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OpenTrials
Active, not recruiting

NCT Number: NCT07213635

Paracervical Injection and Opioid Use After Vaginal Hysterectomy for Prolapse

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

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Opioid Use Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Pain Prolapse Pelvic Signs and Symptoms Surgical Recovery Vaginal Hysterectomy

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

University of North Carolina Urogynecology and Reconstructive Pelvic Surgery at REX

Raleigh, North Carolina, 27607, United States

About this study

Secondary outcomes are to:

  • Compare postoperative pain scores in patients undergoing vaginal hysterectomy for prolapse repair who receive an intraoperative paracervical block compared to placebo
  • Compare surgical recovery times in patients undergoing vaginal hysterectomy for prolapse repair who receive an intraoperative paracervical block compared to placebo.
  • Examine incidence of adverse events in patients undergoing vaginal hysterectomy for prolapse repair who receive intraoperative paracervical block compared to placebo

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Other names: Placebo

Primary outcomes

  1. Postoperative opioid use

    Time frame: 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 outcomes

  1. Pain score

    Time frame: 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"

  2. Global Surgical Recovery score

    Time frame: 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.

  3. Postdischarge Surgical Recovery

    Time frame: 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.

  4. Adverse events

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Registry information

Official study title

Effect of Paracervical Block on Postoperative Opioid Use in Vaginal Hysterectomy for Prolapse: a Randomized, Placebo-Controlled Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 9, 2025
Registry last updated
Aug 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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