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
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
56
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
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
University of North Carolina Urogynecology and Reconstructive Pelvic Surgery at REX
Raleigh, North Carolina, United States
RECRUITINGPostoperative opioid use
Mean postoperative opioid use converted to morphine milligram equivalents
Time frame: Assessed verbally during a 5 minute phone call on day 1 and 7 following surgery
Pain score
Mean numeric visual analog pain score from 0-10 where 0 is "no pain" and 10 is "worst pain you can imagine"
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
Mean Global Surgical Recovery score (from 0-100%) where 0% is not recovered at all and 100% is fully recovered.
Time frame: Assessed verbally during 5 minute phone call on day 1 and 7 following surgery.
Postdischarge Surgical Recovery
Mean Postdischarge Surgical Recovery score (from 0-100) where higher scores denote better recovery.
Time frame: Assessed during completion of 5 minute survey on week 6 postoperative visit.
Adverse events
Number of hospital admission (including on day of surgery) and emergency department presentations as well as additional calls or urgent clinic visits
Time frame: From day of surgery until week 6 postoperative visit
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