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Saddle Block With IT Morphine for Penile Inversion Vaginoplasty
Sponsor: Women's College Hospital
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.
Official title: The Addition of a Saddle Block With Intrathecal Morphine for Analgesia in Transgender Patients Undergoing Penile Inversion Vaginoplasty: A Randomized Double-blind Placebo-controlled Trial
Key Details
Gender
MALE
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2025-08-07
Completion Date
2026-12
Last Updated
2025-08-13
Healthy Volunteers
No
Conditions
Interventions
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.
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.
Locations (1)
Women's College Hospital
Toronto, Ontario, Canada