics and antipruritics used will also be recorded at the above time points. These scores will be 
entered into a Duke University Hospital REDCap database. Subjects will also be sent a survey assessing 
their satisfaction with pain control one week after discharge via email or telephone. This information will 
be collected via Duke University Hospital REDCap.   
 
5.  Selection of Subjects: 


Research Summary Version Date: 8/27/2018 
Protocol ID: Pro00100742 
 
Patients undergoing elective cesarean section will be identified the day prior to surgery. Patients will be 
contacted via telephone by a member of the study team the day prior to surgery to confirm eligibility and, 
if eligible and interested, the study will be explained. Inclusion and exclusion criteria will be assessed 
through self-reporting by the subjects and review of patient chart on EPIC. Patients will be given the 
opportunity to ask initial questions about the study over the phone. Patients interested in participating will 
have the protocol fully explained and written informed consent will be obtained on the day of surgery prior 
to the procedure. The patient's care team, including attending surgeons, attending anesthesiologists, 
anesthesia residents, and nurse anesthetists will be informed of the patient's inclusion via secure email 
with specifics for the case. 
 
Inclusion Criteria: 
1) American Society of Anesthesiologists (ASA) Physical Status 1-3 
2) Age greater than or equal to 18 years 
3) Scheduled cesarean section 
4) English speaking 
 
Exclusion Criteria: 
1) ASA Physical Status 4-5 
2) Diagnosis of chronic pain  
3) Chronic opioid use (opioid use in the past 3 months) 
4) Preoperative use of SSRIs (Celexa, Lexapro, Prozac, Paxil), SNRIs (Cymbalta, Effexor), 
gabapentin, or pregabalin (Lyrica) 
5) Inability to cooperate with or understand protocol 
6) Inability to communicate pain scores or need for analgesia 
7) Infection at the site of block placement 
8) Intolerance or allergy to local anesthetics 
9) Neurologic deficit or disorder 
10) Blood thinning disorder or taking anticoagulant medication 
11) BMI > 50 kg/m2 
12) Suspected or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol 
within the past 2 years 
13) Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the 
investigator, may interfere with study assessments or compliance 
14) Current or historical evidence of any clinically significant disease or condition that, in the opinion 
of the investigator, may increase the risk of surgery or complicate the subject’s postoperative 
course 
 
6.  Subject Recruitment & Compensation: 
Only patients who are having elective cesarean sections are eligible for this study. We will not bias any 
demographic groups in identifying patients eligible for this study. A total of 75 patients will be consented 
from Duke University Hospital. An IRB approved phone script will be used to discuss the study with 
eligible patients. Patients will not receive any additional compensation for enrollment in this study. 


Research Summary Version Date: 8/27/2018 
Protocol ID: Pro00100742 
 
7.  Consent Process: 
Potential subjects will be contacted and screened the day prior to surgery via telephone. If the patient is 
interested in the study, the consent process will take place in a private preoperative room on the Labor 
and Delivery ward prior to surgery. The consent process will be conducted by a member of the research 
team. Throughout the consent process, measures will be taken to maintain privacy, such as conducting 
face-to-face conversations in private rooms. As much time as necessary will be spent with each potential 
subject to sufficiently explain and answer all questions, and address all concerns they may have in regard 
to the study and/or consent process.  Under HIPAA waiver, the study team will identify potential subjects 
from clinic schedules, OR schedules, and Maestro Care. 
 
8.  Subject’s Capacity to Give Legally Effective Consent: 
Patients who do not have the capacity to give legally effective consent will not be approached for 
participation in this study.  
 
9.  Study Interventions: 
See 4 above. 
 
10. Risk/Benefit Assessment: 
Patients will be consented regarding the standard risks associated with regional anesthesia. These 
standard risks include: minor pain or discomfort; bruising; infection at the needle insertion site; injury to 
arteries, veins, or nerves affecting the abdomen, back, or legs; residual numbness, weakness, or 
paralysis; headache; muscle soreness. If patients are allergic to the local anesthetic (ropivacaine) or have 
an adverse drug reaction, they could possibly have a reaction that is severe enough to cause cardiac 
arrest and/or respiratory arrest. If there is injection of local anesthetic into a blood vessel, patients could 
possibly have loss of consciousness, seizure, or cardiac arrest. 
 
There have been rare case reports of hip or knee weakness after quadratus lumborum block. Therefore, 
patients will be encouraged to have someone with them to help them of bed the first time after the nerve 
block is performed. 
 
Benefits include contributing to general knowledge to improve future patient care.  Benefits also include 
potential analgesic benefit, decreased pain scores, and improved patient satisfaction.  Conversely, this 
study may show no benefit of the block, thereby invalidating the technique. 
 
11. Costs to the Subject: 
Subjects will not incur any additional costs to participate in the study.  A MaestroCare build will be created 
to ensure that any subjects are not charged for researched related procedures, equipment, or 
medications. 
 
12. Data Analysis & Statistical Considerations: 
A randomized trial of 75 subjects (25 per group) will provide 80% power to detect a 35% decrease in 
opioid use between treatment groups in a t-test at an alpha level 0.017 utilizing Bonferroni’s correction, 


Research Summary Version Date: 8/27/2018 
Protocol ID: Pro00100742 
(parametric), Mann-Whitney U Test (nonparametric), or repeated measures ANOVA as appropriate. 
Sample size and power calculations were performed using PASS v15 (NCSS, LLC. Kaysville, Utah). 
 
Patient and surgical characteristics will be summarized by standard descriptive statistics and will be 
compared between groups using t-tests, ANOVA, or Wilcoxon sum ranked tests as appropriate. We will 
report odds ratios, 95% confidence intervals, and p-values to assess significance and clinical importance 
of the observed treatment effect.  Additional measures of treatment efficacy (pain scores, ease of 
mobility, overall pain experience) will be summarized overall and between groups to further characterize 
the treatment effect in this population.   
 
 
13. Data & Safety Monitoring:  
In accordance with federal regulations the PI will monitor for, review, and promptly report to the IRB, 
appropriate institutional officials, sponsor, coordinating center and the appropriate regulatory agency 
head all unanticipated problems involving risks to subjects or others that occur in the course of a subject’s 
participation in a research study (45 CFR 46.103(b)(5)(i) and 21 CFR 56.108(b)(1)), all AE reports will be 
reported per the DUHS IRB policies. PI will be monitoring all AEs and submitting reports to the IRB per 
DUHS IRB policy. 
 
14. Privacy, Data Storage & Confidentiality: 
Potential subjects and their families will be approached in private rooms. Any guests not involved in the 
consent process will be asked to leave the room during any such communications, unless the patient 
allows them to be present.  Efforts to maintain subject confidentiality will include following Federal Privacy 
Regulations which provide safeguards for privacy, security, and authorized access. Except when required 
by law, subjects will not be identified by name, social security number, address, telephone number, or 
any other direct personal identifier in study records disclosed outside of Duke University Health System 
(DUHS).  Subjects will not be revealed in any reports or publications resulting from this study.   For 
records disclosed outside of DUHS, subjects will be assigned a unique code number. The paper and 
electronic data will be stored as per the RDSP. 
 
15. References: 
1. 
Marcus, M.A. and G. Brodner, Are opioids contraindicated as postoperative pain relief for patients who 
are breast-feeding their newborn? Curr Opin Anaesthesiol, 2001. 14(3): p. 287-9. 
2. 
Marcus, H., et al., Quality of pain treatment after caesarean section: Results of a multicentre cohort 
study. Eur J Pain, 2015. 19(7): p. 929-39. 
3. 
Bateman, B.T., et al., Patterns of Opioid Prescription and Use After Cesarean Delivery. Obstet Gynecol, 
2017. 130(1): p. 29-35. 
4. 
Osmundson, S.S., et al., Postdischarge Opioid Use After Cesarean Delivery. Obstet Gynecol, 2017. 130(1): 
p. 36-41. 
5. 
Bateman, B.T., et al., Persistent opioid use following cesarean delivery: patterns and predictors among 
opioid-naive women. Am J Obstet Gynecol, 2016. 215(3): p. 353 e1-353 e18. 
6. 
Eslamian, L., et al., Transversus abdominis plane block reduces postoperative pain intensity and analgesic 
consumption in elective cesarean delivery under general anesthesia. J Anesth, 2012. 26(3): p. 334-8. 
7. 
Fusco, P., et al., Transversus abdominis plane block for analgesia after Cesarean delivery. A systematic 
review. Minerva Anestesiol, 2015. 81(2): p. 195-204. 


Research Summary Version Date: 8/27/2018 
Protocol ID: Pro00100742 
8. 
Factor, D. and K.J. Chin, Transversus abdominis plane block in lower segment cesarean section: a 
question of block failure or lack of efficacy? Reg Anesth Pain Med, 2010. 35(4): p. 404-5. 
9. 
Kanazi, G.E., et al., The analgesic efficacy of subarachnoid morphine in comparison with ultrasound-
guided transversus abdominis plane block after cesarean delivery: a randomized controlled trial. Anesth 
Analg, 2010. 111(2): p. 475-81. 
10. 
Blanco, R., et al., Quadratus Lumborum Block Versus Transversus Abdominis Plane Block for 
Postoperative Pain After Cesarean Delivery: A Randomized Controlled Trial. Reg Anesth Pain Med, 2016. 
41(6): p. 757-762. 
11. 
Kadam, V.R., Ultrasound guided quadratus lumborum block or posterior transversus abdominis plane 
block catheter infusion as a postoperative analgesic technique for abdominal surgery. J Anaesthesiol Clin 
Pharmacol, 2015. 31(1): p. 130-1. 
12. 
Kadam, V.R. and S. Howell, Ultrasound-guided continuous transmuscular quadratus lumborum block- L4 
or L2 level catheter insertion for analgesia in open abdominal surgery: Case series. Indian J Anaesth, 
2018. 62(7): p. 555-557. 
13. 
Chin, K.J., L. Malhas, and A. Perlas, The Erector Spinae Plane Block Provides Visceral Abdominal Analgesia 
in Bariatric Surgery: A Report of 3 Cases. Reg Anesth Pain Med, 2017. 42(3): p. 372-376. 
14. 
Luis-Navarro, J.C., et al., Erector spinae plane block in abdominal surgery: Case series. Indian J Anaesth, 
2018. 62(7): p. 549-554. 
15. 
Tulgar, S., O. Selvi, and M.S. Kapakli, Erector Spinae Plane Block for Different Laparoscopic Abdominal 
Surgeries: Case Series. Case Rep Anesthesiol, 2018. 2018: p. 3947281. 
16. 
Yamak Altinpulluk, E., D. Garcia Simon, and M. Fajardo-Perez, Erector spinae plane block for analgesia 
after lower segment caesarean section: Case report. Rev Esp Anestesiol Reanim, 2018. 65(5): p. 284-286. 
17.  
Ciechanowicz, S., et al., Development and evaluation of an obstetric quality-of-recovery score (ObsQoR-
11) after elective Caesarean delivery. British Journal of Anaesthesia, 2019, 122 (1): 69-78. 
 
 

ICF_001.pdf: 
Consent to Participate in a Research Study
Comparison of TAP, Anterior QL, or ESP 
Block for Elective Cesarean Section 
Page 1 of 7                                                  Subject*Initials:______________
DUKE UNIVERSITY HEALTH SYSTEM
Form
M0345
Concise Summary
This is a research study to find out if injection of numbing medication (local anesthetic) in one of three 
different locations (either in your abdomen or back) will help to decrease your need for pain medication 
after cesarean section.
If you enroll in this study, you will be randomized to receive a nerve block, or an injection of local 
anesthetic (numbing medication) in one of three specific locations in your abdomen or back. This 
injection will take place after your baby has been delivered at the end of your surgery. We will be 
evaluating how this injection impacts the amount of strong narcotic pain medication, such as oxycodone, 
medication you need to control your pain after surgery. We believe these injections have the potential to 
decrease the amount of strong narcotic pain medication you will need after surgery and improve your 
pain management. The rest of your anesthesia care, including your spinal anesthesia and postoperative 
pain medication, will be the same as it would be without participating in the study. You will be enrolled 
in this study for 48 hours.
The risks of this study are described in this document.  Some risks include: minor pain or discomfort; 
infection at the needle insertion site; injury to arteries, veins, or nerves affecting the abdomen, back, or 
legs; residual numbness, weakness, or paralysis; reaction to numbing medication.
If you are interested in learning more about this study, please read continue reading below.
You are being asked to take part in this research study because you are scheduled for an elective 
cesarean section. Research studies are voluntary and include only people who choose to take part. Please 
read this consent form carefully and take your time making your decision. As your study doctor or study 
staff discusses this consent form with you, please ask him/her to explain any words or information that 
you do not clearly understand. We encourage you to talk with your family and friends before you decide 
to take part in this research study. The nature of the study, risks, inconveniences, discomforts, and other 
important information about the study are listed below.
Please tell the study doctor or study staff if you are taking part in another research study.
Amanda Kumar, MD, will conduct the study and it is funded by the Duke University Hospital 
Department of Anesthesiology.
WHO WILL BE MY DOCTOR ON THIS STUDY?
If you decide to participate, Dr. Kumar will be your doctor for the study and will be in contact with your 
regular health care provider throughout the time that you are in the study and afterwards, if needed.
WHY IS THIS STUDY BEING DONE?
The purpose of this study is to learn if injecting a numbing medication (local anesthetic) in one of three 
DUHS IRB
IRB NUMBER: Pro00100742
IRB REFERENCE DATE: 01/13/2020
IRB EXPIRATION DATE: 01/23/2021


Consent to Participate in a Research Study
Comparison of TAP, Anterior QL, or ESP 
Block for Elective Cesarean Section 
Page 2 of 7                                                  Subject*Initials:______________
DUKE UNIVERSITY HEALTH SYSTEM
Form
M0345
locations (close to nerves in either your abdomen or back) will help to decrease your need for pain 
medication after your cesarean section. Strong narcotic medications, such as oxycodone, are often 
prescribed after cesarean section as part of a pain regimen. However, many people experience side 
effects from narcotics including nausea, vomiting, constipation, or sedation. These injections (nerve 
blocks) have been shown to decrease narcotic use after other abdominal and thoracic surgeries, but no 
studies have specifically looked at the benefit after cesarean section.
HOW MANY PEOPLE WILL TAKE PART IN THIS STUDY?
This is a single institution study, meaning that it is only being performed at Duke University Hospital. 
Seventy-five (75) subjects will take part in this study at Duke University Hospital.
WHAT ARE MY RESPONSIBILITIES DURING THE STUDY?
Being in this study, it is important that you:

Tell the study doctor about your medical and medication history;

Tell your doctor and/or study team your pain scores during your hospitalization;

Report any possible side effects, such as leg weakness or irritation around the injection site to 
your doctor and/or study team.
WHAT IS INVOLVED IN THE STUDY?
If you agree to be in this study, you will be asked to sign and date this consent form. If you do not sign
this consent form, you will continue to receive your regular care, but not as a part of this study.
To participate in this study, you must be medically able to undergo a nerve block. Be sure to report to 
the study team if you have any medical conditions, infections, or allergies. You will not be eligible for 
this trial if you have a history of allergy to local anesthetics (such as lidocaine or Novocain), have a 
blood thinning disorder (such as hemophilia or von Willebrand disease), are taking blood thinners (such 
as heparin), or have a condition that would make it difficult for you to communicate with your doctor. 
The typical anesthetic plan for elective cesarean section at Duke University Hospital is for patients to 
receive a spinal anesthetic or a combined spinal epidural anesthetic in the operating room immediately 
before surgery, which will numb your abdomen and legs. It is standard for patients to be awake during 
elective cesarean sections. After surgery, a detailed pain regimen of intravenous and oral pain 
medications are used during your hospital stay. 
Before your surgery, you will be randomized (like picking a number out of a hat) to receive one of three 
nerve blocks. You will receive either a transversus abdominis plane block (two injections in the 
abdomen), an anterior quadratus lumborum block (two injections in the back), or an erector spinae block 
(two injections in the back) with ropivacaine (numbing medication). The nerve block will be performed 
AFTER your baby has been delivered at the end of your surgery. This block will interrupt skin to skin 
time for the duration of the procedure (5-10 minutes) to ensure safety for both mom and baby during 
positioning of the nerve blocks. After the block is complete, there will no limitations concerning 
DUHS IRB
IRB NUMBER: Pro00100742
IRB REFERENCE DATE: 01/13/2020
IRB EXPIRATION DATE: 01/23/2021


Consent to Participate in a Research Study
Comparison of TAP, Anterior QL, or ESP 
Block for Elective Cesarean Section 
Page 3 of 7                                                  Subject*Initials:______________
DUKE UNIVERSITY HEALTH SYSTEM
Form
M0345
positioning, mother/baby bonding, or breastfeeding. 
After surgery, we will monitor the amount of strong narcotic pain medication, such as oxycodone, 
medication that you need to manage your pain. We will also record your pain scores at various points 
immediately following surgery until 48 hours later. Additionally, we will contact one time via email or 
telephone after hospital discharge to complete a survey regarding your experience and satisfaction. The 
nerve block is in addition to the normal pain regimen and care you would normally receive had you not 
been in the study. 
If your treating anesthesiologist determines it is best for you to receive additional medication through a 
combined spinal epidural anesthetic during your cesarean section, you will be withdrawn from the study 
post-consent and will not receive any of the above mentioned blocks.  Instead, you will receive standard 
of care post-operative care.
HOW LONG WILL I BE IN THIS STUDY?
You will be in this study for 48 hours, however we may contact you via telephone one time after 
hospital discharge to complete a survey. You can choose to stop participating at any time without 
penalty or loss of any benefits to which you are entitled. However, if you decide to stop participating in 
the study, we encourage you to talk to your doctor first.
WHAT ARE THE RISKS OF THE STUDY?
You should discuss the risks of the study with the study doctor. As a result of your participating in this 
study, you are at risk for the following:
Risks Associated with Nerve Block:
Risks associated with the nerve block include minor pain or discomfort; bruising; infection at the needle 
insertion site; injury to arteries, veins, or nerves affecting the abdomen, back, or legs; residual 
numbness, weakness, or paralysis; headache; muscle soreness. If you are allergic to the local anesthetic 
(ropivacaine) or have an adverse drug reaction, you could possibly have a reaction that is severe enough 
to cause cardiac arrest (the heart stops beating) and/or respiratory arrest (you stop breathing). If there is 
injection of local anesthetic into a blood vessel, you could possibly have loss of consciousness, seizure, 
or cardiac arrest.
There have been rare case reports of hip or knee weakness after quadratus lumborum block. Therefore, 
we recommend having someone with you to help you out of bed the first time after the nerve block is 
performed.
Drug and Food Interactions:
For your safety, you must tell the study doctor or nurse about all prescribed medical foods and drugs, 
herbal products, over-the-counter (OTC) drugs, vitamins, natural remedies, and alcohol that you are 
taking before you start the study.
DUHS IRB
IRB NUMBER: Pro00100742
IRB REFERENCE DATE: 01/13/2020
IRB EXPIRATION DATE: 01/23/2021


Consent to Participate in a Research Study
Comparison of TAP, Anterior QL, or ESP 
Block for Elective Cesarean Section 
Page 4 of 7                                                  Subject*Initials:______________
DUKE UNIVERSITY HEALTH SYSTEM
Form
M0345
There may be additional risks, discomforts, drug interactions, or side effects that are not yet known.
There is a potential risk of loss of confidentiality.  Every effort will be made to keep your information 
confidential; however, this cannot be guaranteed. You may stop your participation in this study at any 
time.
ARE THERE BENEFITS TO TAKING PART IN THE STUDY?
If you agree to take part in this study, there may be direct medical benefit to you. You may experience 
improved pain control after surgery, but it is not yet known if this will be the case and this potential 
benefit cannot be guaranteed. It is not known how long this benefit may last after surgery. Improved 
pain control may result in the decreased need for strong narcotic pain medication, such as oxycodone, 
after surgery and thus decreased side effects like nausea, vomiting, constipation, or sedation. We hope 
that in the future the information learned from this study will benefit other people undergoing cesarean 
section.  
WHAT ALTERNATIVES ARE THERE TO PARTICIPATION IN THIS STUDY?
If you choose not to participate in the study you will receive the Duke University Hospital standard of 
care for elective cesarean section.  
WILL MY INFORMATION BE KEPT CONFIDENTIAL?
Participation in research involves some loss of privacy. We will do our best to make sure that 
information about you is kept confidential, but we cannot guarantee total confidentiality. Your personal 
information may be viewed by individuals involved in this research and may be seen by people 
including those collaborating, funding, and regulating the study. We will share only the minimum 
necessary information in order to conduct the research. Your personal information may also be given out 
if required by law. 
As part of the study, results of your study-related laboratory tests, x-rays, and procedures may be 
reported to Duke University Hospital Department of Anesthesiology and its affiliates. In addition, your 
records may be reviewed in order to meet federal or state regulations. Reviewers may include 
representatives from the Food and Drug Administration, representatives and affiliates of Duke 
University Hospital Department of Anesthesiology, the Duke University Health System Institutional 
Review Board, and others as appropriate. If any of these groups review your research record, they may 
also need to review your entire medical record.
As part of this study, you will be asked to have certain procedures performed. Some of these procedures 
would have been done as part of your regular care. The study doctor will use these results both to treat 
you and to complete this research.  These test results will be recorded in your medical record and will be 
reported to the Duke University Hospital Department of Anesthesiology. Results of tests and studies 
done solely for this research study and not as part of your regular care will also be included in your 
DUHS IRB
IRB NUMBER: Pro00100742
IRB REFERENCE DATE: 01/13/2020
IRB EXPIRATION DATE: 01/23/2021


Consent to Participate in a Research Study
Comparison of TAP, Anterior QL, or ESP 
Block for Elective Cesarean Section 
Page 5 of 7                                                  Subject*Initials:______________
DUKE UNIVERSITY HEALTH SYSTEM
Form
M0345
medical record.
While the information and data resulting from this study may be presented at scientific meetings or 
published in a scientific journal, your name or other personal information will not be revealed. 
Additionally, information and data resulting from this study may be used for future unspecified research, 
however your name and other personal information will not be revealed. 
Some people or groups who receive your health information might not have to follow the same privacy 
rules. Once your information is shared outside of DUHS, we cannot guarantee that it will remain private. 
If you decide to share private information with anyone not involved in the study, the federal law 
designed to protect your health information privacy may no longer apply to the information you have 
shared.  Other laws may or may not protect sharing of private health information.
WHAT ARE THE COSTS?
You or your insurance provider will be responsible and billed for all costs related to your routine 
medical care, including copayments and deductibles. Routine medical care services are those that you 
would have received for your condition if you were not participating in this research study. Not all 
services are covered by insurance.  Some procedures or scans may require pre-authorization by your 
insurance plan. We will notify you if we learn that a service is not covered by your insurance plan as 
part of the pre-authorization process. If it is not covered, you will be responsible for paying for it.  The 
amount of your out-of-pocket expense will depend on your insurance plan.  For beneficiaries with 
Medicare Advantage Plans, traditional Medicare is billed for the routine cost of a research study.  You 
may have more or higher co-pays than with a Medicare Advantage plan.  Please discuss the costs of the 
study with Dr. Kumar.  At your request, a Financial Counselor in the clinic may provide you with an 
estimate of costs for routine services.
WHAT ABOUT COMPENSATION?
You will not be compensated for your participation in this study.
WHAT ABOUT RESEARCH RELATED INJURIES?
Immediate necessary medical care is available at Duke University Hospital in the event that you are 
injured as a result of your participation in this research study. However, there is no commitment by 
Duke University, Duke University Health System, Inc., or your Duke University Hospital physicians to 
provide monetary compensation or free medical care to you in the event of a study-related injury.
For questions about the study or research-related injury, contact Dr. Kumar at (216) 385-5529 during 
regular business hours, after hours, and on weekends and holidays.
WHAT ABOUT MY RIGHTS TO DECLINE PARTICIPATION OR WITHDRAW FROM THE
STUDY?
You may choose not to be in the study, or, if you agree to be in the study, you may withdraw from the 
DUHS IRB
IRB NUMBER: Pro00100742
IRB REFERENCE DATE: 01/13/2020
IRB EXPIRATION DATE: 01/23/2021


Consent to Participate in a Research Study
Comparison of TAP, Anterior QL, or ESP 
Block for Elective Cesarean Section 
Page 6 of 7                                                  Subject*Initials:______________
DUKE UNIVERSITY HEALTH SYSTEM
Form
M0345
study at any time. If you withdraw from the study, no new data about you will be collected for study 
purposes unless the data concern an adverse event (a bad effect) related to the study. If such an adverse 
event occurs, we may need to review your entire medical record.  
Your decision not to participate or to withdraw from the study will not involve any penalty or loss of 
benefits to which you are entitled, and will not affect your access to health care at Duke University 
Hospital. 
If you do decide to withdraw, we ask that you contact Dr. Amanda Kumar in writing or by telephone 
and let her know that you are withdrawing from the study. The mailing address is Department of 
Anesthesiology, DUMC Box 3094, 2301 Erwin Road, Durham, NC, 27710. The telephone number is 
(216) 385-5529. 
We will tell you about new information that may affect your health, welfare, or willingness to stay in 
this study.
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. 
Law. This Web site will not include information that can identify you. At most, the Web site will 
include a summary of the results. You can search this Web site at any time.
WHOM DO I CALL IF I HAVE QUESTIONS OR PROBLEMS?
For questions about the study or a research-related injury, or if you have problems, concerns, questions 
or suggestions about the research, contact Dr. Kumar at (216) 385-5529 during regular business hours, 
after hours, and on weekends and holidays.
For questions about your rights as a research participant, or to discuss problems, concerns or suggestions 
related to the research, or to obtain information or offer input about the research, contact the Duke 
University Health System Institutional Review Board (IRB) Office at (919) 668-5111.
THIS SECTION INTENTIONALLY LEFT BLANK
DUHS IRB
IRB NUMBER: Pro00100742
IRB REFERENCE DATE: 01/13/2020
IRB EXPIRATION DATE: 01/23/2021


Consent to Participate in a Research Study
Comparison of TAP, Anterior QL, or ESP 
Block for Elective Cesarean Section 
Page 7 of 7
                                                  *
DUKE UNIVERSITY HEALTH SYSTEM
Form
M0345
STATEMENT OF CONSENT
"The purpose of this study, procedures to be followed, risks and benefits have been explained to me. I
have been allowed to ask questions, and my questions have been answered to my satisfaction. I have
been told whom to contact if I have questions, to discuss problems, concerns, or suggestions related to
the research, or to obtain information or offer input about the research. I have read this consent form
and agree to be in this study, with the understanding that I may withdraw at any time. I have been told
that I will be given a signed and dated copy of this consent form."
__________________________________________
 ___________ 
___________
Signature of Subject 
 Date 
Time
__________________________________________
Subject’s Printed Name
__________________________________________ 
 ___________
___________
Signature of Person Obtaining Consent 
 Date 
Time
DUHS IRB
IRB NUMBER: Pro00100742
IRB REFERENCE DATE: 01/13/2020
IRB EXPIRATION DATE: 01/23/2021