Intrathecal Morphine for Postoperative Analgesia in Major Laparoscopic Abdominal Surgery (IMPACT-Scope): a Randomised, Sham-controlled, Blinded, Multicentre Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 700
- 试验地点
- 1
- 主要终点
- Quality of recovery
研究概览
简要总结
The goal of this clinical trial is to learn the clinical and cost effectiveness of intrathecal morphine (ITM) in addition to usual care as a postoperative pain relief strategy following major laparoscopic abdominal surgery compared with current usual care. The main questions it aims to answer are:
An enhanced analgesic technique, consisting of ITM in addition to usual care , improves the postoperative quality of recovery at day 1 after surgery by at least 6 points on the 15-item quality of recovery questionnaire (QoR-15) compared to usual care alone, in patients undergoing major laparoscopic abdominal surgery?
Researchers will compare ITM + Usual care to Sham ITM + Usual Care (The sham ITM mimics the ITM procedure, but the dura is not breached) to see if ITM works to postoperative pain relief.
Participants will:
Receive ITM + Usual care or Sham ITM + Usual care on surgery day Have interview with outcome assessors and complete the CRFs on the day of surgery, postoperative day 1, day 2, day 3 and up to postoperative day 30
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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or over AND able to give informed consent (with interpreters provided where necessary)
- •Elective (i.e., planned) laparoscopic or robotic abdominal surgery within one or more of the following specialties:
- •Colorectal
- •Gynaecology
- •Hepato-biliary (including pancreatic surgery)
- •Upper gastrointestinal
- •Urology/Renal
- •Anticipated duration of surgery ≥ 2 hours (from knife-to-skin to end of wound closure)
- •Anticipated hospital stay ≥ 24 hours (from the end of surgery)
排除标准
- •* Allergy to study drugs
- •* Anatomical factors making intrathecal injection impossible
- •* Anticipated requirement for postoperative invasive ventilation
- •* American Society of Anesthesiologists (ASA) Score \1.3 and/or platelet count\<100×10\^9/L)
- •* Cognitive impairment leading to inability to complete the study processes and questionnaires
- •* Drugs affecting coagulation (except aspirin), which have not been suitably and timely paused preoperatively
- •* Infection near the planned site of intrathecal injection
- •* Ongoing sepsis
- •* Patients previously included in the trial and who need to return to theatre for a new abdominal surgery
- •* Pregnancy or breast feeding
研究组 & 干预措施
Sham ITM + Usual Care
干预措施: Sham ITM + Usual Care (Drug)
ITM + Usual Care
干预措施: ITM + Usual Care (Drug)
结局指标
主要结局
Quality of recovery
时间窗: Postoperative day 1
Quality of recovery is measured using the 15-item Quality of Recovery Questionnaire (QoR-15)
次要结局
- Quality of recovery(Postoperative day 2 , Postoperative day 3 (or at discharge, if earlier))
- Quality of life(Postoperative day 1, Postoperative day 2, Postoperative day 3 (or at discharge, if earlier) and Postoperative day 30)
- Pain scores in the post-anaesthesia recovery unit(Day of surgery)
- Worst pain score(Postoperative day 1, Postoperative day 2, and Postoperative day 3 (or at discharge, if earlier))
- Anaesthesia-related discomfort (nausea and/or vomiting, drowsiness, shivering, pruritus)(Postoperative day 1, Postoperative day 2, Postoperative day 3 (or at discharge, if earlier))
- Patient satisfaction(Postoperative day 1, Postoperative day 2, Postoperative day 3 (or at discharge, if earlier))
- Time in minutes to tracheal extubation from the end of anaesthesia(From end of anesthesia to tracheal extubation on day of surgery or from end of anesthesia to discharge day (for ICU patients) up to 48 hours)
- Number of pain management visits(Postoperative day 1, Postoperative day 2, Postoperative day 3(or at discharge, if earlier), day of discharge and Postoperative day 30)
- Postoperative pulmonary complications(Postoperative day 1, Postoperative day 2 and Postoperative day 3 (or at discharge, if earlier))
- Respiratory depression(Day of surgery, Postoperative day 1, Postoperative day 2, Postoperative day 3 (or at discharge, if earlier))
- Total opioid consumption(During operation and up to Postoperative day 30)
- Postoperative mobilisation(Postoperative day 1,Postoperative day 2, Postoperative day 3 (or at discharge, if earlier))
- Doses of antiemetics administered postoperatively (number of administration)(Day of Surgery, Postoperative day 1, Postoperative day 2, Postoperative day 3 (or at discharge, if earlier))
- Length of Hospital Stay(1 Day after surgery)
- Days at Home and well After Surgery (DAH-30)(Postoperative day 30)
- Mortality(Postoperative day 30)
研究者
Feng Xia
Professor
First Affiliated Hospital, Sun Yat-Sen University