Opioid Use, Surgical Recovery, Vaginal Hysterectomy, Prolapse Pelvic, Postoperative Pain
Conditions
Keywords
paracervical block, vaginal hysterectomy, prolapse repair, postoperative opioid use, postoperative pain scores, postoperative recovery
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
Interventions
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
DRUGNormal 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
Sponsors
University of North Carolina, Chapel Hill
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Contacts
Primary ContactBertie Geng, MD
Backup ContactMarcella Willis-Gray, MD
Outcome results
None listed