Paracervical Injection and Opioid Use After Vaginal Hysterectomy for Prolapse
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Bupivacaine-epinephrine, Normal saline.
- Who it may be relevant to
- Registry conditions: Opioid Use, Surgical Recovery, Vaginal Hysterectomy, Prolapse Pelvic. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Paracervical Block on Postoperative Opioid Use in Vaginal Hysterectomy for Prolapse: a Randomized, Placebo-Controlled Trial
Overview
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
Interventions
- Drug 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 - 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
Primary outcome measures
- Postoperative opioid use [Time frame: Assessed verbally during a 5 minute phone call on day 1 and 7 following surgery]
Secondary outcome measures (4)
- 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]
- Global Surgical Recovery score [Time frame: Assessed verbally during 5 minute phone call on day 1 and 7 following surgery.]
- Postdischarge Surgical Recovery [Time frame: Assessed during completion of 5 minute survey on week 6 postoperative visit.]
- Adverse events [Time frame: From day of surgery until week 6 postoperative visit]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
United States · 1 center
- University of North Carolina Urogynecology and Reconstructive Pelvic Surgery at REX — Raleigh
Identifiers
NCT: NCT07213635 · 25-0619