Intraoperative TAP Block After Repeat Cesarean

NCT05393908 | Withdrawn DMC

• 1 other identifier: STUDY00000407
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this study is to perform a randomized trial to investigate if intraoperative surgeon administered TAP block reduces pain and use of oral and parenteral pain medications after repeat cesarean delivery. The investigators aim to compare surgeon administered TAP block with liposomal bupivacaine compared to standard treatment (i.e. no TAP block) with regard to the primary outcome of post-operative narcotic use.

Conditions

Post-operative Pain

Keywords

Cesarean delivery, post-operative pain, TAP block

Outcome Measures

Primary Outcomes (1)

• Daily Narcotic Use in Morphine Equivalents

  Daily Narcotic Use in Morphine Equivalents

  From time of surgery through postpartum day 4

Secondary Outcomes (5)

• Time to first administered narcotic (oral or parental)

  From time of surgery through postpartum day 4

• Daily Average Pain Score

  From time of surgery through postpartum day 4

• Daily Maximum Pain Score

  From time of surgery through postpartum day 4

• Time to First Ambulation

  From time of surgery through postpartum day 4

• Time to First Solid Food

  From time of surgery through postpartum day 4

Study Arms (2)

TAP Block Group

ACTIVE COMPARATOR

Participants will receive a surgeon administered TAP block consisting of liposomal bupivacaine during their repeat cesarean delivery.

Procedure: TAP Block Group

Standard of Care Postoperative Pain Control

NO INTERVENTION

Participants will not receive a surgeon administered TAP block consisting of liposomal bupivacaine during their repeat cesarean delivery and will receive the routine standard of care for post-operative pain control.

Interventions

TAP Block Group PROCEDURE

Participants will receive a surgeon administered TAP block.

TAP Block Group

Eligibility Criteria

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

You may qualify if:

• Pregnant women presenting for elective repeat cesarean delivery at 37-42 weeks gestational age.
• Pregnancy and delivery care obtained at UMass Memorial Medical Center
• Patients able to provide written informed consent
• English, Spanish, or Portuguese-speaking patients

You may not qualify if:

• Participants who are under the age of 18 years
• Active labor.
• Baseline pain score \> 6.
• Unable to provide informed consent.
• Prisoners will be excluded from this research.
• Narcotic use in the 2 weeks prior to delivery.
• Active substance abuse.
• Inability to take narcotic analgesia.

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead

Related Publications (6)

• Wilson RD, Caughey AB, Wood SL, Macones GA, Wrench IJ, Huang J, Norman M, Pettersson K, Fawcett WJ, Shalabi MM, Metcalfe A, Gramlich L, Nelson G. Guidelines for Antenatal and Preoperative care in Cesarean Delivery: Enhanced Recovery After Surgery Society Recommendations (Part 1). Am J Obstet Gynecol. 2018 Dec;219(6):523.e1-523.e15. doi: 10.1016/j.ajog.2018.09.015. Epub 2018 Sep 18.

  PMID: 30240657 BACKGROUND

• Tsai HC, Yoshida T, Chuang TY, Yang SF, Chang CC, Yao HY, Tai YT, Lin JA, Chen KY. Transversus Abdominis Plane Block: An Updated Review of Anatomy and Techniques. Biomed Res Int. 2017;2017:8284363. doi: 10.1155/2017/8284363. Epub 2017 Oct 31.

  PMID: 29226150 BACKGROUND

• Kupiec A, Zwierzchowski J, Kowal-Janicka J, Gozdzik W, Fuchs T, Pomorski M, Zimmer M, Kubler A. The analgesic efficiency of transversus abdominis plane (TAP) block after caesarean delivery. Ginekol Pol. 2018;89(8):421-424. doi: 10.5603/GP.a2018.0072.

  PMID: 30215460 BACKGROUND

• Abdallah FW, Halpern SH, Margarido CB. Transversus abdominis plane block for postoperative analgesia after Caesarean delivery performed under spinal anaesthesia? A systematic review and meta-analysis. Br J Anaesth. 2012 Nov;109(5):679-87. doi: 10.1093/bja/aes279. Epub 2012 Aug 19.

  PMID: 22907337 BACKGROUND

• Kwikiriza A, Kiwanuka JK, Firth PG, Hoeft MA, Modest VE, Ttendo SS. The analgesic effects of intrathecal morphine in comparison with ultrasound-guided transversus abdominis plane block after caesarean section: a randomised controlled trial at a Ugandan regional referral hospital. Anaesthesia. 2019 Feb;74(2):167-173. doi: 10.1111/anae.14467. Epub 2018 Nov 1.

  PMID: 30383289 BACKGROUND

• Mishriky BM, George RB, Habib AS. Transversus abdominis plane block for analgesia after Cesarean delivery: a systematic review and meta-analysis. Can J Anaesth. 2012 Aug;59(8):766-78. doi: 10.1007/s12630-012-9729-1. Epub 2012 May 24.

  PMID: 22622954 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

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

Study Officials

• Gianna Wilkie, MD

  University of Massachusetts Chan Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 18, 2022
• First Posted: May 26, 2022
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: November 14, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share