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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
Over 18 years of age
Must be undergoing a sacrospinous ligament fixation as part of their procedure. Those undergoing a concurrent anterior and/or posterior vaginal repair, or mid-urethral sling will also be included.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured at postoperative day 14
Awards & highlights

PAINS Trial Summary

Preoperative Analgesia by Infiltration of the Pudendal Nerve Prior to Sacrospinous Ligament Suspension

Eligible Conditions
  • Pelvic Organ Prolapse

PAINS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

PAINS Trial 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

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

PAINS 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
45 Previous Clinical Trials
707,440 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~12 spots leftby Apr 2025