Status:
RECRUITING
Saddle Block With IT Morphine for Penile Inversion Vaginoplasty
Lead Sponsor:
Women's College Hospital
Conditions:
Pain, Postoperative
Eligibility:
MALE
18-70 years
Phase:
NA
Brief Summary
Penile Inversion Vaginoplasty (PIV) is a transition-related surgery (TRS) that is associated with severe postoperative pain. The optimal pain management strategies for this surgery remain unknown. We ...
Detailed Description
PIV is a TRS offered for male-to-female transition associated with severe postoperative pain despite contemporary analgesic strategies, including opioid-based multimodal systemic analgesia and local a...
Eligibility Criteria
Inclusion
- ASA I-III patients
- Ages 18-70 years
- Penile Inversion Vaginoplasty
Exclusion
- Local infection
- History of use of over 30mg oxycodone or equivalent per day.
- Contraindication to a component of multi-modal analgesia
- Complications or adverse events unrelated to the local anesthetic that precludes evaluation of the primary and secondary outcome measures.
- Unable to speak or read English.
- Revision and Vulvaplasty surgeries
Key Trial Info
Start Date :
August 7 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06556121
Start Date
August 7 2025
End Date
December 1 2026
Last Update
August 13 2025
Active Locations (1)
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1
Women's College Hospital
Toronto, Ontario, Canada, M5S 1B2