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

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06213454
• Other study ID #: 2023-1099
• Secondary ID: UW23039NCI-2023-
• Status: Recruiting
• Phase: Phase 4
• Start date: March 26, 2024
• Est. completion date: June 2025

Study information

• Verified date: April 2024
• Source: University of Wisconsin, Madison
• Contact: Cancer Connect
• Phone: 800-622-8922
• Email: clinicaltrials[@]cancer.wisc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

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.

Related Conditions & MeSH terms

• Analgesia
• Surgery

Intervention

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
• 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

Locations

Country	Name	City	State
United States	University of Wisconsin Hospitals and Clinics (UWHC)	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total opioid use measured in oral morphine equivalents for the first 24 hours post-surgery	Total opioid use measured in oral morphine equivalents for the first 24 hours post-surgery (including intraoperative and Post Anesthesia Care Unit (PACU) opioid utilization).	24 hours post-surgery
Secondary	Mean postoperative pain score for the first 24 hours post-surgery	Mean postoperative pain score for the first 24 hours post-surgery, measured by the Numeric Rating Scale (NRS), which rates pain on a 0-10 scale (collected routinely on the post-operative floor). Higher numbers indicate worse pain.	24 hours post-surgery
Secondary	Length of hospital stay, measured in hours from admission to time of discharge order placement		estimated to be up to 3 days
Secondary	Post-operative anti-emetic use	A study team member will review the patient's medical chart to record the number of times an anti-emetic was given to the subject.	estimated to be up to 3 days
Secondary	Number of recorded episodes of emesis	A study team member will review the patient's medical chart to record number of times the hospital staff observed a participant vomit.	estimated to be up to 3 days
Secondary	Return of bowel function measured in hours from completion of surgery to passage of flatus		estimated to be up to 3 days
Secondary	Participant Satisfaction at Postoperative Visit measured by two pain questions from the QoR-15 Patient Reported Outcomes Survey Score	Scores are from 0-10 where 0 is pain all of the time and 10 is pain none of the time.	post-operative visit (up to 60 days)
Secondary	Readmission rate measured by readmission in the 30 days following surgery		up to 30 days
Secondary	Cost of care measured by aggregate cost of hospitalization following discharge from surgical hospital stay		estimated to be up to 3 days
Secondary	Summary of Post-operative Complications	Postoperative complications, as defined by urinary tract infections, thromboembolic events, pneumonia, blood transfusion, cardiac events, falls, and electrolyte disturbances will be summarized by type and number of complications.	up to 30 days post-operatively
Secondary	Time to First Ambulation measured in hours	A study team member will review the participant's medical chart to record the interval (in hours) from completion of surgery to first ambulation after surgery.	estimated to be within 72 hours post-surgery