Clinical trial NCT06556121: Saddle Block With IT Morphine for Penile Inversion Vaginoplasty
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pain, Postoperative
Keywords: Saddle block
transition
pudendal nerve block
gender confirmation surgery
penile inversion Vaginoplasty
Lead sponsor: Women's College Hospital
Sponsor class: OTHER
First posted: 2024-08-15
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, parallel-group, double-blind
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Cumulative opioid (analgesic) consumption
timeFrame: 48 hours
Secondary outcomes:
measure: Time to first analgesic request
timeFrame: 24 hours
measure: Pain Assessment (VAS)
timeFrame: Up to 48 hours post-operatively
measure: Incidence of opioid-related side effects
timeFrame: Up to 48 hours post-operatively
measure: Presence of Block-related complications
timeFrame: Up to 48 hours post-operatively
measure: Quality of Life scores
timeFrame: 48 hours post-operatively
measure: Patient Satisfaction with Analgesic Technique and Pain management
timeFrame: 24 hours post-operatively
Other outcomes:
Locations:
Study officials:
affiliation: Women's College Hospital
name: Richard Brull, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Women's College Hospital
name: Laura Giron-Arango, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Swisher MW, Dolendo IM, Sztain JF, Alexander BS, Tsuda PS, Anger JT, Said ET. Intrathecal Morphine Injection for Postoperative Analgesia Following Gender-Affirming Pelvic Surgery: A Retrospective Case-Control Study. Cureus. 2023 Mar 27;15(3):e36748. doi: 10.7759/cureus.36748. eCollection 2023 Mar.
citation: Yung EM, Abdallah FW, Todaro C, Spence E, Grant A, Brull R. Optimal local anesthetic regimen for saddle block in ambulatory anorectal surgery: an evidence-based systematic review. Reg Anesth Pain Med. 2020 Sep;45(9):733-739. doi: 10.1136/rapm-2020-101603. Epub 2020 Jul 22.
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citation: Shim JW, Cho YJ, Moon HW, Park J, Lee HM, Kim YS, Moon YE, Hong SH, Chae MS. Analgesic efficacy of intrathecal morphine and bupivacaine during the early postoperative period in patients who underwent robotic-assisted laparoscopic prostatectomy: a prospective randomized controlled study. BMC Urol. 2021 Feb 26;21(1):30. doi: 10.1186/s12894-021-00798-4.
citation: Chin P, Yuan N, Zaliznyak M, Stelmar J, Garcia M. Effectiveness of Pudendal Nerve Blocks on Postoperative Pain Control and Reduction in Opioid Usage after Gender-affirming Vaginoplasty. The Journal of Sexual Medicine. 2022;19(4, Supplement 1):S79. doi:10.1016/j.jsxm.2022.01.166