Intrathecal Morphine for Postoperative Analgesia in Major Laparoscopic Abdominal Surgery, a IMPACT-Scope Trial

Официальное название

Intrathecal Morphine for Postoperative Analgesia in Major Laparoscopic Abdominal Surgery (IMPACT-Scope): a Randomised, Sham-controlled, Blinded, Multicentre Clinical Trial

Обзор

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

Вмешательства

• Препарат ITM + Usual Care
  The participants allocated to this group will receive ITM (Intrathecal Morphine) in addition to usual care with opioid-based PCA(Patient-Controlled Analgesia). ITM consists of an intrathecal injection of 300 micrograms (0.3mg) of preservative-free morphine.Usual care involves postoperative analgesia with opioid-based PCA without postoperative continuous infusion of opioids. No other drugs other than opioids are allowed in the PCA.
• Препарат Sham ITM + Usual Care
  The sham ITM mimics the ITM procedure, but the dura is not breached.

Первичные конечные точки

• Quality of recovery [Срок оценки: Postoperative day 1]

Вторичные конечные точки (12)

• Quality of recovery [Срок оценки: Postoperative day 2 , Postoperative day 3 (or at discharge, if earlier)]
• Quality of life [Срок оценки: 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 [Срок оценки: Day of surgery]
• Worst pain score [Срок оценки: 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) [Срок оценки: Postoperative day 1, Postoperative day 2, Postoperative day 3 (or at discharge, if earlier)]
• Patient satisfaction [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Postoperative day 1, Postoperative day 2, Postoperative day 3(or at discharge, if earlier), day of discharge and Postoperative day 30]
• Postoperative pulmonary complications [Срок оценки: Postoperative day 1, Postoperative day 2 and Postoperative day 3 (or at discharge, if earlier)]
• Respiratory depression [Срок оценки: Day of surgery, Postoperative day 1, Postoperative day 2, Postoperative day 3 (or at discharge, if earlier)]
• Total opioid consumption [Срок оценки: During operation and up to Postoperative day 30]
• Postoperative mobilisation [Срок оценки: Postoperative day 1,Postoperative day 2, Postoperative day 3 (or at discharge, if earlier)]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• Allergy to study drugs
• Anatomical factors making intrathecal injection impossible
• Anticipated requirement for postoperative invasive ventilation
• American Society of Anesthesiologists (ASA) Score <IV
• Coagulopathies (i.e. INR>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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The First Affiliated Hospital of Sun Yat-sen University — Гуанчжоу

Публикации

• Ma W, Morgese C, Xiong W, Liu Y, Wu J, He Q, Wei M, Zhou J, Liang R, Ives N, Xu F, Jackson L, Soden M, Cheng KK, Gao Smith F, Feng X. Intrathecal morphine for postoperative analgesia in major laparoscopic abdominal surgery (IMPACT-Scope): a protocol for a randomised controlled trial. BMJ Open. 2026 Jul 20;16(7):e120306. doi: 10.1136/bmjopen-2026-120306. PMID 42476732

Идентификаторы

NCT: NCT06666985 · IIT-2023-989

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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