RecruitingNot Applicable

Saddle Block With IT Morphine for Penile Inversion Vaginoplasty

Canada40 participantsStarted 2025-08-07

Plain-language 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 hypothesized that the addition of a saddle block with intrathecal morphine would yield clinically important analgesic benefits.

Who can participate

Age range18 Years – 70 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * ASA I-III patients * Ages 18-70 years * Penile Inversion Vaginoplasty Exclusion Criteria: * 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

What they're measuring

Cumulative opioid (analgesic) consumption

Timeframe: 48 hours

Trial details

NCT IDNCT06556121

SponsorWomen's College Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12

Contact for this trial

Didem Bozak

416-323-6008 didem.bozak@wchospital.ca

View on ClinicalTrials.gov More Pain, Postoperative trials