Intra-operative Uterosacral Ligament Bupivacaine Injection During Minimally Invasive Hysterectomy

Completed · Early Phase 1

Conditions studied: Pain, Postoperative, Opioid Use

In brief

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.

Key facts

Study ID

NCT04157075

Run by

Johns Hopkins University

People needed

180

Starts

2021-03-15

Expected to finish

2022-10-15

Last updated by the study team

2022-11-09

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Johns Hopkins Hospital — Baltimore, Maryland, United States
• Howard County General Hospital — Columbia, Maryland, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.