Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06556121
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-13
Brief Title:
Saddle Block with IT Morphine for Penile Inversion Vaginoplasty
Sponsor:
None
Organization:
None
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None