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Intra-operative Uterosacral Ligament Bupivacaine Injection During Minimally Invasive Hysterectomy

NCT04157075 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2022-11-09

No results posted yet for this study

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

DRUG

Bupivacaine

Bupivicaine injection into uterosacral ligaments prior to colpotomy

Sponsors & Collaborators

Principal Investigators

  • Karen Wang · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-03-15
Primary Completion
2022-10-15
Completion
2022-10-15
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04157075 on ClinicalTrials.gov