Patients Undergoing Major Laparoscopic Abdominal SurgeryPhase 4IMPACT-ScopeNCT06666985
Intrathecal Morphine for Postoperative Analgesia in Major Laparoscopic Abdominal Surgery, a IMPACT-Scope Trial
A Phase 4 study of Patients Undergoing Major Laparoscopic Abdominal Surgery, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients Undergoing Major Laparoscopic Abdominal Surgery
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 700 participants
- Where
- 1 siteChina
- Study dates
- 16 Dec 2024to Oct 2026
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jiangtao Zhou contact
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong
Xia Feng, 86-13688877856, fengxia@mail.sysu.edu.cn
About this study
Official title: Intrathecal Morphine for Postoperative Analgesia in Major Laparoscopic Abdominal Surgery (IMPACT-Scope): a Randomised, Sham-controlled, Blinded, Multicentre Clinical 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?
Read more
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
- Being tested
- ITM + Usual Care, Sham ITM + Usual Care
- Keywords
- laparoscopic surgery, intrathecal morphine, quality of recovery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ITM + Usual CareDrug
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 CareDrug
The sham ITM mimics the ITM procedure, but the dura is not breached.
| Study group | Role | What they receive |
|---|---|---|
| ITM + Usual Care | Experimental | Not described Receives: Drug: ITM + Usual Care |
| Sham ITM + Usual Care | Sham comparator | Not described Receives: Drug: Sham ITM + Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of recovery
Quality of recovery is measured using the 15-item Quality of Recovery Questionnaire (QoR-15)
Measured: Postoperative day 1
Secondary outcomes (16)
Quality of recovery
Quality of recovery is measured using the 15-item Quality of Recovery Questionnaire (QoR-15)
Measured: Postoperative day 2 , Postoperative day 3 (or at discharge, if earlier)
Quality of life
Quality of life is measured using the European Quality of life-5 Dimensions-5 Level (EQ-5D-5L)
Measured: 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
Pain scores is measured using a numeric rating scale (NRS 0-10)
Measured: Day of surgery
Worst pain score
Worst pain score is measured using a numeric rating scale (NRS 0-10)
Measured: 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)
Anaesthesia-related discomfort is measured using a bespoke questionnaire
Measured: Postoperative day 1, Postoperative day 2, Postoperative day 3 (or at discharge, if earlier)
Patient satisfaction
Patient satisfaction is measured using a bespoke questionnaire
Measured: 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
Measured: 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
Measured: 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 pulmonary complications is measured according to the Standardized Endpoints for Perioperative Medicine and the Core Outcome Measures in Perioperative and Anaesthetic Care (StEP-COMPAQ) definition
Measured: Postoperative day 1, Postoperative day 2 and Postoperative day 3 (or at discharge, if earlier)
Respiratory depression
Respiratory depression is defined as respiratory rate less than 8 breaths per minute AND need for medical intervention
Measured: Day of surgery, Postoperative day 1, Postoperative day 2, Postoperative day 3 (or at discharge, if earlier)
Total opioid consumption
Total opioid consumption is transformed into oral morphine equivalent daily dose
Measured: During operation and up to Postoperative day 30
Postoperative mobilisation
Postoperative mobilisation is ability to transfer from bed to chair, with or without assistance
Measured: Postoperative day 1,Postoperative day 2, Postoperative day 3 (or at discharge, if earlier)
Doses of antiemetics administered postoperatively (number of administration)
Measured: Day of Surgery, Postoperative day 1, Postoperative day 2, Postoperative day 3 (or at discharge, if earlier)
Length of Hospital Stay
Length of Hospital Stay (in days) is number of days from starting day of surgery to the day of discharge, calculated as discharge date - surgery date + 1 day
Measured: 1 Day after surgery
Days at Home and well After Surgery (DAH-30)
Measured: Postoperative day 30
Mortality
Measured: Postoperative day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2024
- Study start16 Dec 2024
- Primary completionSep 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patients Undergoing Major Laparoscopic Abdominal SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital, Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Feng Xia, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06666985
- Sponsor's protocol ID
- IIT-2023-989
- Acronym
- IMPACT-Scope
- Status last verified
- Nov 2025
- First submitted
- 28 Oct 2024
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 42476732