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

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.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative; Opioid Use
• Intervention / Treatment: Drug: Bupivacaine

• Study Type: Interventional
• Enrollment (Actual): 180
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins Hospital
    • Columbia, Maryland, United States, 21044
      • Howard County General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: No injection; No injection will be performed	Drug: Bupivacaine; Bupivicaine injection into uterosacral ligaments prior to colpotomy
Sham Comparator: Normal Saline Injection; Normal saline will be injected into the uterosacral ligaments prior to colpotomy	Drug: Bupivacaine; Bupivicaine injection into uterosacral ligaments prior to colpotomy
Active Comparator: Bupivacaine Injection; Bupivacaine will be injected into the uterosacral ligaments prior to colpotomy	Drug: Bupivacaine; Bupivicaine injection into uterosacral ligaments prior to colpotomy

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in Visual analog scores (VAS) scores following uterosacral ligament bupivicaine injection	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.	7 days post-op
Time to first bowel movement following uterosacral ligament bupivicaine injection	Patients will record when they resume normal bowel function on a pill diary post-operatively	7 days post-op

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Investigators: Principal Investigator: Karen Wang, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2021
• Primary Completion (Actual): October 15, 2022
• Study Completion (Actual): October 15, 2022

Study Registration Dates

• First Submitted: November 6, 2019
• First Submitted That Met QC Criteria: November 7, 2019
• First Posted (Actual): November 8, 2019

Study Record Updates

• Last Update Posted (Actual): November 9, 2022
• Last Update Submitted That Met QC Criteria: November 7, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: IRB00221267

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No