drugset / Trial / NCT03870685

Surgical Site Infiltration of Exparel vs TAP Block With Exparel in Patients Undergoing Laparotomy Via Midline Incision

NCT03870685 ↗

Phase 4 Unknown 43 enrolled Danbury Hospital
RandomizedParallel-groupSingle-blindTreatment

Summary

This is a randomized-controlled prospective study to be conducted at Danbury Hospital and Norwalk Hospital to compare postoperative opioid consumption and pain scores of patients with suspected or known gynecologic malignancies undergoing midline laparotomy who received TAP block with liposomal bupivacaine versus surgical site infiltration of liposomal bupivacaine. Primary outcome: Total postoperative opioid consumption as measured by morphine equivalents over 48 hour period. Secondary outcomes include: Pain scores (based on visual analog scale 1-10) at 2 hours, 6 hours, 12 hours, 24 hours and 48 hours postoperatively at rest and upon exertion (Valsalva maneuver), Severity of nausea, Episodes of vomiting, Total antiemetics consumption over 48 hour period.

Timeline

Start
2018-07-05
Primary completion
2021-02-15
Completion
2021-12-31

Publications

Drugs

EvaluationDrugModalityDoseRoute
Comparator Bupivacaine Other / unclassified — Other