Paracervical Injection and Opioid Use After Vaginal Hysterectomy for Prolapse
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of North Carolina, Chapel Hill
About this trial
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
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Individuals undergoing vaginal hysterectomy with concomitant prolapse repair procedure
Disqualifiers
Non-English speaking
Weight less than 50 kg
Allergy to bupivacaine
Pregnant
Trial design
Design model
Parallel
Treatments tested in this trial
Bupivacaine-epinephrine
DrugParticipants 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
DrugParticipants 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
Treatment groups
56 Participants
are divided into 2 treatment groupsGroup A: Paracervical blockExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Postoperative 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 surgerySecondary outcomes
1
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 surgery2
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.3
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.4
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 visitSponsors and contacts
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Source ClinicalTrials.gov