Protocol No.UW23039
Principal InvestigatorWallace, Sumer
PhaseIV (Cancer Control) (Cancer Prevention)
Age GroupAdult
ClinicalTrials.GovNCT06213454 (Click to jump to clinicaltrials.gov)
Management Group(s) Gynecologic

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

Description
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.

Objective
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.
Secondary Objectives

To evaluate the effects of the effects of preoperative TAP analgesia compared to surgeon-initiated wound infiltration with local anesthetic on subject-rated perception of pain in subjects undergoing laparotomy.
To evaluate the effects of preoperative TAP analgesia compared to surgeon-initiated wound infiltration with local anesthetic on length of hospital stay in subjects undergoing laparotomy.
To evaluate the effects of preoperative TAP analgesia compared to surgeon-initiated wound infiltration with local anesthetic on postoperative emetic use and number of recorded episodes of emesis in subjects undergoing laparotomy.
To evaluate the effects of preoperative TAP analgesia compared to surgeon-initiated wound infiltration with local anesthetic on return of bowel function in subjects undergoing laparotomy.
To evaluate the effects of preoperative TAP analgesia compared to surgeon-initiated wound infiltration with local anesthetic on subject satisfaction in subjects undergoing laparotomy.
To evaluate the effects of preoperative TAP analgesia compared to surgeon-initiated wound infiltration with local anesthetic on postoperative complications in subjects undergoing laparotomy.
To evaluate the effects of preoperative TAP analgesia compared to surgeon-initiated wound infiltration with local anesthetic on readmission rates in subjects undergoing laparotomy.
To evaluate the cost of care associated with TAP analgesia compared to surgeon-initiated wound infiltration with local anesthetic on readmission rates in subjects undergoing laparotomy.

Treatment Active Comparator: TAP Block plus Laparotomy
Drug: TAP 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
Other Names:
bupivacaine
liposomal bupivacaine

Active Comparator: Laparotomy plus Local Wound Anesthetic
Drug: Surgeon-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

Key Eligibility Inclusion Criteria:



    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 Criteria:


    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.

Applicable Disease Sites
Cervix; Ovary; Uterus

Participating Institutions
UW Health University Hospital