Pain, Postoperative
Conditions
Keywords
Saddle block, transition, pudendal nerve block, gender confirmation surgery, penile inversion Vaginoplasty
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.
Interventions
PROCEDURESaddle 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.
PROCEDUREpudendal 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.
Sponsors
Women's College Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Patient, anesthesiologist in the operating room
Intervention model description
Randomized, parallel-group, double-blind
Eligibility
Sex/Gender
MALE
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative opioid (analgesic) consumption | 48 hours | Consumption intra-operatively, total in-hospital postoperative consumption measured oral morphine equivalents (MEQ) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Assessment (VAS) | 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 |
| Incidence of opioid-related side effects | Up to 48 hours post-operatively | Itching, respiratory depression, hypotension, nausea and vomiting |
| Time to first analgesic request | 24 hours | At recovery room discharge and hospital discharge |
| Quality of Life scores | 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. |
| Patient Satisfaction with Analgesic Technique and Pain management | 24 hours post-operatively | A Patient Diary will be completed to assess overall satisfaction with analgesic technique |
| Presence of Block-related complications | Up to 48 hours post-operatively | Persistent paresthesia, post dural puncture headache |
Countries
Canada
Contacts
Primary ContactDidem Bozak
Outcome results
None listed