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Trial registered on ANZCTR
Registration number
ACTRN12622000625774
Ethics application status
Approved
Date submitted
8/04/2022
Date registered
28/04/2022
Date last updated
25/11/2022
Date data sharing statement initially provided
28/04/2022
Type of registration
Prospectively registered
Titles & IDs
Public title
Analgesia for major abdominal surgery: A feasibility study using a combination of intrathecal and epidural morphine
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Scientific title
Analgesia for major abdominal surgery: A feasibility study using a combination of intrathecal and epidural morphine
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Secondary ID [1]
306878
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Postoperative pain
325979
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Quality of recovery
325980
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Condition category
Condition code
Anaesthesiology
323293
323293
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0
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Pain management
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Anaesthesiology
323294
323294
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0
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Anaesthetics
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
1. Epidural Morphine Group
o Combined spinal epidural prior to induction of anaesthesia
Single lumbar intrathecal injection of preservative-free morphine
• 200 mcg , or 300 mcg for upper gastrointestinal surgery, in 2 - 4 ml 0.5% bupivacaine
Lumbar epidural catheter inserted, labelled and capped
o Intravenous fentanyl PCA (fPCA) post op with 10 – 20 mcg bolus / 5 - 10 minute lockout
o After 24 hours Acute Pain Service (APS) to test the epidural with 4 ml 2% lignocaine with 1 in 200000 Adrenaline to ensure correct placement with onset of a sensory block, and exclusion of spinal block
o APS to administer 3 mg of epidural morphine with 3 ml normal saline 0.9% flush.
o APS to repeat epidural bolus 12 – 24 hourly up until 5 days post procedure if required as long as pain NRS is 3 or greater at the time of review
• Intravenous fentanyl PCA to continue whilst epidural in-situ
• Rescue analgesia for NRS pain score > 4
o Contact APS, to consider clinical situation, no restrictions as per protocol
o APS to consider the clinical situation and the following options first, prior to following local protocols to control pain
- Recommencing IV fPCA if ceased
- Epidural bolus fentanyl 50 mcg
- Oral analgesic including opioids
o Following rescue analgesia, respiratory observations every 30 minutes for the two hours after administration, then back to hourly PCA observations
• If sedation score > 2 or RR < 8, remove intravenous fentanyl PCA, alert medical team and consider naloxone administration.
• Epidural site must be checked twice daily. Should fever, or signs of local site infection occur, the epidural catheter must be removed following timing of anticoagulation confirmed, and consultation with APS
Protocol adherence will be determined following completion of patient follow up at 30 days upon review of the electronic medical record
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Intervention code [1]
323339
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Treatment: Drugs
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Comparator / control treatment
Control group
Single lumbar intrathecal injection of preservative-free morphine prior to induction of anaesthesia
• 200 mcg , or 300 mcg for upper gastrointestinal surgery in 2 - 4 ml 0.5% bupivacaine
o Intravenous fentanyl PCA (fPCA) post op with 10 – 20 mcg bolus / 5 - 10 minute lockout
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Control group
Active
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Outcomes
Primary outcome [1]
331024
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To measure the ability to recruit eligible patients into the study. Surveillance of surgical booking schedules will be used to screen for eligible patients. Criteria: The study protocol will be assessed as feasible if a recruitment rate of 50% of patients approached following the screening process is achieved. A record of those screened, approached and successfully recruited will be kept.
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Assessment method [1]
331024
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Timepoint [1]
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12 months after recruitment is commenced
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Primary outcome [2]
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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 the need for cross-over, of at least 80% is achieved. Confirmation of protocol adherence will be obtained through audit of the electronic medical record, confirming administration of intrathecal morphine, the use of fentanyl IV PCA and epidural morphine administration in the intervention group when clinical appropriate.
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Assessment method [2]
331025
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Timepoint [2]
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Postoperative day 5
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Secondary outcome [1]
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Patient recovery as assessed by QoR-15
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Assessment method [1]
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Timepoint [1]
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Measure QoR-15 on postoperative day 1
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Secondary outcome [2]
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Oral opioid equivalent consumption assessed by analysis of electronic medical record and PCA machine analytics
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Assessment method [2]
408518
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Timepoint [2]
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Cumulative daily amount up until postoperative day 5, or discharge if occurring earlier, as well as, hourly usage in relation to epidural morphine bolus, defined as 0-6hrs, 6-12hrs, 12-18hrs and 18-24hrs.
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Secondary outcome [3]
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Length of hospital stay as assessed by time from operation to discharge home. Data will be obtained from hospital records
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Assessment method [3]
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Timepoint [3]
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At time of discharge home or to another non-acute care facility
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Secondary outcome [4]
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Rest pain scores using numerical rating scale
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Assessment method [4]
408520
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Timepoint [4]
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In Post Anaesthetics Care Unit (PACU) and daily, recording the highest score for the previous 24hours
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Secondary outcome [5]
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Sedation score using a sedation score scale
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Assessment method [5]
408521
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Timepoint [5]
408521
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Recorded in the postanaesthetic care unit and the daily, recording the highest score for the previous 24 hours
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Secondary outcome [6]
408522
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Patient subjective experience of analgesia assessed using open ended questions.
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Assessment method [6]
408522
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Timepoint [6]
408522
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Prior to discharge from hospital
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Secondary outcome [7]
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Medical staff perspective on management of recruited patients measured using a short open ended questionnaire designed for this study
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Assessment method [7]
408523
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Timepoint [7]
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Immediately following completion of study recruitment
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Secondary outcome [8]
408524
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Distress level due to nausea, pruritus and pain using assessed using a numerical rating score.
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Assessment method [8]
408524
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Timepoint [8]
408524
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In PACU and once per day whilst an inpatient through to day 5
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Secondary outcome [9]
408525
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Respiratory depression as assess by respiratory rate <8 breaths per minute, oxygen saturations <90% or need to airway intervention or naloxone administration
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Assessment method [9]
408525
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Timepoint [9]
408525
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Any time point during admission post procedure until discharge from hospital
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Secondary outcome [10]
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Pruritus score as assessed by numerical rating score.
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Assessment method [10]
408526
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Timepoint [10]
408526
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In PACU and once per day whilst an inpatient through to day 5, recording highest score over previous 24 hours
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Secondary outcome [11]
408527
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Hypotension measured invasive monitoring i.e. arterial line, or non invasive e.g. sphygmomanometer, requiring intravenous fluid bolus or vasopressor
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Assessment method [11]
408527
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Timepoint [11]
408527
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Any time point during admission post procedure until discharge from hospital
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Secondary outcome [12]
408528
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Cumulative time/number of visits required of acute pain service to manage patients having epidural morphine determined through audit of electronic medical record identifying the APS consultations
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Assessment method [12]
408528
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Timepoint [12]
408528
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Until post operative day 5
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Secondary outcome [13]
408670
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Dynamic pain scores using numerical rating scale
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Assessment method [13]
408670
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Timepoint [13]
408670
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In Post Anaesthetics Care Unit (PACU) and daily, recording the highest score for the previous 24hours
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Eligibility
Key inclusion criteria
Eligible patients will be;
• > 18 years old
• Patients scheduled for elective major (> 2 hours surgical time) open abdominal surgery
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Minimum age
18
Years
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Maximum age
75
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
• Age >75 years
• Hypersensitivity reactions to any of the study drugs
• Contraindication to neuraxial (local site concerns, coagulopathy or untreated sepsis)
• Patient decline or inability to consent
• 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
• Contraindication to intrathecal morphine
• Lactating or pregnant women
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Computer generated randomisation
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
A formal sample size calculation has not been done, given this is a feasibility study and considering the characteristics of the study’s objectives. A year-long trial period is anticipated, with plans for around 80-100 patients to be enrolled. Hence, there will be approximately 40-50 patients in each arm.
Data will be expressed as percentages, means with standard deviations, and/or medians with interquartile ranges. Group comparisons will be described by point estimates with 95% confidence intervals.
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
1/11/2022
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Actual
25/10/2022
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Date of last participant enrolment
Anticipated
30/11/2023
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Actual
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Date of last data collection
Anticipated
30/12/2023
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Actual
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Sample size
Target
80
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Accrual to date
3
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
22175
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The Alfred - Melbourne
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Recruitment hospital [2]
22176
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Peter MacCallum Cancer Centre - Melbourne
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Recruitment postcode(s) [1]
37327
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3004 - Melbourne
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Funding & Sponsors
Funding source category [1]
311192
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Hospital
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Name [1]
311192
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Alfred Hospital
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Address [1]
311192
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55 Commerical Road, Prahran, 3004, Victoria
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Country [1]
311192
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Australia
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Primary sponsor type
Hospital
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Name
Alfred Health
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Address
55 Commercial Road, Prahran, 3004, Victoria
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Country
Australia
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Secondary sponsor category [1]
312563
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None
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Name [1]
312563
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Address [1]
312563
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Country [1]
312563
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
310724
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Alfred Hospital Human Ethics Research Committee
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Ethics committee address [1]
310724
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Department of Anaesthesiology and Perioperative Medicine, 55 Commercial Road, Prahran, 3004, Victoria
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Ethics committee country [1]
310724
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Australia
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Date submitted for ethics approval [1]
310724
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02/05/2022
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Approval date [1]
310724
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13/09/2022
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Ethics approval number [1]
310724
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Summary
Brief summary
Major abdominal surgery is a common procedure associated with significant postoperative pain and morbidity. Poorly controlled pain negatively impacts upon recovery following surgery. Intrathecal morphine is an increasingly popular alternative analgesic option in major abdominal surgery but has a limited duration of effect. Epidural morphine can be continued postoperatively for as long as the epidural catheter remains in situ. A direct comparison of epidural morphine and intravenous opioid PCA following preoperative intrathecal morphine for major abdominal surgery has not been conducted.
We believe epidural morphine will be superior to intravenous opioid PCA 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
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
118646
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Dr Katrina Pirie
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Address
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Alfred Health
55 Commercial Road,
Prahran, 3004, Victoria
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Country
118646
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Australia
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Phone
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+61 3 9076 3176
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Fax
118646
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Email
118646
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[email protected]
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Contact person for public queries
Name
118647
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Dr Katrina Pirie
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Address
118647
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Alfred Health
55 Commercial Road,
Prahran, 3004, Victoria
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Country
118647
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Australia
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Phone
118647
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+61 3 9076 3176
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Fax
118647
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Email
118647
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[email protected]
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Contact person for scientific queries
Name
118648
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Dr Katrina Pirie
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Address
118648
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Alfred Health
55 Commercial Road,
Prahran, 3004, Victoria
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Country
118648
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Australia
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Phone
118648
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+61 3 9076 3176
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Fax
118648
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Email
118648
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Specific requests for de-identified data collected
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When will data be available (start and end dates)?
Following completion, data analysis and publication and for up to 10 years
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Available to whom?
Upon request following submission to ethics and with a statistical analysis plan
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Available for what types of analyses?
As per statistical plan of those applying for the data
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How or where can data be obtained?
Upon request as above, email
[email protected]
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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.
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