Actively Recruiting
Saddle Block With IT Morphine for Penile Inversion Vaginoplasty
Led by Women's College Hospital · Updated on 2025-08-13
40
Participants Needed
1
Research Sites
68 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 hypothesized that the addition of a saddle block with intrathecal morphine would yield clinically important analgesic benefits.
CONDITIONS
Official Title
Saddle Block With IT Morphine for Penile Inversion Vaginoplasty
Who Can Participate
Eligibility Criteria
You may qualify if you...
- ASA I-III patients
- Ages 18-70 years
- Undergoing Penile Inversion Vaginoplasty surgery
You will not qualify if you...
- Presence of local infection
- Use of over 30mg oxycodone or equivalent per day
- Contraindication to any component of multimodal analgesia
- Complications or adverse events unrelated to local anesthetic that prevent evaluation of outcomes
- Unable to speak or read English
- Revision and Vulvaplasty surgeries
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Women's College Hospital
Toronto, Ontario, Canada, M5S 1B2
Actively Recruiting
Research Team
D
Didem Bozak
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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