RecruitingPhase 4NCT06213454

Transversus Abdominis Plane Block Compared to Local Anesthetic Wound Infiltration in Gynecologic Oncology Surgery


Sponsor

University of Wisconsin, Madison

Enrollment

80 participants

Start Date

Mar 26, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This study is being done to see if preoperative transversus abdominis plane (TAP) analgesia will provide similar postoperative pain control, hospital length of stay, and postoperative outcomes compared to surgeon-initiated wound infiltration with local anesthetic in participants undergoing laparotomy for gynecologic indications.


Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria6

  • Ability to understand and the willingness to sign a written informed consent document
  • Patients undergoing exploratory laparotomy via midline vertical skin incision for gynecologic indications at UW Hospital and Clinics
  • Patients must be >18 years old
  • English speaking (able to provide consent and complete questionnaires)
  • Patients must have the ability to understand visual and verbal pain scales
  • Patients must be eligible for TAP block placement. This will be confirmed during preoperative visit with the primary surgeon. Patient's are not eligible if they have allergies to the anesthetic medications or have had prior abdominal reconstructive surgery that would alter their abdominal wall anatomy in a way where the block would not be expected to be effective.

Exclusion Criteria8

  • Known allergy to local anesthetics.
  • Known history of chronic pain disorders and/or chronic opioid use defined as greater than 10mg of PO morphine or equivalent used daily for at least 30 days prior to enrollment.
  • Patient has a history of opioid dependence requiring rehabilitation or the use of opioid antagonists.
  • Patients with a planned exploration with biopsies (no organs removed) will be excluded from the study.
  • Individuals who are pregnant, lactating or planning on becoming pregnant during the study.
  • Significant liver disease that would inhibit prescription of opioids.
  • Significant kidney disease that would inhibit administration of gabapentin.
  • Not suitable for study participation due to other reasons at the discretion of the investigators.

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Interventions

DRUGTAP Anesthesia

ultrasound guided TAP block, 133 mg of liposomal bupivacaine and 15 mL of 0.25% bupivacaine deposited into the TAP on each side for a total of two injections

DRUGSurgeon-Initiated Local Anesthetic

266 mg of liposomal bupivacaine and 30 mL of 0.25% bupivacaine diluted in 130 mL of normal saline (160 mL of solution), 40 mL fascial injection and 40 mL skin injection on either side of the wound


Locations(1)

University of Wisconsin Hospitals and Clinics (UWHC)

Madison, Wisconsin, United States

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NCT06213454


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