NCT06556121 Saddle Block With IT Morphine for Penile Inversion Vaginoplasty
| NCT ID | NCT06556121 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Women's College Hospital |
| Condition | Pain, Postoperative |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-08-07 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2025-08-07 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 hypothesized that the addition of a saddle block with intrathecal morphine would yield clinically important analgesic benefits.
Eligibility Criteria
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
Contact & Investigator
Richard Brull, MD
PRINCIPAL INVESTIGATOR
Women's College Hospital
Frequently Asked Questions
Who can join the NCT06556121 clinical trial?
This trial is open to male participants only, aged 18 Years or older, up to 70 Years, studying Pain, Postoperative. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06556121 currently recruiting?
Yes, NCT06556121 is actively recruiting participants. Contact the research team at didem.bozak@wchospital.ca for enrollment information.
Where is the NCT06556121 trial being conducted?
This trial is being conducted at Toronto, Canada.
Who is sponsoring the NCT06556121 clinical trial?
NCT06556121 is sponsored by Women's College Hospital. The principal investigator is Richard Brull, MD at Women's College Hospital. The trial plans to enroll 40 participants.