Saddle Block With IT Morphine for Penile Inversion Vaginoplasty

Recruiting now · Not applicable

Conditions studied: Pain, Postoperative

In brief

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.

Key facts

Study ID

NCT06556121

Run by

Women's College Hospital

People needed

40

Starts

2025-08-07

Expected to finish

2026-12-01

Last updated by the study team

2025-08-13

Who can join

Age: 18 and older, up to 70. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• ASA I-III patients
• Ages 18-70 years
• Penile Inversion Vaginoplasty

You may not qualify if…

• 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

Where it is running

• Women's College Hospital — Toronto, Ontario, Canada (enrolling)

Full record on ClinicalTrials.gov

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