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Trial registered on ANZCTR


Registration number
ACTRN12623001347651p
Ethics application status
Not yet submitted
Date submitted
29/11/2023
Date registered
20/12/2023
Date last updated
20/12/2023
Date data sharing statement initially provided
20/12/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Analgesia for patients undergoing minimally invasive major abdominal surgery using Intrathecal Morphine with local anaesthetic. The AIM Study.
Scientific title
Determine whether analgesia for patients undergoing minimally invasive major abdominal surgery using Intrathecal Morphine with local anaesthetic affects quality of recovery. The AIM Study.
Secondary ID [1] 310966 0
None
Universal Trial Number (UTN)
Trial acronym
AIM
Linked study record
This is the follow-up study to the feasibility study (ACTRN12622000625774)

Health condition
Health condition(s) or problem(s) studied:
Anaesthesiology 332051 0
Quality of recovery 332322 0
Postoperative recovery 332323 0
Condition category
Condition code
Anaesthesiology 328775 328775 0 0
Pain management
Anaesthesiology 329033 329033 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A single dose of intrathecal morphine (ITM) (200mcg, or 300mcg after safety review of the first 100 patients recruited) with local anaesthetic will be administered following full sterile precautions using a spinal needle immediately preoperatively by the treating anaesthesiologist to patients undergoing minimally invasive (laparoscopic, lap-assisted or robotic) major abdominal surgery. The procedure will be recorded in the patient's medical record and in the case report forms. Major surgery is that where the predicted surgical time is greater than 2 hours. Multimodal analgesia including paracetamol, parecoxib and local anaesthetic (LA) (regional technique, infusion or infiltration) will be encouraged. These will be administered at the discretion of the treating anaesthesiologist intraoperatively. 50mcg Fentanyl boluses will be administered when heart rate or blood pressure are greater than 20% of baseline. Postoperative fentanyl Patient Controlled Analgesia (PCA) (10 mcg bolus, 10 min lockout) for 24 hours following ITM injection.
Intervention code [1] 327397 0
Treatment: Drugs
Comparator / control treatment
The control group will receive multimodal analgesia including intravenous paracetamol, parecoxib and local anaesthetic (LA) (regional technique, infusion or infiltration) will be encouraged. These will be administered at the discretion of the treating anaesthesiologist intraoperatively and recorded in the medical record and on the case report form. 50mcg Fentanyl boluses will be administered when heart rate or blood pressure are greater than 20% of baseline intraoperatively. Postoperative fentanyl PCA (10 mcg bolus, 10 min lockout) for 24 hours.
Control group
Active

Outcomes
Primary outcome [1] 336584 0
Quality of recovery
Timepoint [1] 336584 0
Post operative day 1
Secondary outcome [1] 428873 0
Opioid consumption,
Timepoint [1] 428873 0
Measured intra-operatively, in the recovery unit, at 24 hours, 48 hours and 72 hours post-operatively.
Secondary outcome [2] 428874 0
Rest pain
Timepoint [2] 428874 0
in the recovery unit, and daily whilst an inpatient through to post-operative day 3, unless discharged earlier. Worst score at measure time-point will be recorded.
Secondary outcome [3] 428875 0
Return bowel function
Timepoint [3] 428875 0
Time from end of surgery to return of bowel motions
Secondary outcome [4] 428876 0
Nausea
Timepoint [4] 428876 0
Daily assessment up until postoperative day 3
Secondary outcome [5] 428877 0
Vomiting
Timepoint [5] 428877 0
any point during admission until post operative day 3
Secondary outcome [6] 428878 0
Pruritus
Timepoint [6] 428878 0
Once daily in addition to PACU, until post operative day 3
Secondary outcome [7] 428879 0
Hypotension
Timepoint [7] 428879 0
Postoperatively until day 3
Secondary outcome [8] 428880 0
Duration urinary catheter
Timepoint [8] 428880 0
Duration from end of surgery until removal up until postoperative day 3
Secondary outcome [9] 428881 0
Time to mobilise
Timepoint [9] 428881 0
From end of surgery until achieved up until post operative day 3
Secondary outcome [10] 428882 0
Time to commence oral diet
Timepoint [10] 428882 0
End of surgery until time achieved
Secondary outcome [11] 428883 0
Sedation
Timepoint [11] 428883 0
Measure in PACU, and on each postoperative day until postoperative day 3
Secondary outcome [12] 428884 0
Respiratory depression
Timepoint [12] 428884 0
Any time point during hospital admission post-operatively.
Secondary outcome [13] 428885 0
Length of hospital stay
Timepoint [13] 428885 0
Time point – discharge from hospital.
Secondary outcome [14] 428886 0
persistent opioid use
Timepoint [14] 428886 0
postoperative day 90
Secondary outcome [15] 428887 0
Days at home and alive as a composite outcome
Timepoint [15] 428887 0
Day 30 postoperatively
Secondary outcome [16] 429426 0
degree of intraoperative hypotension
Timepoint [16] 429426 0
Intraoperative period
Secondary outcome [17] 429803 0
Dynamic pain score
Timepoint [17] 429803 0
in the recovery unit, and daily whilst an inpatient through to post-operative day 3, unless discharged earlier. Worst score at measure time-point will be recorded.
Secondary outcome [18] 429804 0
Mortality
Timepoint [18] 429804 0
30 days postoperatively

Eligibility
Key inclusion criteria
• Greater than or equal to 18 years old
• Patients scheduled for elective major laparoscopic, lap-assisted or robotic abdominal surgery, and
• Major surgery is that with a planned operative time of over 2 hours
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• < 18 years old
• Patient declines enrolment or inability to consent
• Contraindication to intrathecal morphine
• Contraindication to a neuraxial injection, including; injection site concerns, coagulopathy (including administration of anticoagulant), or untreated sepsis
• Cognitive impairment or language proficiency leading to inability to complete QoR-15 questionnaire or understand the pain scores
• Chronic pain, including baseline opioid use prior to hospital admission

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by REDCap
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis
In a previous study the Quality of Recovery-15 response within each subject group was normally distributed, with a standard deviation of 15. If the minimally clinically important difference of QoR-15 is 6 (24) we will need to study 132 experimental subjects and 132 control subjects to be able to reject the null hypothesis that the population means of the experimental and control groups are equal, with probability (power) 0.9. The Type I error probability associated with this test of this null hypothesis is 0.05. Therefore, we plan to recruit 280 patients to retain adequate power, accounting for up to 5% loss to follow up amongst recruited patients.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
280
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 25840 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [2] 25841 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [3] 25842 0
The Alfred - Melbourne
Recruitment postcode(s) [1] 41668 0
3000 - Melbourne
Recruitment postcode(s) [2] 41669 0
2065 - St Leonards

Funding & Sponsors
Funding source category [1] 315223 0
Charities/Societies/Foundations
Name [1] 315223 0
Australia and New Zealand College of Anaesthetists
Country [1] 315223 0
Australia
Primary sponsor type
Hospital
Name
Alfred Health
Address
55 Commercial Road, Melbourne 3004
Country
Australia
Secondary sponsor category [1] 317375 0
None
Name [1] 317375 0
Address [1] 317375 0
Country [1] 317375 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 314148 0
Alfred Health - Alfred Hospital Human Research Ethics Committee
Ethics committee address [1] 314148 0
55 Commercial Road, Melbourne, Victoria 3004
Ethics committee country [1] 314148 0
Australia
Date submitted for ethics approval [1] 314148 0
22/01/2024
Approval date [1] 314148 0
Ethics approval number [1] 314148 0

Summary
Brief summary
This multicentre, randomised trial aims to determine whether a single preoperative dose of intrathecal morphine with local anaesthetic in patients undergoing elective minimally invasive major abdominal surgery improves quality of recovery as measured by the QoR-15 score on post operative day 1 where a difference of 6 is deemed clinically important. Patients will be randomised into the intervention group (preoperative injection of intrathecal morphine 200 mcg with local anaesthetic + multimodal analgesia) or the control group (multimodal analgesia). A dose increase of intrathecal morphine to 300mcg will occur after recruiting the first 100 patients and following review of safety data. Secondary outcomes of interest include cumulative opioid consumption over the first 3 postoperative days, dynamic and rest pain scores, return of bowel function, opioid related adverse events, hospital length of stay, persistent opioid use and pain at day 90.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 130586 0
Dr Katrina Pirie
Address 130586 0
Alfred Health, 55 Commercial Road, Melbourne 3004
Country 130586 0
Australia
Phone 130586 0
+61 3 90763707
Fax 130586 0
Email 130586 0
[email protected]
Contact person for public queries
Name 130587 0
Katrina Pirie
Address 130587 0
Alfrd Health, 55 Commercial Road, Melbourne 3004
Country 130587 0
Australia
Phone 130587 0
+61 3 9076 2000
Fax 130587 0
Email 130587 0
[email protected]
Contact person for scientific queries
Name 130588 0
Katrina Pirie
Address 130588 0
Alfred Health, 55 Commercial Road, Melbourne 3004
Country 130588 0
Australia
Phone 130588 0
+61 3 9076 2000
Fax 130588 0
Email 130588 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
de-identified, individual participant data underlying published results
When will data be available (start and end dates)?
6 months following publication of the results from our study in a peer reviewed journal
Available to whom?
Upon request by researchers who provide a methodologically sound proposal
Available for what types of analyses?
For MA
How or where can data be obtained?
Contacting the principal investigator by email address ([email protected])


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.