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Trial registered on ANZCTR


Registration number
ACTRN12619000355178
Ethics application status
Approved
Date submitted
22/02/2019
Date registered
6/03/2019
Date last updated
20/11/2019
Date data sharing statement initially provided
6/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Analgesia for major laparoscopic abdominal surgery using Intrathecal Morphine. A Feasibility Study.
Scientific title
Analgesia for major laparoscopic abdominal surgery using Intrathecal Morphine. A Feasibility Study.
Secondary ID [1] 297085 0
nil known
Universal Trial Number (UTN)
Trial acronym
AIM (Abdominal surgery Intrathecal Morphine)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post operative pain 311255 0
Quality of recovery 311727 0
Condition category
Condition code
Anaesthesiology 309879 309879 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A single dose of intrathecal morphine will be administered immediately pre operatively in inpatients undergoing elective, major laparoscopic abdominal surgery. Major surgery is that where the predicted surgical time is greater than 2 hours. Morphine dose 0.15 mg - 0.4 mg, chosen at the discretion of the treating anaesthetist, based on the type of surgery, and patient factors in this pragmatically designed trial. All other components of anaesthesia and intra operative analgesia will be at the discretion of the treating anaesthetist. Post operatively, patient controlled analgesia (PCA) with intravenous fentanyl (10-20mcg, 5-10min lock out) will be prescribed.
Intervention code [1] 313461 0
Treatment: Drugs
Comparator / control treatment
Control group will receive a single subcutaneous injection of 0.9% saline in the lumbar region immediately pre operatively to achieve single-blinding. They will receive intravenous opioid, the dose and type at the discretion of the treating anaesthetist whilst under general anaesthesia. Post operatively, patient controlled analgesia (PCA) with intravenous fentanyl (10-20mcg, 5-10min lock out) will be prescribed.
Control group
Active

Outcomes
Primary outcome [1] 318824 0
To measure the ability to recruit eligible patients into the study. Criteria: The study protocol will be assessed as feasible if a recruitment rate of at least 50% is achieved.
Timepoint [1] 318824 0
12 months after recruitment commences
Primary outcome [2] 318825 0
To measure the ability to successfully deliver each of the analgesic techniques according to the research protocol. Criteria: The study protocol will be assessed as feasible if a successful delivery rate, without need for cross-over, of at least 80% is achieved. Delivery rate data will be collected from hospital records.
Timepoint [2] 318825 0
1 day from recruitment of patient
Secondary outcome [1] 366161 0
Patient recovery as assessed by QoR-15
Timepoint [1] 366161 0
Once between post operative day 1 to 3 and on day 30
Secondary outcome [2] 367365 0
Total opioid consumption post operatively as assessed by analysis of PCA machine analytics and investigation of medical record
Timepoint [2] 367365 0
Measured at patient discharge from hospital
Secondary outcome [3] 367366 0
Length of hospital stay as assessed by time from operation to discharge home. Data will be obtained from hospital records.
Timepoint [3] 367366 0
Discharge home from hospital
Secondary outcome [4] 367367 0
Rest pain as assessed by numerical rating score
Timepoint [4] 367367 0
In post anaesthetic care unit (PACU), and once per day whilst an inpatient through to day 3
Secondary outcome [5] 367368 0
Sedation as assessed by Ramsay sedation score
Timepoint [5] 367368 0
In PACU, on post operative day 1, 2 and 3 unless discharged earlier
Secondary outcome [6] 367369 0
Respiratory depression as assessed by respiratory rate less than 8 breaths per minute. Outcome data will be obtained from medical record observation chart.
Timepoint [6] 367369 0
Any timepoint during admission post operation
Secondary outcome [7] 367831 0
Dynamic pain as assessed by numerical rating score
Timepoint [7] 367831 0
In post anaesthetic care unit (PACU), and once per day whilst an inpatient through to day 3

Eligibility
Key inclusion criteria
• > 18 years old
• Patients scheduled for elective major laparoscopic or lap-assisted abdominal surgery, and
• Planned operative time of over 2 hours
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- < 18 years old
- Patient decline or inability to consent
- Contraindication to morphine
- Contraindication to a neuraxial injection including local site concerns, coagulopathy (including anticoagulant medication within safe timeframe), raised intracranial pressure, and 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
- Women lactating or pregnant

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 computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
A formal sample size calculation has not been done given this is a feasibility study and the associated objectives. We want to collect sufficient data over a 1-year period in order to inform a future large trial. We anticipate that 60-100 patients will be enrolled. Hence, there will be 30-50 patients in each arm.

Data will be expressed as percentages with numbers, means with standard deviations or medians with interquartile ranges. Group comparisons will be described by point estimates with their 95% confidence intervals.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 12990 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [2] 12991 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 25469 0
2065 - St Leonards
Recruitment postcode(s) [2] 25470 0
3000 - Melbourne

Funding & Sponsors
Funding source category [1] 301652 0
Charities/Societies/Foundations
Name [1] 301652 0
Australia and New Zealand College of Anaesthetists
Address [1] 301652 0
ANZCA House
630 St Kilda Rd
Melbourne , 3000
Victoria
Australia
Country [1] 301652 0
Australia
Primary sponsor type
Individual
Name
Dr Katrina Pirie
Address
Royal North Shore Hospital
Reserve Rd
St Leonard's Place
NSW, 2065
Country
Australia
Secondary sponsor category [1] 301364 0
Hospital
Name [1] 301364 0
Peter MacCallum Cancer Centre
Address [1] 301364 0
305 Grattan St
Melbourne, 3000
Victoria
Australia
Country [1] 301364 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302373 0
Northern Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 302373 0
Kolling Institute of Medical Research
Royal North Shore Hospital
Pacific Hwy,
St Leonards
NSW 2065
Ethics committee country [1] 302373 0
Australia
Date submitted for ethics approval [1] 302373 0
22/02/2019
Approval date [1] 302373 0
17/04/2019
Ethics approval number [1] 302373 0

Summary
Brief summary
Major abdominal surgery is a common procedure associated with significant postoperative pain and morbidity. The importance of high quality perioperative care is clear, and effective postoperative analgesia is fundamental to recovery. Intrathecal Morphine (ITM) is an increasingly popular analgesic option in major abdominal surgery and in laparascopic colorectal surgery, has been reported to reduce pain scores and total opioid consumption. In the context of a worldwide opioid epidemic, strategies to minimise opioid use whilst optimising patient comfort and functional recovery are priorities in the perioperative setting.

We believe ITM will be superior to intravenous analgesia alone in terms of quality of recovery, cost saving and opioid-sparing in the context of similar or lower side effects. The results of this preliminary feasibility study will be used to design a large-scale phase III, multicentre trial with the objective of obtaining outcomes that will accurately inform clinical practice.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 90002 0
Dr Katrina Pirie
Address 90002 0
Department Anaesthesia
Royal North Shore Hospital
Reserve Rd
St Leonards,
NSW 2065
Country 90002 0
Australia
Phone 90002 0
+61 02 94632488
Fax 90002 0
Email 90002 0
katrina.pirie@health.nsw.gov.au
Contact person for public queries
Name 90003 0
Dr Katrina Pirie
Address 90003 0
Department Anaesthesia
Royal North Shore Hospital
Reserve Rd
St Leonards,
NSW 2065
Country 90003 0
Australia
Phone 90003 0
+61 02 94632488
Fax 90003 0
Email 90003 0
katrina.pirie@health.nsw.gov.au
Contact person for scientific queries
Name 90004 0
Dr Katrina Pirie
Address 90004 0
Department Anaesthesia
Royal North Shore Hospital
Reserve Rd
St Leonards,
NSW 2065
Country 90004 0
Australia
Phone 90004 0
+61 02 94632488
Fax 90004 0
Email 90004 0
katrina.pirie@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
No Results