About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
TAP Anesthesia
Drugultrasound 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
Drug266 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
Treatment groups
Trial outcomes
Primary outcomes
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).
Secondary outcomes
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.
Length of hospital stay, measured in whole hours from admission to PACU to time of discharge order placement
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.
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.
Sponsors and contacts
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