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

NCT03695172 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: Pro00100742
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative; Cesarean Section

Outcome Measures

Primary Outcomes (8)

• Postoperative Opioid Consumption

  Amount of opioid in milligrams.

  2 hours postoperatively

• Postoperative Opioid Consumption

  Amount of opioid

  6 hours postoperatively

• Postoperative Opioid Consumption

  Amount of opioid

  24 hours postoperatively

• Postoperative Opioid Consumption

  Amount of opioid

  48 hours postoperatively

• Postoperative Pain Scores

  Visual Analog Scale at rest with 0 being no pain and 10 being the worst pain imaginable

  2 hours postoperatively

• Postoperative Pain Scores

  Visual Analog Scale at rest with 0 being no pain and 10 being the worst pain imaginable

  6 hours postoperatively

• Postoperative Pain Scores

  Visual Analog Scale at rest with 0 being no pain and 10 being the worst pain imaginable

  24 hours postoperatively

• Postoperative Pain Scores

  Visual Analog Scale at rest with 0 being no pain and 10 being the worst pain imaginable

  48 hours postoperatively

Secondary Outcomes (9)

• Number of Participants Requiring Antipruritics

  2 hours postoperatively

• Number of Participants Requiring Antipruritics

  6 hours postoperatively

• Number of Participants Requiring Antipruritics

  24 hours postoperatively

• Number of Participants Requiring Antipruritics

  48 hours postoperatively

• Number of Participants Requiring Antiemetics

  2 hours postoperatively

Study Arms (3)

TAP block

ACTIVE COMPARATOR

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.

Drug: Ropivacaine; Procedure: TAP block

QL block

ACTIVE COMPARATOR

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.

Drug: Ropivacaine; Biological: QL block

ESP block

ACTIVE COMPARATOR

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.

Drug: Ropivacaine; Procedure: ESP block

Interventions

Ropivacaine DRUG

Patients will be randomly assigned to receive one three blocks (TAP, QL, ESP)after delivery of baby with ropivicaine

ESP block; QL block; TAP block

TAP block PROCEDURE

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.

TAP block

QL block BIOLOGICAL

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.

QL block

ESP block PROCEDURE

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.

ESP block

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologists (ASA) Physical Status 1-3
• Age greater than or equal to 18 years
• Scheduled for elective cesarean section
• English speaking

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related Publications (16)

• 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.

  PMID: 17019104 BACKGROUND

• 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.

  PMID: 25413847 BACKGROUND

• Bateman BT, Cole NM, Maeda A, Burns SM, Houle TT, Huybrechts KF, Clancy CR, Hopp SB, Ecker JL, Ende H, Grewe K, Raposo Corradini B, Schoenfeld RE, Sankar K, Day LJ, Harris L, Booth JL, Flood P, Bauer ME, Tsen LC, Landau R, Leffert LR. Patterns of Opioid Prescription and Use After Cesarean Delivery. Obstet Gynecol. 2017 Jul;130(1):29-35. doi: 10.1097/AOG.0000000000002093.

  PMID: 28594763 BACKGROUND

• Osmundson SS, Schornack LA, Grasch JL, Zuckerwise LC, Young JL, Richardson MG. Postdischarge Opioid Use After Cesarean Delivery. Obstet Gynecol. 2017 Jul;130(1):36-41. doi: 10.1097/AOG.0000000000002095.

  PMID: 28594766 BACKGROUND

• Bateman BT, Franklin JM, Bykov K, Avorn J, Shrank WH, Brennan TA, Landon JE, Rathmell JP, Huybrechts KF, Fischer MA, Choudhry NK. Persistent opioid use following cesarean delivery: patterns and predictors among opioid-naive women. Am J Obstet Gynecol. 2016 Sep;215(3):353.e1-353.e18. doi: 10.1016/j.ajog.2016.03.016. Epub 2016 Mar 17.

  PMID: 26996986 BACKGROUND

• Eslamian L, Jalili Z, Jamal A, Marsoosi V, Movafegh A. Transversus abdominis plane block reduces postoperative pain intensity and analgesic consumption in elective cesarean delivery under general anesthesia. J Anesth. 2012 Jun;26(3):334-8. doi: 10.1007/s00540-012-1336-3. Epub 2012 Feb 22.

  PMID: 22354671 BACKGROUND

• Fusco P, Scimia P, Paladini G, Fiorenzi M, Petrucci E, Pozone T, Vacca F, Behr A, Micaglio M, Danelli G, Cofini V, Necozione S, Carta G, Petrini F, Marinangeli F. Transversus abdominis plane block for analgesia after Cesarean delivery. A systematic review. Minerva Anestesiol. 2015 Feb;81(2):195-204. Epub 2014 Apr 16.

  PMID: 24739207 BACKGROUND

• Factor D, Chin KJ. Transversus abdominis plane block in lower segment cesarean section: a question of block failure or lack of efficacy? Reg Anesth Pain Med. 2010 Jul-Aug;35(4):404-5. doi: 10.1097/AAP.0b013e3181e66f01. No abstract available.

  PMID: 20588155 BACKGROUND

• Loane H, Preston R, Douglas MJ, Massey S, Papsdorf M, Tyler J. A randomized controlled trial comparing intrathecal morphine with transversus abdominis plane block for post-cesarean delivery analgesia. Int J Obstet Anesth. 2012 Apr;21(2):112-8. doi: 10.1016/j.ijoa.2012.02.005. Epub 2012 Mar 10.

  PMID: 22410586 BACKGROUND

• Blanco R, Ansari T, Riad W, Shetty N. Quadratus Lumborum Block Versus Transversus Abdominis Plane Block for Postoperative Pain After Cesarean Delivery: A Randomized Controlled Trial. Reg Anesth Pain Med. 2016 Nov/Dec;41(6):757-762. doi: 10.1097/AAP.0000000000000495.

  PMID: 27755488 BACKGROUND

• Kadam VR. 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 Jan-Mar;31(1):130-1. doi: 10.4103/0970-9185.150575. No abstract available.

  PMID: 25788791 BACKGROUND

• Kadam VR, Howell S. 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 Jul;62(7):555-557. doi: 10.4103/ija.IJA_242_18. No abstract available.

  PMID: 30078860 BACKGROUND

• Chin KJ, Malhas L, Perlas A. The Erector Spinae Plane Block Provides Visceral Abdominal Analgesia in Bariatric Surgery: A Report of 3 Cases. Reg Anesth Pain Med. 2017 May/Jun;42(3):372-376. doi: 10.1097/AAP.0000000000000581.

  PMID: 28272292 BACKGROUND

• Luis-Navarro JC, Seda-Guzman M, Luis-Moreno C, Chin KJ. Erector spinae plane block in abdominal surgery: Case series. Indian J Anaesth. 2018 Jul;62(7):549-554. doi: 10.4103/ija.IJA_57_18.

  PMID: 30078859 BACKGROUND

• Tulgar S, Selvi O, Kapakli MS. Erector Spinae Plane Block for Different Laparoscopic Abdominal Surgeries: Case Series. Case Rep Anesthesiol. 2018 Feb 18;2018:3947281. doi: 10.1155/2018/3947281. eCollection 2018.

  PMID: 29670771 BACKGROUND

• Yamak Altinpulluk E, Garcia Simon D, Fajardo-Perez M. Erector spinae plane block for analgesia after lower segment caesarean section: Case report. Rev Esp Anestesiol Reanim (Engl Ed). 2018 May;65(5):284-286. doi: 10.1016/j.redar.2017.11.006. Epub 2018 Jan 17. English, Spanish.

  PMID: 29352577 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Amanda Kumar, MD
• Organization: Duke University Medical Center

amanda.kumar@duke.edu

919-681-4607

Study Officials

• Amanda Kumar, MD

  Duke

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be randomly assigned to one of three treatment groups, TAP, QL, or ESP blocks

Study Record Dates

• First Submitted: October 2, 2018
• First Posted: October 3, 2018
• Study Start: September 12, 2019
• Primary Completion: March 18, 2021
• Study Completion: March 20, 2021
• Last Updated: January 12, 2022
• Results First Posted: January 12, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)