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Comparison of TAP, Anterior QL, or ESP Block for Elective Cesarean Section

Primary Purpose

Pain, Postoperative, Cesarean Section

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ropivacaine
TAP block
QL block
ESP block
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  1. American Society of Anesthesiologists (ASA) Physical Status 1-3
  2. Age greater than or equal to 18 years
  3. Scheduled for elective 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

Sites / Locations

  • Duke University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

TAP block

QL block

ESP block

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Postoperative Opioid Consumption
Amount of opioid in milligrams.
Postoperative Opioid Consumption
Amount of opioid
Postoperative Opioid Consumption
Amount of opioid
Postoperative Opioid Consumption
Amount of opioid
Postoperative Pain Scores
Visual Analog Scale at rest with 0 being no pain and 10 being the worst pain imaginable
Postoperative Pain Scores
Visual Analog Scale at rest with 0 being no pain and 10 being the worst pain imaginable
Postoperative Pain Scores
Visual Analog Scale at rest with 0 being no pain and 10 being the worst pain imaginable
Postoperative Pain Scores
Visual Analog Scale at rest with 0 being no pain and 10 being the worst pain imaginable

Secondary Outcome Measures

Number of Participants Requiring Antipruritics
Number of Participants Requiring Antipruritics
Number of Participants Requiring Antipruritics
Number of Participants Requiring Antipruritics
Number of Participants Requiring Antiemetics
Number of Participants Requiring Antiemetics
Number of Participants Requiring Antiemetics
Number of Participants Requiring Antiemetics
Overall Satisfaction With Pain Control
Satisfaction Rating, with 0 being not at all satisfied and 10 being completely satisfied

Full Information

First Posted
October 2, 2018
Last Updated
January 3, 2022
Sponsor
Duke University
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1. Study Identification

Unique Protocol Identification Number
NCT03695172
Brief Title
Comparison of TAP, Anterior QL, or ESP Block for Elective Cesarean Section
Official Title
Comparison of TAP, Anterior QL, or ESP Block for Elective Cesarean Section
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Terminated
Why Stopped
Decline of eligible participants
Study Start Date
September 12, 2019 (Actual)
Primary Completion Date
March 18, 2021 (Actual)
Study Completion Date
March 20, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Cesarean Section

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Patients will be randomly assigned to one of three treatment groups, TAP, QL, or ESP blocks
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TAP block
Arm Type
Active Comparator
Arm Description
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 Title
QL block
Arm Type
Active Comparator
Arm Description
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 Title
ESP block
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Intervention Description
Patients will be randomly assigned to receive one three blocks (TAP, QL, ESP)after delivery of baby with ropivicaine
Intervention Type
Procedure
Intervention Name(s)
TAP block
Intervention Description
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 Type
Biological
Intervention Name(s)
QL block
Intervention Description
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 Type
Procedure
Intervention Name(s)
ESP block
Intervention Description
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.
Primary Outcome Measure Information:
Title
Postoperative Opioid Consumption
Description
Amount of opioid in milligrams.
Time Frame
2 hours postoperatively
Title
Postoperative Opioid Consumption
Description
Amount of opioid
Time Frame
6 hours postoperatively
Title
Postoperative Opioid Consumption
Description
Amount of opioid
Time Frame
24 hours postoperatively
Title
Postoperative Opioid Consumption
Description
Amount of opioid
Time Frame
48 hours postoperatively
Title
Postoperative Pain Scores
Description
Visual Analog Scale at rest with 0 being no pain and 10 being the worst pain imaginable
Time Frame
2 hours postoperatively
Title
Postoperative Pain Scores
Description
Visual Analog Scale at rest with 0 being no pain and 10 being the worst pain imaginable
Time Frame
6 hours postoperatively
Title
Postoperative Pain Scores
Description
Visual Analog Scale at rest with 0 being no pain and 10 being the worst pain imaginable
Time Frame
24 hours postoperatively
Title
Postoperative Pain Scores
Description
Visual Analog Scale at rest with 0 being no pain and 10 being the worst pain imaginable
Time Frame
48 hours postoperatively
Secondary Outcome Measure Information:
Title
Number of Participants Requiring Antipruritics
Time Frame
2 hours postoperatively
Title
Number of Participants Requiring Antipruritics
Time Frame
6 hours postoperatively
Title
Number of Participants Requiring Antipruritics
Time Frame
24 hours postoperatively
Title
Number of Participants Requiring Antipruritics
Time Frame
48 hours postoperatively
Title
Number of Participants Requiring Antiemetics
Time Frame
2 hours postoperatively
Title
Number of Participants Requiring Antiemetics
Time Frame
6 hours postoperatively
Title
Number of Participants Requiring Antiemetics
Time Frame
24 hours postoperatively
Title
Number of Participants Requiring Antiemetics
Time Frame
48 hours postoperatively
Title
Overall Satisfaction With Pain Control
Description
Satisfaction Rating, with 0 being not at all satisfied and 10 being completely satisfied
Time Frame
1 week postoperatively

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: American Society of Anesthesiologists (ASA) Physical Status 1-3 Age greater than or equal to 18 years Scheduled for elective cesarean section English speaking Exclusion Criteria: ASA Physical Status 4-5 Diagnosis of chronic pain Chronic opioid use (opioid use in the past 3 months) Preoperative use of SSRIs (Celexa, Lexapro, Prozac, Paxil), SNRIs (Cymbalta, Effexor), gabapentin, or pregabalin (Lyrica) Inability to cooperate with or understand protocol Inability to communicate pain scores or need for analgesia Infection at the site of block placement Intolerance or allergy to local anesthetics Neurologic deficit or disorder Blood thinning disorder or taking anticoagulant medication BMI > 50 kg/m2 Suspected or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the investigator, may interfere with study assessments or compliance 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amanda Kumar, MD
Organizational Affiliation
Duke
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
17019104
Citation
Marcus MA, Brodner G. Are opioids contraindicated as postoperative pain relief for patients who are breast-feeding their newborn? Curr Opin Anaesthesiol. 2001 Jun;14(3):287-9. doi: 10.1097/00001503-200106000-00001. No abstract available.
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Marcus H, Gerbershagen HJ, Peelen LM, Aduckathil S, Kappen TH, Kalkman CJ, Meissner W, Stamer UM. Quality of pain treatment after caesarean section: Results of a multicentre cohort study. Eur J Pain. 2015 Aug;19(7):929-39. doi: 10.1002/ejp.619. Epub 2014 Nov 21.
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Comparison of TAP, Anterior QL, or ESP Block for Elective Cesarean Section

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