Paracervical Injection and Opioid Use After Vaginal Hysterectomy for Prolapse

Not Applicable

Not yet recruiting

• Conditions: Opioid Use; Surgical Recovery; Vaginal Hysterectomy; Prolapse Pelvic; Postoperative Pain
• Interventions: Drug: Bupivacaine-epinephrine; Drug: Normal saline

• Registration Number: NCT07213635
• Lead Sponsor: University of North Carolina, Chapel Hill

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

Study Timeline

• Status Verified: 2025-10
• Study Start: 2025-10-01
• Study First Submitted: 2025-10-02
• Study First Submitted QC: 2025-10-02
• Last Update Submitted: 2025-10-02
• Study First Posted: 2025-10-09
• Last Update Posted: 2025-10-09
• Primary Completion: 2026-10
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 56

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Paracervical block	Bupivacaine-epinephrine	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
Placebo	Normal saline	Participants randomized to this experimental arm will receive a placebo paracervical injection with normal saline at the time of vaginal hysterectomy with prolapse repair

Primary Outcome Measures

Name	Time	Method
Postoperative opioid use	Assessed verbally during a 5 minute phone call on day 1 and 7 following surgery	Mean postoperative opioid use converted to morphine milligram equivalents

Secondary Outcome Measures

Name	Time	Method
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	Mean numeric visual analog pain score from 0-10 where 0 is "no pain" and 10 is "worst pain you can imagine"
Global Surgical Recovery score	Assessed verbally during 5 minute phone call on day 1 and 7 following surgery.	Mean Global Surgical Recovery score (from 0-100%) where 0% is not recovered at all and 100% is fully recovered.
Postdischarge Surgical Recovery	Assessed during completion of 5 minute survey on week 6 postoperative visit.	Mean Postdischarge Surgical Recovery score (from 0-100) where higher scores denote better recovery.
Adverse events	From day of surgery until week 6 postoperative visit	Number of hospital admission (including on day of surgery) and emergency department presentations as well as additional calls or urgent clinic visits

Trial Locations

Locations (1)

University of North Carolina Urogynecology and Reconstructive Pelvic Surgery at REX; 🇺🇸 Raleigh, North Carolina, United States