RecruitingNot ApplicableNCT06556121

Saddle Block With IT Morphine for Penile Inversion Vaginoplasty

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

Sponsor

Women's College Hospital

Enrollment

40 participants

Start Date

Aug 7, 2025

Study Type

INTERVENTIONAL

Conditions

Pain, Postoperative

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

Sex: MALEMin Age: 18 YearsMax Age: 70 Years

Inclusion Criteria3

ASA I-III patients
Ages 18-70 years
Penile Inversion Vaginoplasty

Exclusion Criteria6

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

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Interventions

PROCEDURESaddle 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.

PROCEDUREpudendal 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.