Analgesia, Surgery
Conditions
Keywords
laparotomy
Brief 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.
Interventions
DRUGTAP Anesthesia
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
Sponsors
University of Wisconsin, Madison
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total opioid use measured in oral morphine equivalents for the first 24 hours post-surgery | 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
| Measure | Time frame | Description |
|---|---|---|
| Time to First Ambulation measured in hours | 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. |
| Mean postoperative pain score for the first 24 hours post-surgery | 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 | estimated to be up to 3 days | — |
| Post-operative anti-emetic use | 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. |
| Number of recorded episodes of emesis | 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. |
| Return of bowel function measured in whole hours from completion of surgery to passage of flatus | 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 | 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. |
| Readmission rate measured by readmission in the 30 days following surgery | up to 30 days | — |
| Summary of Post-operative Complications | 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. |
| Cost of care measured by aggregate cost of hospitalization following discharge from surgical hospital stay | estimated to be up to 3 days | — |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSumer Wallace, MD
UW Carbone Cancer Center
Outcome results
None listed