Pain, PostoperativeNCT06556121
Saddle Block With IT Morphine for Penile Inversion Vaginoplasty
A study testing Saddle block and pudendal nerve block in people with Pain, Postoperative, run by Women's College Hospital at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, men only
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Saddle block and pudendal nerve block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 7 Aug 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I-III patients
- Ages 18-70 years
- Penile Inversion Vaginoplasty
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Women's College Hospital
Toronto, Ontario, M5S 1B2
Didem Bozak, 416-323-6008, didem.bozak@wchospital.ca
About this study
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
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.
Read the 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.
- Conditions
- Pain, Postoperative
- Being tested
- Saddle block, pudendal nerve block
- Keywords
- Saddle block, transition, pudendal nerve block, gender confirmation surgery, penile inversion Vaginoplasty
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saddle blockProcedure or surgery
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 blockProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Saddle block; Procedure: pudendal nerve block |
| 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. Receives: Procedure: pudendal nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative opioid (analgesic) consumption
Consumption intra-operatively, total in-hospital postoperative consumption measured oral morphine equivalents (MEQ)
Measured: 48 hours
Secondary outcomes (6)
Time to first analgesic request
At recovery room discharge and hospital discharge
Measured: 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
Measured: Up to 48 hours post-operatively
Incidence of opioid-related side effects
Itching, respiratory depression, hypotension, nausea and vomiting
Measured: Up to 48 hours post-operatively
Presence of Block-related complications
Persistent paresthesia, post dural puncture headache
Measured: 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.
Measured: 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
Measured: 24 hours post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2024
- Study start7 Aug 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, parallel-group, double-blind
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Women's College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard Brull, MD, Principal investigator, Women's College HospitalLaura Giron-Arango, MD, Principal investigator, Women's College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06556121
- Sponsor's protocol ID
- 2024-0061-B
- Status last verified
- Aug 2025
- First submitted
- 13 Aug 2024
- Last updated
- 13 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37123779Yung 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.
PubMed 32699103Hein 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.
PubMed 22150410DI 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.
PubMed 34851074Shim 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.
PubMed 33637066Chin 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
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06556121
- Acronym / sponsor ID
- 2024-0061-B
- Conditions
- Pain, Postoperative
- Keywords
- Saddle block, transition, pudendal nerve block, gender confirmation surgery, penile inversion Vaginoplasty
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Women's College HospitalUniversity, hospital or other
- Study start
- 7 Aug 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 15 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Randomized, parallel-group, double-blind
| Arm | Type | Receives |
|---|---|---|
| Saddle block with intrathecal morphine Group | Experimental | Procedure: Saddle block, Procedure: pudendal nerve blockPatients 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. |
| Control Group | Sham comparator | Procedure: pudendal nerve blockAs 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA I-III patients
- Ages 18-70 years
- Penile Inversion Vaginoplasty
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Saddle blockThe injected solution will be comprised of 5mg of heavy Bupivacaine 0.75% plus 100mcg of Morphine will be injected into the intrathecal space. | Procedure or surgery | Saddle block with intrathecal morphine Group |
| pudendal nerve blockAs 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. | Procedure or surgery | Control Group, Saddle block with intrathecal morphine Group |
Primary outcome
Cumulative opioid (analgesic) consumption
Time frame: 48 hours
Consumption intra-operatively, total in-hospital postoperative consumption measured oral morphine equivalents (MEQ)
6 secondary outcomes
Time to first analgesic request
Time frame: 24 hours
Pain Assessment (VAS)
Time frame: Up to 48 hours post-operatively
Incidence of opioid-related side effects
Time frame: Up to 48 hours post-operatively
Presence of Block-related complications
Time frame: Up to 48 hours post-operatively
Quality of Life scores
Time frame: 48 hours post-operatively
Patient Satisfaction with Analgesic Technique and Pain management
Time frame: 24 hours post-operatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2025.
- Background: PubMed 37123779Swisher 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.
- Background: PubMed 32699103Yung 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.
- Background: PubMed 22150410Hein 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.
- Background: PubMed 34851074DI 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.
- Background: PubMed 33637066Shim 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.
- BackgroundChin 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
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Richard Brull, MD principal investigator
Women's College Hospital
Laura Giron-Arango, MD principal investigator
Women's College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Saddle block and pudendal nerve block in people with Pain, Postoperative, run by Women's College Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Didem Bozak (416-323-6008, didem.bozak@wchospital.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative opioid (analgesic) consumption (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06556121, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2025.