Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
MALE
NCT06556121

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

Age: 18Years - 70Years
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • ASA I-III patients
  • Ages 18-70 years
  • Undergoing Penile Inversion Vaginoplasty surgery
Not Eligible

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

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Women's College Hospital

Toronto, Ontario, Canada, M5S 1B2

Actively Recruiting

Loading map...

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

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here