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临床试验/NCT07836010
NCT07836010尚未招募4 期

The Impact of Adding Suzetrigine to Multimodal Analgesia for Minimally Invasive Hysterectomy

Duke University0 个研究点目标入组 123 人开始时间: 2026年11月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
123
主要终点
Postoperative opioid use after Post-Anesthesia Care Unit (PACU) discharge following surgery

研究概览

简要总结

This study will assess the analgesic efficacy of suzetrigine as part of a multimodal analgesic regimen in women undergoing laparoscopic or robotic hysterectomy. Outcomes will be compared with matched historical controls receiving the current ERAS regimen without suzetrigine.

详细描述

This will be a matched cohort study with a prospective and a retrospective component. Women undergoing laparoscopic/robotic hysterectomy with our ERAS protocol will be approached to participate in the prospective open label component of the study. In the preoperative holding area, patients will be asked about their preoperative anxiety and expectations for postoperative pain. Preoperative patient-reported anxiety will be assessed by asking the question: "On a scale from 1 to 100, how anxious are you regarding your upcoming surgery?" Postoperative anticipated opioid need will be measured by asking, "Do you anticipate requiring below average, average, or above average amount of pain medication following surgery?". Preoperatively, patients will receive the first dose of suzetrigine (100 mg) approximately 1 hour prior to surgery. Midazolam can be used for anxiolysis as needed. Intraoperatively, patients will receive the usual intraoperative ERAS analgesic regimen used at Duke university typically incorporating intraoperative opioids (typically fentanyl and hydromorphone), intraoperative IV acetaminophen 1000 mg and IV ketorolac 15 mg. In PACU, IV fentanyl will be allowed for analgesia as per standard practice. Postoperative multimodal analgesia will incorporate scheduled acetaminophen, ibuprofen and suzetrigine (50 mg q12h, oral) around the clock. Oral oxycodone will be used for rescue as required. Patients will be encouraged to wait at least 60 minutes after taking a dose of acetaminophen and ibuprofen before use of the opioid rescue. Patients will be contacted daily to collect data about verbal rating pain scores (0= no pain, 10= worst possible pain), opioid consumption and any adverse events. In addition, on day 7, additional information will be collected about patient global assessment of pain control (poor, fair, good, very good, excellent).

Cases will be matched in a 1:2 ratio by age, race, insurance status, duration of surgery, preoperative anxiety and anticipated need for analgesia with historical controls who received postoperative analgesia using our current multimodal analgesic regimen. The historical controls will be identified from a database of patients who underwent minimally invasive hysterectomy with documented end points that the investigators are using in this study. Those patients also have information documented that was collected prospectively about anxiety and anticipated analgesic needs, factors that have been shown to be associated with postoperative opioid consumption.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Patients ≥18 years presenting for a laparoscopic/robotic hysterectomy.
  • •ASA Classification I-III.

排除标准

  • •Chronic pain or chronic opioid therapy.
  • •Allergy or contraindication to any component of the multimodal analgesic regimen.
  • •Need to convert to an open procedure.
  • •Subjects with severe hepatic or renal impairment and those receiving CYP3A inhibitors.
  • •Inability to communicate pain scores or need for analgesics.
  • •Suspected or known addiction to or abuse of illicit drugs, prescription medicine(s) or alcohol within the past 2 years.
  • •Psychiatric disorders that, in the opinion of the investigator, may interfere with study assessments or compliance.
  • •Current or historical evidence of any clinically significant disease or condition that, in the opinion of the investigator, may increase the risk of surgery or complicate the subject's postoperative course.
  • •Pregnancy.

研究组 & 干预措施

Control Group

No Intervention

Standard Multimodal analgesia (historical cohort)

Suzetrigine Group

Experimental

Suzetrigine added to standard multimodal analgesia

干预措施: Suzetrigine (Drug)

结局指标

主要结局

Postoperative opioid use after Post-Anesthesia Care Unit (PACU) discharge following surgery

时间窗: Up to 7 days after PACU discharge following surgery

Number of participants needing any opioids

次要结局

  • Total post-surgical opioid consumption after PACU discharge following surgery(Up to 7 days after PACU discharge following surgery)
  • Average pain score in the first week following PACU discharge after surgery(Up to 7 days after PACU discharge following surgery)
  • Pain score on day 7(Day 7 after surgery)
  • Duration of PACU stay(PACU stay, up to approximately 3 hours)
  • Need for opioids in PACU(PACU stay, up to approximately 3 hours)
  • Opioid consumption in PACU(PACU stay, up to approximately 3 hours)

研究者

发起方
Duke University
申办方类型
Other
责任方
Sponsor

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