To hear about similar clinical trials, please enter your email below
Trial Title:
Transversus Abdominis Plane Block Compared to Local Anesthetic Wound Infiltration in Gynecologic Oncology Surgery
NCT ID:
NCT06213454
Condition:
Analgesia
Surgery
Conditions: Official terms:
Bupivacaine
Anesthetics, Local
Anesthetics
Conditions: Keywords:
laparotomy
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
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
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
TAP Anesthesia
Description:
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
Arm group label:
TAP Block plus Laparotomy
Other name:
bupivacaine
Other name:
liposomal bupivacaine
Intervention type:
Drug
Intervention name:
Surgeon-Initiated Local Anesthetic
Description:
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
Arm group label:
Laparotomy plus Local Wound Anesthetic
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.
Criteria for 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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Wisconsin Hospitals and Clinics (UWHC)
Address:
City:
Madison
Zip:
53726
Country:
United States
Status:
Recruiting
Start date:
March 26, 2024
Completion date:
June 2025
Lead sponsor:
Agency:
University of Wisconsin, Madison
Agency class:
Other
Source:
University of Wisconsin, Madison
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06213454
