NCT04157075

Intra-operative Uterosacral Ligament Bupivacaine Injection During Minimally Invasive Hysterectomy

The Effect of Intra-operative Uterosacral Bupivacaine Injection on Post-operative Pain in Patients Undergoing Minimally Invasive Hysterectomy

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 180 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Pain, Postoperative
• Opioid Use

Interventions

Type	Name	Description
DRUG	Bupivacaine	Bupivicaine injection into uterosacral ligaments prior to colpotomy

Timeline

• Start date: 2021-03-15
• Primary completion: 2022-10-15
• Completion: 2022-10-15
• First posted: 2019-11-08
• Last updated: 2022-11-09

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study