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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
PAINS Trial Summary
Preoperative Analgesia by Infiltration of the Pudendal Nerve Prior to Sacrospinous Ligament Suspension
Eligible Conditions
- Pelvic Organ Prolapse
PAINS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ measured at postoperative day 14
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured at postoperative day 14
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 morePAINS 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
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Who is running the clinical trial?
Fraser HealthLead Sponsor
45 Previous Clinical Trials
707,440 Total Patients Enrolled
Frequently Asked Questions
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