Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001018303
Ethics application status
Approved
Date submitted
11/07/2017
Date registered
14/07/2017
Date last updated
22/08/2022
Date data sharing statement initially provided
22/08/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
The CHAmPION Trial - A comparison of two types of regional anaesthesia for post-operative pain in patients having hepatobiliary and pancreatic surgery
Scientific title
The effect of Continuous subcostal transversus abdominis plane block on post-operative pain in HepAtobiliary and Pancreatic surgery patients compared to Intrathecal mOrphiNe
Secondary ID [1] 292409 0
None
Universal Trial Number (UTN)
U1111-1199-1395
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post-operative pain 303989 0
Hepatobiliary surgery 303990 0
Pancreatic surgery 304010 0
Condition category
Condition code
Anaesthesiology 303329 303329 0 0
Pain management
Surgery 303341 303341 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Abdominal wall regional anesthesia in the form of local anaesthetic bolused via ultrasound placed subcostal transversus abdominis plane (S-TAP) catheters, after open hepatobiliary and pancreatic surgery. This will be administered immediately at completion of surgery while patient is still in the operating room.

Detailed description of technique:
Spinal with 2ml of 0.5% bupivacaine plus 0.3mL saline + Surgically placed TAP and rectus sheath catheters, each with a 30ml (to a maximum 1mL/kg) hand bolus of 0.2% ropivacaine at the end of surgery, followed by 20mL (to a maximum 0.65mL/kg) of 0.2% ropivacaine every 4 hours via a CADD®Solis pump for 72hours.
Intervention code [1] 298578 0
Treatment: Drugs
Comparator / control treatment
The intervention will be compared with the current standard of care, which is intrathecal morphine (ITM) for post-operative pain relief for hepatobiliary and pancreatic surgery. This will be administered immediately at completion of surgery while patient is still in the operating room.

Detailed description of control technique:
Spinal anaesthetic with 2ml of 0.5% bupivacaine plus 150mcg intrathecal morphine + Surgically placed TAP and rectus sheath catheters, each with a 30mL (to a maximum 1mL/kg)) hand bolus of saline at the end of surgery, followed by 20mL (to a maximum 0.65mL/kg) of saline every 4 hours via a CADD®Solis pump for 72hours.
Control group
Active

Outcomes
Primary outcome [1] 302720 0
Post-operative pain intensity and interference measured by the modified pain brief inventory (mBPI) score (composite outcome)
Timepoint [1] 302720 0
48 hours post-operatively, after the first abdominal catheter bolus
Secondary outcome [1] 336804 0
mBPI intensity and interference scores (composite outcome)
Timepoint [1] 336804 0
immediately post-op, 24 hours, 7 days, and 90 days after the first abdominal catheter bolus
Secondary outcome [2] 336805 0
mBPI 'pain at its worst' score
Timepoint [2] 336805 0
immediately post-op, 24 hours, 48 hours, 7 days, and 90 days after the first abdominal catheter bolus
Secondary outcome [3] 336806 0
Total opioid requirements, referenced to total equipotent IV morphine dose collected from patient medical records.
Timepoint [3] 336806 0
At discharge from recovery, 24 hours, 48 hours, after the first abdominal catheter bolus
Secondary outcome [4] 336807 0
Quality of recovery score using the Quality of Recovery-15 questionnaire
Timepoint [4] 336807 0
48 hours after the first abdominal catheter bolus
Secondary outcome [5] 336808 0
Timed Up and Go test time
Timepoint [5] 336808 0
Within 48 to 72 hours of the first abdominal catheter bolus
Secondary outcome [6] 336809 0
Disability free survival measured using the WHO-DAS 2.0 questionnaire score
Timepoint [6] 336809 0
90 days post-opearatively
Secondary outcome [7] 336810 0
Incidence of serious adverse drug reactions or serious adverse events through comprehensive adverse event reporting.
Serious adverse drug reaction or serious adverse event is defined by and untowards event that may be life-threatening, prolongs or requires hospitalisation, persistent or significant disability incapacity, fatal, or otherwise clinically important event determined by the investigator.
Timepoint [7] 336810 0
90 days post-operatively

Eligibility
Key inclusion criteria
Patients undergoing open hepatobiliary and/or pancreatic surgery at Auckland City Hospital
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Contraindication to spinal block at the discretion of the treating anaesthetist, including coagulopathy (INR >/= 1.4 or platelets < 80 x 10^9/L) or abnormality precluding spinal block
2) Inability to identify with ultrasound the appropriate tissue planes for safe regional catheter placement
3) Patient refusal
4) Objection of the treating anaesthetist or surgeon for the patient to be enrolled into the study

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)
Randomisation will be done by the use of sealed, opaque evelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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 3 / Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Suspended
Date of first participant enrolment
Anticipated
1/09/2017
Actual
30/01/2018
Date of last participant enrolment
Anticipated
Actual
3/04/2018
Date of last data collection
Anticipated
Actual
1/08/2018
Sample size
Target
100
Accrual to date
4
Final
Recruitment outside Australia
Country [1] 9045 0
New Zealand
State/province [1] 9045 0

Funding & Sponsors
Funding source category [1] 296959 0
Charities/Societies/Foundations
Name [1] 296959 0
A+ Trust
Country [1] 296959 0
New Zealand
Primary sponsor type
Individual
Name
Dr Helen Lindsay
Address
Department of Anaesthesia
Auckland City Hospital
2 Park Rd, Grafton
Auckland 1023
Country
New Zealand
Secondary sponsor category [1] 295966 0
None
Name [1] 295966 0
Address [1] 295966 0
Country [1] 295966 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298165 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 298165 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 298165 0
New Zealand
Date submitted for ethics approval [1] 298165 0
21/07/2017
Approval date [1] 298165 0
25/10/2017
Ethics approval number [1] 298165 0
17/STH/197

Summary
Brief summary
This study aims to compare the efficacy and safety of two methods of pain relief after major abdominal surgery: intrathecal morphine (IT) standard of care verses abdominal wall regional anaesthesia.
The abdominal wall regional anaesthesia is a bolus injection of local anaesthetic via ultrasound placed subcostal transversus abdominis plane (S-TAP) catheters. Although IT is the current standard practice for pain relief in this type of surgery, it has also been associated with significant complications including nausea, vomiting, respiratory depression, and hypotension. There is increasing evidence that S-TAP may be able to provide equally satisfactory pain relief and associated with fewer complications. However, no study has been conducted that comprehensively compared using multidimensional analysisto assess the pain control achieved, as well as safety, of these two techniques.
This study is a randomised controlled triple blind control trial. Patients having open hepatobiliary and pancreatic (HPB) surgery at Auckland City Hospital will be randomised to receive either IT or S-TAP for pain relief after surgery. Subjects, treating physicians and investigator/outcome assessors will be blinded to the randomisation results. Patients will be followed up to assess:
1)Pain and analgesia requirement in the first 48 hours after surgery
2)Physical assessment using the Time Up and Go test at 72 hours after surgery
3) Pain assessment at 7 days after surgery
4) Change in disability free survival (WHO-DAS questionnaire)and pain assessment at 90 days after surgery
The study also includes comprehensive adverse event reporting.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 76194 0
Dr Helen Lindsay
Address 76194 0
Department of Anaesthesia
Level 8 Support Building
Auckland City Hospital
2 Park Rd, Grafton
Auckland, 1023
Country 76194 0
New Zealand
Phone 76194 0
+64 27 778 2061
Fax 76194 0
Email 76194 0
HelenL@adhb.govt.nz
Contact person for public queries
Name 76195 0
Ms Davina McAllister
Address 76195 0
Department of Anaesthesia
Auckland City Hospital
Level 8 Support Building
2 Park Rd, Grafton
Auckland 1023
Country 76195 0
New Zealand
Phone 76195 0
+64 9 3757095
Fax 76195 0
Email 76195 0
DavinaMS@adhb.govt.nz
Contact person for scientific queries
Name 76196 0
Dr Helen Lindsay
Address 76196 0
Department of Anaesthesia
Level 8 Support Building
Auckland City Hospital
2 Park Rd, Grafton
Auckland, 1023
Country 76196 0
New Zealand
Phone 76196 0
+64 27 778 2061
Fax 76196 0
Email 76196 0
HelenL@adhb.govt.nz

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 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.