Effect of Oliceridine-based Intravenous Patient-Controlled Analgesia on Chronic Postsurgical Pain After Video-Assisted Thoracoscopic Lung Resection: A Multicenter Randomized Double-Blind Controlled Trial Protocol
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 320
- 试验地点
- 8
- 主要终点
- Incidence of chronic pain after surgery
研究概览
简要总结
The primary objective is to evaluate the impact of oliceridine versus sufentanil for perioperative analgesia on the incidence of chronic postsurgical pain (CPSP) with functional impact in patients undergoing video-assisted thoracoscopic surgery.
详细描述
The primary objective is to evaluate the impact of oliceridine versus sufentanil administered via patient controlled intravenous analgesia (PCIA) for perioperative analgesia on the incidence of chronic postsurgical pain (CPSP) with functional impact in patients undergoing video-assisted thoracoscopic surgery. This is a multicentre, randomised, double-blind, controlled trial enrolling 320 patients across seven Chinese tertiary centres.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-75 years
- •ASA physical status I-III
- •BMI 18-35 kg/m²
- •Scheduled for unilateral video-assisted thoracoscopic surgery (VATS) lung resection, including wedge resection, segmentectomy, lobectomy, or radical resection for lung cancerresection for lung cancer
- •Preoperative Numeric Rating Scale (NRS) pain score of 0
- •Ability to understand the study objectives and procedures, with voluntary informed consent obtained
- •Expected postoperative recovery in the general ward setting
排除标准
- •History of chronic pain or long-term analgesic use prior to surgery
- •Previous ipsilateral thoracic surgery
- •Prior neoadjuvant radiotherapy or chemotherapy
- •Severe cardiovascular or cerebrovascular disease, or hepatic/renal dysfunction (ALT/AST > 3 × upper limit of normal; eGFR < 60 mL/min/1.73 m²)
- •Severe or unstable psychiatric disorders requiring psychoactive medication (e.g., schizophrenia, bipolar disorder), or cognitive impairment precluding reliable self-report
- •Other concurrent active malignancy or active infection
- •Known hypersensitivity to study medications (opioids, adjuvant analgesics, anesthetics, or antiemetics)
- •Pregnancy, lactation, or planned pregnancy during the study period
- •Participation in another interventional clinical trial within 3 months before enrolment
- •Any condition deemed unsuitable for study participation by the investigator
研究组 & 干预措施
Oliceridine group
Administer a loading dose of 0.02 mg/kg intravenously 20-30 minutes before the end of surgery. Postoperative PCA pump configuration: 0.4 mg/kg oliceridine diluted with normal saline to a total volume of 100 mL, with a background infusion rate of 2 mL/h, PCA bolus dose of 0.5 mL per injection, lockout interval of 15 minutes, and treatment duration of 48 hours. The cumulative oliceridine dose should not exceed 27 mg per 24 hours, in accordance with the FDA prescribing information.
干预措施: Oliceridine (Drug)
Sufentanil group
Administer a loading dose of 0.1 μg/kg intravenously 20-30 minutes before the end of surgery. Postoperative PCA pump configuration: 2 μg/kg sufentanil diluted with normal saline to a total volume of 100 mL, with a background infusion rate of 2 mL/h, PCA bolus dose of 0.5 mL per injection, lockout interval of 15 minutes, and treatment duration of 48 hours.
干预措施: Sufentanil (Drug)
结局指标
主要结局
Incidence of chronic pain after surgery
时间窗: from day 1 to day 90 after surgery
Chronic pain intensity was assessed by a numeric rating scale (NRS) using a telephone questionnaire
Incidence of chronic postsurgical pain with functional impact at 3 months after surgery
时间窗: At 3 months after surgery (assessment window: postoperative day 90 +/- 14 days)
CPSP is a composite binary endpoint, positive only when all three criteria are met: (1) pain related to thoracoscopic surgery, confirmed by the scripted question "Do you currently have persisting pain related to your thoracoscopic surgery?", localized to the surgical site or a referred area, present for at least 3 months, and not attributable to other causes (local infection, tumour recurrence, or a new surgical or medical condition); (2) average numeric rating scale (NRS) pain score \>= 1 (0-10) at the surgical site during the week preceding the assessment; and (3) pain-related functional interference, defined as a pain interference score \>= 1 on the Brief Pain Inventory-Short Form (validated Chinese version), calculated as the mean of 7 interference items (each 0-10; prorated mean if at least 4 of 7 items are completed), with a 1-week recall period.
次要结局
- postoperative acute pain NRS scoring(24h and 48h after surgery)
- Incidence of adverse events(48 hours after surgery)
- Chronic pain NRS score 3 months after surgery(3 months postoperatively)
- Neuropathic pain (DN4 score ≥ 4)(1 day preoperatively；3 months postoperatively)
- Sleep quality assessment(1 day preoperatively；3 months postoperatively)
- Psychological status assessment(1 day preoperatively； 3 months postoperatively)
- Evaluate pain catastrophizing levels in surgical patients(1 day preoperatively；3 months postoperatively)
- Quality of Life Assessments(1 day preoperatively；3 months postoperatively)
- Use and frequency of rescue analgesic administration(1 day preoperatively；3 months postoperatively)
- Quality of Recovery-15 (QoR-15) score(24h and 48h after surgery)
- Cumulative PCA opioid consumption and bolus deliveries(0-48 hours postoperatively)
- Incidence of opioid-related adverse events(0-48 h postoperatively)
- Use and frequency of rescue analgesic administration(0-48h postoperatively, 1 month postoperatively, 3 months postoperatively)
- Brief Pain Inventory-Short Form (BPI-SF) pain severity and pain interference scores(1 month postoperatively, 3 months postoperatively)
- Incidence of neuropathic pain component (DN4i ≥ 4)(1 month postoperatively, 3 months postoperatively)
- Postoperative acute pain NRS score(24h and 48h after surgery)
- Sleep quality assessment(1 day preoperatively(baseline), 1 month postoperatively, 3 months postoperatively)
- Psychological status assessment(1 day preoperatively(baseline), 1 month postoperatively, 3 months postoperatively)
- Pain catastrophizing level(1 day preoperatively(baseline), 1 month postoperatively, 3 months postoperatively)
- Quality of life assessment(1 day preoperatively(baseline), 3 months postoperatively)
研究者
Yang Jiao
Associate Chief Physician
Tianjin Medical University General Hospital