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NCT Number: NCT06556121

Saddle Block With IT Morphine for Penile Inversion Vaginoplasty

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.

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Key information

Age range

18 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Women's College Hospital

Toronto, Ontario, M5S 1B2, Canada

Location status: Recruiting

Location contact

Didem Bozak

CONTACT

[email protected]

416-323-6008

About this study

PIV is a TRS offered for male-to-female transition associated with severe postoperative pain despite contemporary analgesic strategies, including opioid-based multimodal systemic analgesia and local anesthetic-based pudendal nerve block. Intrathecal opioids directly target the nociceptors in the spinal cord and can provide potent analgesia for abdominopelvic procedures, including PIV, but are associated with important dose-related adverse effects with rostral spread within the cerebrospinal fluid.

Motor-sparing saddle block using ultra-low dose hyperbaric spinal anesthesia has been successfully implemented as the standard of care for anesthesia in patients undergoing ambulatory perianal procedures at WCH. Saddle block produces reliable sensory anesthesia and long-lasting analgesia of the perineum ("saddle") as the hyperbaric local anesthetic preferentially blocks the small pain fibers of the sacral nerve roots with gravity when the patient is placed in the seated position. With the aim to directly target the opioid nociceptors in the sacral roots and limit rostral opioid spread (and associated opioid-related adverse effects), we recently began to offer a presurgical saddle block with a low dose of intrathecal morphine (100mcg) to patients undergoing PIV at WCH with excellent anecdotal results. Therefore, we are undertaking the present randomized placebo-controlled study to determine whether or not the addition of a saddle block with IT morphine to multimodal systemic analgesia and surgeon-administered pudendal nerve block provides superior analgesia to multimodal systemic analgesia and surgeon-administered pudendal nerve block alone.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

saddle block

Procedure

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

Procedure

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.

Primary outcomes

  1. Cumulative opioid (analgesic) consumption

    Time frame: 48 hours

    Consumption intra-operatively, total in-hospital postoperative consumption measured oral morphine equivalents (MEQ)

Secondary outcomes

  1. Time to first analgesic request

    Time frame: 24 hours

    At recovery room discharge and hospital discharge

  2. Pain Assessment (VAS)

    Time frame: Up to 48 hours post-operatively

    Visual Analogue Scale(VAS) - Pain:Overall pain assessed at rest and on movement A continuous scale comprised of a 100mm (10cm) horizontal line, anchored by 2 verbal descriptions No Pain to Worst Pain

  3. Incidence of opioid-related side effects

    Time frame: Up to 48 hours post-operatively

    Itching, respiratory depression, hypotension, nausea and vomiting

  4. Presence of Block-related complications

    Time frame: Up to 48 hours post-operatively

    Persistent paresthesia, post dural puncture headache

  5. Quality of Life scores

    Time frame: 48 hours post-operatively

    Quality of Recovery (QR15) scores at 48 hours will be the second primary outcome.

    QR15 is a measurement of quality of recovery after surgery and anesthesia that has been psychometrically tested and validated. Reporting of outcome measures on a scale of 0 to 10 (0=None of the time and 10=All of the time). There are a total of 40 items/questions.

  6. Patient Satisfaction with Analgesic Technique and Pain management

    Time frame: 24 hours post-operatively

    A Patient Diary will be completed to assess overall satisfaction with analgesic technique

Study contacts

Contact information is provided by the study sponsor or research team.

Didem Bozak

CONTACT

[email protected]

416-323-6008

Sponsors and collaborators

Lead sponsor

Women's College Hospital

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 15, 2024
Registry last updated
Aug 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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