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Intraoperative TAP Block After Repeat Cesarean

U

University of Massachusetts, Worcester

Status

Withdrawn

Conditions

Post-operative Pain

Treatments

Procedure: TAP Block Group

Study type

Interventional

Funder types

Other

Identifiers

NCT05393908
STUDY00000407

Details and patient eligibility

About

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.

Full 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.

Sex

Female

Ages

18+ years old

Volunteers

Accepts 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

0 participants in 2 patient groups

TAP Block Group
Active Comparator group
Description:
Participants will receive a surgeon administered TAP block consisting of liposomal bupivacaine during their repeat cesarean delivery.
Treatment:
Procedure: TAP Block Group
Standard of Care Postoperative Pain Control
No Intervention group
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.

Trial contacts and locations

0

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Central trial contact

Gianna Wilkie, MD

Data sourced from clinicaltrials.gov

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