Clinical trial NCT06213454: Transversus Abdominis Plane Block Compared to Local Anesthetic Wound Infiltration in Gynecologic Oncology Surgery
Official title: Transversus Abdominis Plane Block Compared to Local Anesthetic Wound Infiltration in Gynecologic Oncology Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Analgesia
Surgery
Keywords: laparotomy
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2024-01-19
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a randomized, unblinded, single-center trial testing the hypothesis that surgeon-initiated wound infiltration with local anesthetic is non-inferior in providing postoperative pain control when compared with preoperative TAP analgesia.
Primary purpose: SUPPORTIVE_CARE

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 compared to surgeon-initiated wound infiltration with local anesthetic in participants undergoing laparotomy for gynecologic indications.

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.

Secondary Objectives

* To evaluate 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 anti-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.

Eligibility criteria: 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.

Primary outcomes:
measure: Total opioid use measured in oral morphine equivalents for the first 24 hours post-surgery
timeFrame: 24 hours post-surgery
Secondary outcomes:
measure: Mean postoperative pain score for the first 24 hours post-surgery
timeFrame: 24 hours post-surgery
measure: Length of hospital stay, measured in whole hours from admission to PACU to time of discharge order placement
timeFrame: estimated to be up to 3 days
measure: Post-operative anti-emetic use
timeFrame: estimated to be up to 3 days
measure: Number of recorded episodes of emesis
timeFrame: estimated to be up to 3 days
measure: Return of bowel function measured in whole hours from completion of surgery to passage of flatus
timeFrame: estimated to be up to 3 days
measure: Participant Satisfaction at Postoperative Visit measured by two pain questions from the QoR-15 Patient Reported Outcomes Survey Score
timeFrame: post-operative visit (up to 60 days)
measure: Readmission rate measured by readmission in the 30 days following surgery
timeFrame: up to 30 days
measure: Cost of care measured by aggregate cost of hospitalization following discharge from surgical hospital stay
timeFrame: estimated to be up to 3 days
measure: Summary of Post-operative Complications
timeFrame: up to 30 days post-operatively
measure: Time to First Ambulation measured in hours
timeFrame: estimated to be within 72 hours post-surgery
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin Hospitals and Clinics (UWHC)
state: Wisconsin
Study officials:
affiliation: UW Carbone Cancer Center
name: Sumer Wallace, MD
role: PRINCIPAL_INVESTIGATOR
References: