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Intraoperative TAP Block After Repeat Cesarean

Primary Purpose

Post-operative Pain

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
TAP Block Group
Sponsored by
University of Massachusetts, Worcester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-operative Pain focused on measuring Cesarean delivery, post-operative pain, TAP block

Eligibility Criteria

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

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    No Intervention

    Arm Label

    TAP Block Group

    Standard of Care Postoperative Pain Control

    Arm Description

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

    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.

    Outcomes

    Primary Outcome Measures

    Daily Narcotic Use in Morphine Equivalents
    Daily Narcotic Use in Morphine Equivalents

    Secondary Outcome Measures

    Time to first administered narcotic (oral or parental)
    Time to first administered narcotic (oral or parental) post cesarean delivery
    Daily Average Pain Score
    Daily Average Pain Score based on ten point pain scale (minimum 0, maximum 10) with higher numbers indicating worse pain
    Daily Maximum Pain Score
    Daily Average Pain Score based on ten point pain scale (minimum 0, maximum 10) with higher numbers indicating worse pain
    Time to First Ambulation
    Time to First Ambulation post cesarean delivery
    Time to First Solid Food
    Time to First Solid Food

    Full Information

    First Posted
    May 18, 2022
    Last Updated
    May 2, 2023
    Sponsor
    University of Massachusetts, Worcester
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05393908
    Brief Title
    Intraoperative TAP Block After Repeat Cesarean
    Official Title
    Intraoperative Surgeon Administered Transversus Abdominis Plan (TAP) Block With Liposomal Bupivacaine and Post-operative Pain Control After Repeat Cesarean Delivery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 1, 2024 (Anticipated)
    Primary Completion Date
    August 31, 2025 (Anticipated)
    Study Completion Date
    August 31, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Massachusetts, Worcester

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    Detailed Description
    Transversus abdominis plane (TAP) block is a well-described technique to provide a field block for analgesia. It has been shown to be effective in postoperative analgesia after cesarean delivery. TAP blocks are commonly performed post-operatively by anesthesiologists using liposomal bupivacaine with ultrasound guidance. Liposomal bupivacaine is an FDA approved medication for post-surgical analgesia and available at UMass-Memorial Medical Center. Liposomal bupivacaine provides sustained release of medication for up to 120 hours. A recent multicenter randomized controlled trial demonstrated the efficacy of anesthesiologist administered TAP blocks using liposomal bupivacaine after cesarean delivery. Infiltration of the skin and fascia with liposomal bupivacaine after cesarean did not have an effect and this can be explained by the path that the pain fibers take through the TAP which makes them amenable to a TAP block while a superficial infiltration is ineffective.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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Post-operative Pain
    Keywords
    Cesarean delivery, post-operative pain, TAP block

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    TAP Block Group
    Arm Type
    Active Comparator
    Arm Description
    Participants will receive a surgeon administered TAP block consisting of liposomal bupivacaine during their repeat cesarean delivery.
    Arm Title
    Standard of Care Postoperative Pain Control
    Arm Type
    No Intervention
    Arm Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    TAP Block Group
    Intervention Description
    Participants will receive a surgeon administered TAP block.
    Primary Outcome Measure Information:
    Title
    Daily Narcotic Use in Morphine Equivalents
    Description
    Daily Narcotic Use in Morphine Equivalents
    Time Frame
    From time of surgery through postpartum day 4
    Secondary Outcome Measure Information:
    Title
    Time to first administered narcotic (oral or parental)
    Description
    Time to first administered narcotic (oral or parental) post cesarean delivery
    Time Frame
    From time of surgery through postpartum day 4
    Title
    Daily Average Pain Score
    Description
    Daily Average Pain Score based on ten point pain scale (minimum 0, maximum 10) with higher numbers indicating worse pain
    Time Frame
    From time of surgery through postpartum day 4
    Title
    Daily Maximum Pain Score
    Description
    Daily Average Pain Score based on ten point pain scale (minimum 0, maximum 10) with higher numbers indicating worse pain
    Time Frame
    From time of surgery through postpartum day 4
    Title
    Time to First Ambulation
    Description
    Time to First Ambulation post cesarean delivery
    Time Frame
    From time of surgery through postpartum day 4
    Title
    Time to First Solid Food
    Description
    Time to First Solid Food
    Time Frame
    From time of surgery through postpartum day 4

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 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 Exclusion Criteria: 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Gianna Wilkie, MD
    Phone
    508-334-9189
    Email
    Gianna.Wilkie@umassmemorial.org
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Gianna Wilkie, MD
    Organizational Affiliation
    University of Massachusetts Chan Medical School
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    30240657
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    29226150
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    30215460
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    22907337
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    30383289
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    22622954
    Citation
    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.
    Results Reference
    background

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    Intraoperative TAP Block After Repeat Cesarean

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