Actively Recruiting

Phase 4
Age: 18Years +
FEMALE
Healthy Volunteers
NCT07213635

Paracervical Injection and Opioid Use After Vaginal Hysterectomy for Prolapse

Led by University of North Carolina, Chapel Hill · Updated on 2025-10-24

56

Participants Needed

1

Research Sites

58 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The goal of the study to see if giving a numbing medicine around the cervix (called a paracervical block) during vaginal hysterectomy with prolapse repair helps people feel less pain and need fewer strong pain medicines afterward. The main question it aims to answer is: • Does receiving a paracervical block at the time of vaginal hysterectomy with prolapse repair reduce postoperative opioid use? Researchers will compare opioid use in participants who receive the an injected numbing medicine (bupivacaine with lidocaine) to those that receive a saltwater liquid placebo. Participants will: * Receive either an injection of the numbing medicine (bupivacaine with lidocaine) or saltwater liquid placebo after they are asleep but before any other parts of the surgery are done * Record and report pain medications used for 7 days after surgery * Report pain scores before discharge from the post anesthesia recovery area on day of surgery as well as 1 and 7 days after surgery * Complete a surgical recovery questionnaire during 6 week postoperative visit * Complete a one page multiple-choice test on pelvic organ prolapse

CONDITIONS

Official Title

Paracervical Injection and Opioid Use After Vaginal Hysterectomy for Prolapse

Who Can Participate

Age: 18Years +
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Individuals undergoing vaginal hysterectomy with concomitant prolapse repair procedure
Not Eligible

You will not qualify if you...

  • Non-English speaking
  • Weight less than 50 kg
  • Allergy to bupivacaine
  • Pregnant

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of North Carolina Urogynecology and Reconstructive Pelvic Surgery at REX

Raleigh, North Carolina, United States, 27607

Actively Recruiting

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Research Team

B

Bertie Geng, MD

CONTACT

M

Marcella Willis-Gray, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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