This clinical trial is being done to compare two different methods of postoperative pain control, transversus abdominis plane (TAP) block or surgeon-initiated wound infiltration, to control pain after gynecologic oncology surgery. There are two common ways to reduce the use of opioids (or pain-relieving drugs) needed after surgery. One way is to use a TAP block. A TAP block is an injection of an anesthetic medication into the area of the abdominal wall where there are nerves that feel pain. This medication numbs the nerves and stops the feeling of pain. This happens before surgery. The other common way to avoid using opioids to reduce pain is for the surgeon to inject anesthetic medication directly into the wound before closing it during the surgery. This medication would also help control pain. This is called surgeon-initiated wound infiltration with local anesthetic and happens during the surgery. This study may help researchers find out if both methods are equally as good at controlling pain after surgery.
Additional locations may be listed on ClinicalTrials.gov for NCT06213454.
Locations matching your search criteria
United States
Wisconsin
Madison
University of Wisconsin Carbone Cancer Center - University HospitalStatus: Active
Contact: Sumer K Wallace
Phone: 608-262-2262
University of Wisconsin Carbone Cancer Center - Eastpark Medical CenterStatus: Active
Contact: Sumer K Wallace
PRIMARY OBJECTIVE:
I. 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:
I. 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.
II. 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.
III. 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.
IV. 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.
V. To evaluate the effects of preoperative TAP analgesia compared to surgeon-initiated wound infiltration with local anesthetic on subject satisfaction in subjects undergoing laparotomy.
VI. To evaluate the effects of preoperative TAP analgesia compared to surgeon-initiated wound infiltration with local anesthetic on postoperative complications in subjects undergoing laparotomy.
VII. To evaluate the effects of preoperative TAP analgesia compared to surgeon-initiated wound infiltration with local anesthetic on readmission rates in subjects undergoing laparotomy.
VIII. 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.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive preoperative TAP block with bupivacaine hydrochloride and liposomal bupivacaine and then undergo exploratory laparotomy.
ARM II: Patients undergo exploratory laparotomy and receive surgeon-initiated wound infiltration with local anesthetic with bupivacaine hydrochloride and liposomal bupivacaine.
After completion of study intervention, patients are followed up at 60 days.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationUniversity of Wisconsin Carbone Cancer Center - University Hospital
Principal InvestigatorSumer K Wallace
