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| ID | Type | Description | Link |
|---|---|---|---|
| UW23039 | Other Identifier | UWCCC | |
| NCI-2023-10464 | Registry Identifier | NCI CTRP | |
| Protocol Version 7/17/2024 | Other Identifier | UW Madison | |
| A532820 | Other Identifier | UW Madison |
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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
Secondary Objectives
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAP Block plus Laparotomy | Active Comparator |
| |
| Laparotomy plus Local Wound Anesthetic | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAP Anesthesia | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 24 hours post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 hours post-surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cancer Connect | Contact | 800-622-8922 | clinicaltrials@cancer.wisc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Sumer Wallace, MD | UW Carbone Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin Hospitals and Clinics (UWHC) | Recruiting | Madison | Wisconsin | 53726 | United States |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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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.
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|
| Surgeon-Initiated Local Anesthetic | Drug | 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 |
|
| 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 | 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. | 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. | estimated to be up to 3 days |
| 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 | Scores are from 0-10 where 0 is pain all of the time and 10 is pain none of the time. | post-operative visit (up to 60 days) |
| Readmission rate measured by readmission in the 30 days following surgery | up to 30 days |
| Cost of care measured by aggregate cost of hospitalization following discharge from surgical hospital stay | 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. | 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. | estimated to be within 72 hours post-surgery |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000588 |
| Amines |