Status:
UNKNOWN
Preoperative Analgesia by Infiltration of the Pudendal Nerve Prior to Sacrospinous Ligament Suspension
Lead Sponsor:
Fraser Health
Conditions:
Pelvic Organ Prolapse
Eligibility:
FEMALE
19+ years
Phase:
NA
Brief 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 act...
Detailed Description
Study Procedures: Randomization and Blinding: Women will be randomized to receive either Bupivacaine 0.25% or Normal Saline pudendal injections based on the label within a sealed envelope randomly s...
Eligibility Criteria
Inclusion
- Over 18 years of age
- Diagnosed with prolapse and planning to undergo vaginal day surgery as treatment.
- 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.
- Able to read and write in English
- Able to complete email surveys for the first 2 weeks after surgery
Exclusion
- Those with an allergy to local anesthetic (freezing injections)
- Those who prefer to have surgery under spinal anesthesia
- Those with planned concurrent vulvar, laparoscopic or abdominal surgery, or any planned concurrent vaginal surgery other than those in the inclusion criteria.
- Those with a pre-existing chronic pain disorder requiring the regular use of opioid analgesics (more than twice weekly)
- Those with a history of substance abuse
- Those with a history of bleeding disorder
- Those who would prefer not to participate in the study,
- If unable to receive emails in order to fill out the surveys.
- Inability to provide informed consent
- Currently enrolled in any other research study involving drugs or devices
Key Trial Info
Start Date :
April 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2022
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04733560
Start Date
April 1 2021
End Date
June 1 2022
Last Update
October 12 2021
Active Locations (1)
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1
City Centre Obstetrics and Gynecology
Surrey, British Columbia, Canada, V3V 0C6