Paracervical Injection and Opioid Use After Vaginal Hysterectomy for Prolapse

NCT ID: NCT07213635

Last Updated: 2025-10-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-20
• Study Completion Date: 2026-12-31

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

Detailed Description

Secondary outcomes are to:

1. Compare postoperative pain scores in patients undergoing vaginal hysterectomy for prolapse repair who receive an intraoperative paracervical block compared to placebo

2. Compare surgical recovery times in patients undergoing vaginal hysterectomy for prolapse repair who receive an intraoperative paracervical block compared to placebo.

3. Examine incidence of adverse events in patients undergoing vaginal hysterectomy for prolapse repair who receive intraoperative paracervical block compared to placebo

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Paracervical block

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

Group Type: EXPERIMENTAL

Bupivacaine-epinephrine

Intervention Type: 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

Placebo

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

Group Type: PLACEBO_COMPARATOR

Normal saline

Intervention Type: 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

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

Placebo

Eligibility Criteria

Inclusion Criteria

• Individuals undergoing vaginal hysterectomy with concomitant prolapse repair procedure

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bertie Geng, MD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina

Locations

University of North Carolina Urogynecology and Reconstructive Pelvic Surgery at REX

Raleigh, North Carolina, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Bertie Geng, MD

Role: CONTACT

bertie.geng@unchealth.unc.edu

984-974-0496

Marcella Willis-Gray, MD

Role: CONTACT

Marcella_Willis-Gray@med.unc.edu

Facility Contacts

Bertie Geng, MD

Role: primary

bertie.geng@unchealth.unc.edu

984-974-0496

Marcella Willis-Gray, MD

Role: backup

Marcella_Willis-Gray@med.unc.edu

Other Identifiers

25-0619

Identifier Type: -

Identifier Source: org_study_id