Recruiting

Saddle Block with Morphine

Sponsor:

Women's College Hospital

Code:

NCT06556121

Conditions

Pain, Postoperative

Eligibility Criteria

Sex: Male

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Saddle block

pudendal nerve block

Study Details

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.

Conditions

Pain, Postoperative

Study ID

NCT06556121

Start date

Aug 7, 2025

Status verified date

Aug, 2025

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18 - 70

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Saddle block with intrathecal morphine Group

Patients will receive a multimodal analgesic regimen with acetaminophen, NSAIDs and opioids plus a surgeon-administered pudendal nerve block by anatomical landmarks with 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.

Patients who are randomized to the saddle block with intrathecal morphine will receive an injection of 5mg of heavy Bupivacaine 0.75% plus 100mcg of morphine injected in the intrathecal space.

sham comparator: Control Group

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 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.

Patients in this group will receive a non-invasive sham saddle block in addition to the care standard.

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.

Primary outcome measure

  • Cumulative opioid (analgesic) consumption [ Time Frame: 48 hours ]

Central Contacts and Locations

Central contacts

Locations

Women's College Hospital

Recruiting

Toronto, Ontario, Canada, M5S 1B2

Contacts

More Information

Sponsor

Women's College Hospital

Last update posted

Aug 13, 2025

Last verified

Aug, 2025

Keywords

  • Saddle block
  • transition
  • pudendal nerve block
  • gender confirmation surgery
  • penile inversion Vaginoplasty

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Women's College Hospital on 2025-08-13.