University of Wisconsin Hospitals and Clinics (UWHC)
Madison, Wisconsin, 53726, United States
Location status: Recruiting
NCT Number: NCT06213454
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.
Interested in participating?
Request Info18 year and older
Female
Interventional
Phase 4
Madison, Wisconsin, 53726, United States
Location status: Recruiting
Primary Objective
Secondary Objectives
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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
Time frame: 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).
Time frame: 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.
Time frame: estimated to be up to 3 days
Time frame: estimated to be up to 3 days
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.
Time frame: estimated to be up to 3 days
A study team member will review the patient's medical chart to record number of times the hospital staff observed a participant vomit.
Time frame: estimated to be up to 3 days
Time frame: post-operative visit (up to 60 days)
Scores are from 0-10 where 0 is pain all of the time and 10 is pain none of the time.
Time frame: up to 30 days
Time frame: estimated to be up to 3 days
Time frame: up to 30 days post-operatively
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.
Time frame: estimated to be within 72 hours post-surgery
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.
Contact information is provided by the study sponsor or research team.
University of Wisconsin, Madison
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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