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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorFirst Affiliated Hospital, Sun Yat-Sen University

About this trial

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

Eligibility criteria

Qualifiers

Age 18 years or over AND able to give informed consent (with interpreters provided where necessary)

Colorectal

Gynaecology

Hepato-biliary (including pancreatic surgery)

Disqualifiers

Allergy to study drugs

Anatomical factors making intrathecal injection impossible

Anticipated requirement for postoperative invasive ventilation

American Society of Anesthesiologists (ASA) Score <IV

Trial design

Treatments tested in this trial

  • ITM + Usual Care
  • Sham ITM + Usual Care

Treatment groups

700 Participants
are divided into 2 treatment groups