Saddle Block With IT Morphine for Penile Inversion Vaginoplasty

NARecruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

August 7, 2025

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2026

Conditions
Pain, Postoperative
Interventions
PROCEDURE

Saddle block

The injected solution will be comprised of 5mg of heavy Bupivacaine 0.75% plus 100mcg of Morphine will be injected into the intrathecal space.

PROCEDURE

pudendal nerve block

As part of the analgesic plan, all patients will receive a multimodal analgesic regimen with acetaminophen, NSAIDs and opioids plus a surgeon-administered pudendal nerve block by anatomical landmarks with a mixture of Local Anesthetic as follows: 50mL of Normal Saline, 30mL of 0.25% Bupivacaine with epinephrine 1:200.000 and 20mL Lidocaine 1%. A volume of 20 mL of this mixture is used for the pudendal nerve block, and infiltration of the surgical incision and bilateral spermatic cord block is performed with an additional 20 mL of the same mixture of local anesthetic. 30ml of the solution is used to soak the vaginal plug made of gauze that is put inside the vaginal canal by the end of the procedure.

Trial Locations (1)

M5S 1B2

RECRUITING

Women's College Hospital, Toronto

All Listed Sponsors
lead

Women's College Hospital

OTHER

NCT06556121 - Saddle Block With IT Morphine for Penile Inversion Vaginoplasty | Biotech Hunter | Biotech Hunter