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Bupivacaine Injectable Product for Pelvic Organ Prolapse (PAINS Trial)

N/A
Waitlist Available
Research Sponsored by Fraser Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured at postoperative day 14
Awards & highlights

Summary

Pelvic organ prolapse is a common problem. It affects about half of women and causes uncomfortable bulge sensations (similar to sitting on a ball), urine and stool problems, difficulty with sexual activity and embarrassment. Almost one of every five women undergoes surgery to treat prolapse.Typically, vaginal surgery is done while patients are asleep and local anesthetic- freezing medication- is injected where incisions are made to minimize the pain from surgery when waking up. Pudendal blocks are nerve blocks where local anesthetic is used to freeze a nerve that supplies sensation to the vulva and vaginal area. It is traditionally used to help with pain for women giving birth, but hasn't been studied well in women undergoing vaginal surgery for prolapse. The investigators believe that by using a small amount of freezing to provide a pudendal block at the time of surgery, on top of the freezing typically provided, that there will be minimized pain after surgery and improve the recovery process. Based on previous studies using pudendal blocks for different vulvar and vaginal procedures, the investigators believe this to be a safe and potentially beneficial practice. The investigators are planning to conduct a randomized controlled trial of 50 women. 25 will receive pudendal nerve blocks at the time of surgery, and 25 will receive placebo injections.The investigators will monitor their pain scores, satisfaction, use of pain medications and return to activities in order to determine if our intervention has caused a significant improvement in recovery.

Eligible Conditions
  • Pelvic Organ Prolapse

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured at postoperative day 14
This trial's timeline: 3 weeks for screening, Varies for treatment, and measured at postoperative day 14 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Post-operative Pain Score
Secondary study objectives
Functional Recovery Index
Patient satisfaction
Post-operative Analgesic use
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Pudendal nerve blockExperimental Treatment2 Interventions
25 women will receive pudendal nerve blocks of 0.25% Bupivicaine 10ml administered vaginally prior to making any surgical incisions.
Group II: PlaceboPlacebo Group1 Intervention
25 women will receive sham pudendal nerve blocks using normal saline. These will also be administed vaginally prior to making any surgical incisions.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pudendal nerve block
2016
N/A
~1200

Find a Location

Who is running the clinical trial?

Fraser HealthLead Sponsor
46 Previous Clinical Trials
707,540 Total Patients Enrolled
~11 spots leftby Sep 2025