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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Saddle block with intrathecal morphine Group | Experimental | 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. |
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| Control Group | Sham Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative opioid (analgesic) consumption | Consumption intra-operatively, total in-hospital postoperative consumption measured oral morphine equivalents (MEQ) | 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Time to first analgesic request | At recovery room discharge and hospital discharge | 24 hours |
| Pain Assessment (VAS) | 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 |
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Inclusion Criteria:
Exclusion Criteria:
male-to-female transitioning patient
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Didem Bozak | Contact | 416-323-6008 | didem.bozak@wchospital.ca |
| Name | Affiliation | Role |
|---|---|---|
| Richard Brull, MD | Women's College Hospital | Principal Investigator |
| Laura Giron-Arango, MD | Women's College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Women's College Hospital | Recruiting | Toronto | Ontario | M5S 1B2 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37123779 | Background | 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. | |
| 32699103 | Background |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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Randomized, parallel-group, double-blind
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Patient, anesthesiologist in the operating room
| 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. |
|
| Up to 48 hours post-operatively |
| Incidence of opioid-related side effects | Itching, respiratory depression, hypotension, nausea and vomiting | Up to 48 hours post-operatively |
| Presence of Block-related complications | Persistent paresthesia, post dural puncture headache | Up to 48 hours post-operatively |
| Quality of Life scores | 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. | 48 hours post-operatively |
| Patient Satisfaction with Analgesic Technique and Pain management | A Patient Diary will be completed to assess overall satisfaction with analgesic technique | 24 hours post-operatively |
| 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. |
| 22150410 | Background | Hein A, Rosblad P, Gillis-Haegerstrand C, Schedvins K, Jakobsson J, Dahlgren G. Low dose intrathecal morphine effects on post-hysterectomy pain: a randomized placebo-controlled study. Acta Anaesthesiol Scand. 2012 Jan;56(1):102-9. doi: 10.1111/j.1399-6576.2011.02574.x. |
| 34851074 | Background | DI Filippo A, Capezzuoli T, Fambrini M, Cariti G, Orlandi G, Vannucci G, Borracci T, DI Nallo L, Mazzella M, Petraglia F. Enhanced recovery after gynecological surgery: comparison between intrathecal and intravenous morphine multimodal analgesia. Minerva Obstet Gynecol. 2023 Apr;75(2):145-149. doi: 10.23736/S2724-606X.21.04961-7. Epub 2021 Dec 1. |
| 33637066 | Background | 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. |
| Background | 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 |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |