Intraoperative TAP Block After Repeat Cesarean

Sponsor
University of Massachusetts, Worcester (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05393908
Collaborator
(none)
40
2
24

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: TAP Block Group
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Intraoperative Surgeon Administered Transversus Abdominis Plan (TAP) Block With Liposomal Bupivacaine and Post-operative Pain Control After Repeat Cesarean Delivery
Anticipated Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Aug 31, 2024
Anticipated Study Completion Date :
Aug 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: TAP Block Group

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

Procedure: TAP Block Group
Participants will receive a surgeon administered TAP block.

No Intervention: Standard of Care Postoperative Pain Control

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.

Outcome Measures

Primary Outcome Measures

  1. Daily Narcotic Use in Morphine Equivalents [From time of surgery through postpartum day 4]

    Daily Narcotic Use in Morphine Equivalents

Secondary Outcome Measures

  1. Time to first administered narcotic (oral or parental) [From time of surgery through postpartum day 4]

    Time to first administered narcotic (oral or parental) post cesarean delivery

  2. Daily Average Pain Score [From time of surgery through postpartum day 4]

    Daily Average Pain Score based on ten point pain scale (minimum 0, maximum 10) with higher numbers indicating worse pain

  3. Daily Maximum Pain Score [From time of surgery through postpartum day 4]

    Daily Average Pain Score based on ten point pain scale (minimum 0, maximum 10) with higher numbers indicating worse pain

  4. Time to First Ambulation [From time of surgery through postpartum day 4]

    Time to First Ambulation post cesarean delivery

  5. Time to First Solid Food [From time of surgery through postpartum day 4]

    Time to First Solid Food

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Massachusetts, Worcester

Investigators

  • Principal Investigator: Gianna Wilkie, MD, University of Massachusetts Chan Medical School

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Gianna Wilkie, Principal Investigator, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier:
NCT05393908
Other Study ID Numbers:
  • STUDY00000407
First Posted:
May 26, 2022
Last Update Posted:
May 26, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Gianna Wilkie, Principal Investigator, University of Massachusetts, Worcester
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 26, 2022