Paracervical Injection and Opioid Use After Vaginal Hysterectomy for Prolapse

NCT07213635 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 25-0619
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

paracervical block; vaginal hysterectomy; prolapse repair; postoperative opioid use; postoperative pain scores; postoperative recovery

Outcome Measures

Primary Outcomes (1)

• Postoperative opioid use

  Mean postoperative opioid use converted to morphine milligram equivalents

  Assessed verbally during a 5 minute phone call on day 1 and 7 following surgery

Secondary Outcomes (4)

• Pain score

  Assessed verbally prior to discharge from post anesthesia recovery area, and during 5 minute phone call on day 1 and 7 following surgery

• Global Surgical Recovery score

  Assessed verbally during 5 minute phone call on day 1 and 7 following surgery.

• Postdischarge Surgical Recovery

  Assessed during completion of 5 minute survey on week 6 postoperative visit.

• Adverse events

  From day of surgery until week 6 postoperative visit

Study Arms (2)

Paracervical block

EXPERIMENTAL

Participants randomized to this experimental arm will receive a paracervical block with 0.5% bupivacaine with epinephrine at the time of vaginal hysterectomy with prolapse repair

Drug: Bupivacaine-epinephrine

Placebo

PLACEBO COMPARATOR

Participants randomized to this experimental arm will receive a placebo paracervical injection with normal saline at the time of vaginal hysterectomy with prolapse repair

Drug: Normal saline

Interventions

Bupivacaine-epinephrine DRUG

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

Paracervical block

Normal saline DRUG

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

Also known as: Placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals undergoing vaginal hysterectomy with concomitant prolapse repair procedure

You may not qualify if:

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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

University of North Carolina Urogynecology and Reconstructive Pelvic Surgery at REX

Raleigh, North Carolina, 27607, United States

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Bertie Geng, MD

  University of North Carolina

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bertie Geng, MD

CONTACT

984-974-0496; bertie.geng@unchealth.unc.edu

Marcella Willis-Gray, MD

CONTACT

Marcella_Willis-Gray@med.unc.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2025
• First Posted: October 9, 2025
• Study Start: October 20, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: October 24, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Time Frame: beginning 12 months following publication until 36 months following publication
• Access Criteria: Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.

Locations

US (1)