Intra-operative Uterosacral Ligament Bupivacaine Injection During Minimally Invasive Hysterectomy

Early Phase 1

Completed

• Conditions: Opioid Use; Pain, Postoperative
• Interventions: Drug: Bupivacaine

• Registration Number: NCT04157075
• Lead Sponsor: Johns Hopkins University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-11-06
• Study First Submitted QC: 2019-11-07
• Study First Posted: 2019-11-08
• Study Start: 2021-03-15
• Status Verified: 2022-03
• Primary Completion: 2022-10-15
• Study Completion: 2022-10-15
• Last Update Submitted: 2022-11-07
• Last Update Posted: 2022-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 180

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No injection	Bupivacaine	No injection will be performed
Normal Saline Injection	Bupivacaine	Normal saline will be injected into the uterosacral ligaments prior to colpotomy
Bupivacaine Injection	Bupivacaine	Bupivacaine will be injected into the uterosacral ligaments prior to colpotomy

Primary Outcome Measures

Name	Time	Method
Difference in post-operative opioid usage with the use of uterosacral ligament bupivacaine injection	7 days post-op	Total morphine equivalents of opioids in the first 7 days after surgery will be assessed to look for a statistically significant difference

Secondary Outcome Measures

Name	Time	Method
Difference in Visual analog scores (VAS) scores following uterosacral ligament bupivicaine injection	7 days post-op	Patient will report VAS scores daily until post-op day 7 on a scale of 1-10 with higher scores indicating higher pain severity. The investigators will be looking for a statistically significant difference between the treatment and placebo vs. sham group.
Time to first bowel movement following uterosacral ligament bupivicaine injection	7 days post-op	Patients will record when they resume normal bowel function on a pill diary post-operatively

Trial Locations

Locations (2)

Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States

Howard County General Hospital; 🇺🇸 Columbia, Maryland, United States