Paracervical Injection and Opioid Use After Vaginal Hysterectomy for Prolapse

Part of paid clinical trials in Raleigh, North Carolina.

Sponsor
University of North Carolina, Chapel Hill
Study ID
NCT07213635
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

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
  • 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

Study Details

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

Key Dates

Start date
Oct 20, 2025
Status verified
Oct 2025
Primary completion
Oct 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
56 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: 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
  • Placebo Comparator: 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

Primary Outcome Measure

Postoperative opioid use [ Time Frame: Assessed verbally during a 5 minute phone call on day 1 and 7 following surgery ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of North Carolina Urogynecology and Reconstructive Pelvic Surgery at REXRaleighNorth Carolina27607
Bertie Geng, MD
[email protected]
984-974-0496
Marcella Willis-Gray, MD
[email protected]
Bertie Geng, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Raleigh, NC

By condition
Substance use disorder
By specialty
Behavioral healthAddiction medicine
By research site
University of North Carolina Urogynecology and Reconstructive Pelvic Surgery at REX· Raleigh, NC

Related Studies