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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
82
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
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
University of Wisconsin Hospitals and Clinics (UWHC)
Madison, Wisconsin, United States
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).
Time frame: 24 hours post-surgery
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.
Time frame: 24 hours post-surgery
Length of hospital stay, measured in whole hours from admission to PACU to time of discharge order placement
Time frame: estimated to be up to 3 days
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.
Time frame: estimated to be up to 3 days
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.
Time frame: estimated to be up to 3 days
Return of bowel function measured in whole hours from completion of surgery to passage of flatus
Time frame: estimated to be up to 3 days
Participant Satisfaction at Postoperative Visit measured by two pain questions from the QoR-15 Patient Reported Outcomes Survey Score
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Scores are from 0-10 where 0 is pain all of the time and 10 is pain none of the time.
Time frame: post-operative visit (up to 60 days)
Readmission rate measured by readmission in the 30 days following surgery
Time frame: up to 30 days
Cost of care measured by aggregate cost of hospitalization following discharge from surgical hospital stay
Time frame: estimated to be up to 3 days
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.
Time frame: up to 30 days post-operatively
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.
Time frame: estimated to be within 72 hours post-surgery