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

ConditionPatients Undergoing Major Laparoscopic Abdominal Surgery
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • ITM + Usual Care

    Drug

    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.

  • Sham ITM + Usual Care

    Drug

    The sham ITM mimics the ITM procedure, but the dura is not breached.

Treatment groups

700 Participants
are divided into 2 treatment groups
Group A: ITM + Usual CareExperimental treatment 1 intervention
Group B: Sham ITM + Usual CareSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Quality of recovery

Quality of recovery is measured using the 15-item Quality of Recovery Questionnaire (QoR-15)

Time frame
Postoperative day 1

Secondary outcomes

1

Quality of recovery

Quality of recovery is measured using the 15-item Quality of Recovery Questionnaire (QoR-15)

Time frame
Postoperative day 2 , Postoperative day 3 (or at discharge, if earlier)
2

Quality of life

Quality of life is measured using the European Quality of life-5 Dimensions-5 Level (EQ-5D-5L)

Time frame
Postoperative day 1, Postoperative day 2, Postoperative day 3 (or at discharge, if earlier) and Postoperative day 30
3

Pain scores in the post-anaesthesia recovery unit

Pain scores is measured using a numeric rating scale (NRS 0-10)

Time frame
Day of surgery
4

Worst pain score

Worst pain score is measured using a numeric rating scale (NRS 0-10)

Time frame
Postoperative day 1, Postoperative day 2, and Postoperative day 3 (or at discharge, if earlier)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

First Affiliated Hospital, Sun Yat-Sen University

Lead sponsor

Source ClinicalTrials.gov
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