跳至主要内容
临床试验/NCT06556121
NCT06556121招募中不适用

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

Women's College Hospital2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年8月7日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
2
主要终点
Cumulative opioid (analgesic) consumption

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Investigator)

盲法说明

Patient, anesthesiologist in the operating room

入排标准

年龄范围
15 Years 至 70 Years(Child, Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • ASA I-III patients
  • Ages 15-70 years

排除标准

  • 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.

结局指标

主要结局

Cumulative opioid (analgesic) consumption

时间窗: 48 hours

Consumption intra-operatively, total in-hospital postoperative consumption measured oral morphine equivalents (MEQ)

次要结局

  • Time to first analgesic request(24 hours)
  • Pain Assessment (VAS)(Up to 48 hours post-operatively)
  • Incidence of opioid-related side effects(Up to 48 hours post-operatively)
  • Quality of Life scores(48 hours post-operatively)
  • Patient Satisfaction with Analgesic Technique and Pain management(24 hours post-operatively)
  • Presence of Block-related complications(Up to 48 hours post-operatively)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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