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Paracervical Injection and Opioid Use After Vaginal Hysterectomy for Prolapse

NCT07213635 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2025-10-24

No results posted yet for this study

Summary

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

  • Opioid Use
  • Surgical Recovery
  • Vaginal Hysterectomy
  • Prolapse Pelvic
  • Postoperative Pain

Interventions

DRUG

Bupivacaine-epinephrine

Participants randomized to this experimental arm will receive a paracervical block with 10 mL 0.5% bupivacaine with epinephrine before their vaginal hysterectomy and prolapse repair

DRUG

Normal saline

Participants randomized to this experimental arm will receive a placebo paracervical injection with 10 mL 0.5% normal saline before their vaginal hysterectomy and prolapse repair

Sponsors & Collaborators

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Bertie Geng, MD · University of North Carolina

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-10-20
Primary Completion
2026-10-31
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT07213635 on ClinicalTrials.gov