Status:
RECRUITING
Transversus Abdominis Plane Block Compared to Local Anesthetic Wound Infiltration in Gynecologic Oncology Surgery
Lead Sponsor:
University of Wisconsin, Madison
Conditions:
Analgesia
Surgery
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief 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 compare...
Detailed Description
Primary Objective * To evaluate the effects of preoperative TAP analgesia compared to surgeon-initiated wound infiltration with local anesthetic on pain control in subjects undergoing laparotomy. Se...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 26 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06213454
Start Date
March 26 2024
End Date
June 1 2026
Last Update
May 16 2025
Active Locations (1)
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1
University of Wisconsin Hospitals and Clinics (UWHC)
Madison, Wisconsin, United States, 53726