Suzetrigine for Opioid-Sparing Postoperative Analgesia Following Transvaginal Pelvic Reconstructive Surgery
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 120
- 试验地点
- 1
研究概览
简要总结
Suzetrigine is a selective NaV1.8 inhibitor that provides peripheral analgesia without opioid-related CNS effects. This single-center stepped-wedge randomized clinical trial evaluates whether a suzetrigine-based postoperative analgesic regimen provides non-inferior pain control compared with standard opioid-inclusive care following transvaginal pelvic reconstructive surgery. The study will enroll 120 participants and assess pain, opioid consumption, adverse events, and functional recovery.
详细描述
Suzetrigine has demonstrated analgesic efficacy comparable to hydrocodone/acetaminophen in Phase III trials and is FDA-approved for acute pain. This trial represents the first evaluation of a NaV1.8 inhibitor in pelvic reconstructive surgery. Participants will receive either suzetrigine or standard opioid-inclusive postoperative care according to a stepped-wedge randomization schedule. Pain scores, medication use, and adverse events will be collected at 48 hours, 1 week, and 6 weeks postoperatively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Single (Care Provider)
盲法说明
Treating surgeons will remain blinded to treatment allocation. Participants and study staff will not be blinded due to differences in medication appearance and administration.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years.
- •Undergoing elective transvaginal pelvic reconstructive surgery at UCLA with planned same-day discharge or 23-hour observation.
- •Able to provide written informed consent.
排除标准
- •Chronic opioid use.
- •Liver failure.
- •End-stage renal disease (ESRD).
- •Chronic pain syndromes, including:
- •Fibromyalgia Interstitial cystitis Chronic pelvic pain
- •Contraindication to acetaminophen or ibuprofen.
- •Use of strong CYP3A4 inhibitors within 7 days prior to surgery or anticipated need during the treatment period.
研究组 & 干预措施
Suzetrigine-Based Regimen
Participants receive suzetrigine as part of a multimodal postoperative analgesic regimen. Suzetrigine is administered as a loading dose on the morning of surgery followed by twice-daily dosing for 7 days, in combination with scheduled acetaminophen and ibuprofen.
干预措施: Suzetrigine (Drug)
Standard Opioid-Inclusive Analgesic Regimen
Participants receive standard postoperative pain management consisting of scheduled acetaminophen and ibuprofen, with opioid analgesics available as needed per routine clinical care.
干预措施: Opioid Analgesics (Tramadol or Oxycodone) (Drug)
Suzetrigine-Based Regimen
Participants receive suzetrigine as part of a multimodal postoperative analgesic regimen. Suzetrigine is administered as a loading dose on the morning of surgery followed by twice-daily dosing for 7 days, in combination with scheduled acetaminophen and ibuprofen.
干预措施: Scheduled Acetaminophen and Ibuprofen (Drug)
Standard Opioid-Inclusive Analgesic Regimen
Participants receive standard postoperative pain management consisting of scheduled acetaminophen and ibuprofen, with opioid analgesics available as needed per routine clinical care.
干预措施: Scheduled Acetaminophen and Ibuprofen (Drug)
研究者
Anne Lenore Ackerman
Associate Professor of Urology at UCLA, Director of Research, Division of Female Pelvic Medicine and Reconstructive Surgery at UCLA
University of California, Los Angeles