drugset / Trial / NCT04157075

Intra-operative Uterosacral Ligament Bupivacaine Injection During Minimally Invasive Hysterectomy

NCT04157075

Phase 0 Completed 180 enrolled Johns Hopkins University
RandomizedParallel-groupSingle-blindPrevention

Summary

This is proof of concept, phase I randomized controlled trial studying a short acting non-opioid anesthetic, bupivacaine to improve post-operative pain in gynecologic surgery patients. Patients who are undergoing minimally invasive (laparoscopic or robotic) hysterectomy will be randomized to receive no uterosacral injection, normal saline uterosacral injection, or 0.25% bupivacaine uterosacral injection just prior to colpotomy (incision around the cervix and removal of uterus) during minimally invasive hysterectomy.

Timeline

Start
2021-03-15
Primary completion
2022-10-15
Completion
2022-10-15

Drugs

EvaluationDrugModalityDoseRoute
Comparator Bupivacaine Other / unclassified 0.25 % Other
Comparator Bupivacaine Other / unclassified 20 ml Other