Intra-operative Uterosacral Ligament Bupivacaine Injection During Minimally Invasive Hysterectomy

• Status: Recruiting
• Trial end date: 2022-11-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Johns Hopkins University
• Treatments: Bupivacaine

Criteria

Inclusion Criteria:

• Women over the age of 18 years old

• undergoing benign minimally invasive hysterectomy with minimally invasive GYN surgeon at Johns Hopkins Hospital

• Patients must be English speaking.

Exclusion Criteria:

• Pregnancy

• allergy, contraindication, or intolerance to bupivacaine, opioids, Tylenol, or NSAID drugs

• pre-operative daily opioid consumption

• peri-operative transverse abdominis plane block

• recent history of drug or alcohol abuse (in last year)

• severe cardiovascular, hepatic or renal disease.