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Trial registered on ANZCTR


Registration number
ACTRN12624001346561p
Ethics application status
Submitted, not yet approved
Date submitted
16/08/2024
Date registered
7/11/2024
Date last updated
7/11/2024
Date data sharing statement initially provided
7/11/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Methadone IV versus Paravertebral Catheter Block for analgesia in Video Assisted Thoracoscopic Surgery
Scientific title
Intravenous Methadone versus Paravertebral Catheter Block for analgesia in Video Assisted Thoracoscopic Surgery
Secondary ID [1] 312720 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
MIVATS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
post-operative pain post thoracic surgery 334742 0
Condition category
Condition code
Anaesthesiology 331377 331377 0 0
Pain management
Surgery 332070 332070 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants will undergo a Video-Assisted Thoracoscopic Surgery (VATS) lobectomy to remove one or more segments of lung. The VATS lobectomy will be performed by a cardiothoracic surgeon and may take approximately 2-3 hours. This procedure may be performed in combination with other surgical procedures. Anaesthetic and procedural records will be used to monitor adherence to the treatment arms.

Three treatment arms are to be used in this research project, but only two treatment arms include the intervention (Arm 1 and 3).

Arm 1: Intravenous Methadone on Induction of anaesthesia (IVMI):
• 0.2mg/kg (max 20mg) Methadone administered intravenously on induction of General Anaesthesia (GA) as the sole opiate for case

Arm 2: Standard Care
• Paravertebral catheter block: Infusion of 0.2 % Ropivacaine via paravertebral catheter
o Initial loading dose of 2-3mg/kg
o intermittent mandatory bolus of between 0.25mg/kg every 4 hours
• Fentanyl may additionally be administered intravenously with dosage determined by the anaesthetist according to patient factors – A maximum dose of 500mcg will be administered intraoperatively.

Arm 3: Combination
• 0.2mg/kg Methadone administered intravenously on induction of general anaesthesia
• Paravertebral catheter block as for Standard of Care

The paravertebral catheters will remain in situ with intermittent mandatory bolus of 0.2% Ropivacaine for the duration of the procedure and recovery until deemed no longer required by the treating team or Acute Pain Service (APS).
Intervention code [1] 329243 0
Treatment: Drugs
Comparator / control treatment
Arm 2 is the control/comparator treatment arm

Arm 2:. 2. Standard Care (SC):
• Paravertebral catheter block: Infusion of 0.2 % Ropivacaine via paravertebral catheter
o Initial loading dose of 2-3mg/kg
o intermittent mandatory bolus of between 0.25mg/kg every 4 hours
• Fentanyl may additionally be administered intravenously with dosage determined by the anaesthetist according to patient factors – A maximum dose of 500mcg will be administered intraoperatively.

The paravertebral block will be commenced by the anaesthetist following induction as per Standard of Care. The paravertebral catheter will remain in situ with intermittent mandatory bolus of 0.2% Ropivacaine for the duration of the procedure and recovery until deemed no longer required by the treating team or the Acute Pain Service (APS).
Control group
Active

Outcomes
Primary outcome [1] 339059 0
Patient reported pain revels
Timepoint [1] 339059 0
Postoperative Day 1, 3, 5, and on day of discharge
Primary outcome [2] 339062 0
Activity level
Timepoint [2] 339062 0
Postoperative Day 1, 3, 5, and day of discharge
Primary outcome [3] 339063 0
Perception of sleep
Timepoint [3] 339063 0
Postoperative Day 1, 3, 5 and on day of discharge
Secondary outcome [1] 438429 0
Need for naloxone post procedure
Timepoint [1] 438429 0
From Post Anaesthetic Care Unit (PACU) up until day of discharge
Secondary outcome [2] 438430 0
Need for ICU Admission
Timepoint [2] 438430 0
From PACU until day of discharge
Secondary outcome [3] 438431 0
Fentanyl Protocol dose in recovery
Timepoint [3] 438431 0
In PACU
Secondary outcome [4] 438432 0
As required (PRN) opiate dose until discharge
Timepoint [4] 438432 0
From PACU until day of discharge
Secondary outcome [5] 438433 0
Oral morphine equivalents on discharge
Timepoint [5] 438433 0
On discharge
Secondary outcome [6] 438434 0
Theatre Times
Timepoint [6] 438434 0
Day of Procedure
Secondary outcome [7] 438435 0
Hospital length of stay
Timepoint [7] 438435 0
Day of discharge
Secondary outcome [8] 440802 0
Readmission to hospital
Timepoint [8] 440802 0
Until day 30 post-surgery.
Secondary outcome [9] 440805 0
Respiratory complications
Timepoint [9] 440805 0
From day of surgery until discharge
Secondary outcome [10] 440806 0
30 day mortality
Timepoint [10] 440806 0
Day 30 post-surgery
Secondary outcome [11] 441500 0
Incentive Spirometry Measures
Timepoint [11] 441500 0
Measured on Post Operative Day 1, 3, 5, and on day of discharge

Eligibility
Key inclusion criteria
• Undergoing a VATS lobectomy
• Adult patients aged 18 – 80yo.
• Able and willing to provide informed consent.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Paediatric patients aged <18, or patients aged >80yo.
• Primary planned/unplanned open surgery.
• Prior adverse reaction to methadone or local anaesthesia.
• Chronic pain requiring gabapentinoids or opiates.
• Current use of methadone or naltrexone for opioid use disorder.
• Surgery lasting less than 1 hour.
• Unable or unwilling to provide informed consent.

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
This study will include 90 participants.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/12/2024
Actual
Date of last participant enrolment
Anticipated
1/12/2025
Actual
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 26917 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 42981 0
6150 - Murdoch

Funding & Sponsors
Funding source category [1] 317150 0
Government body
Name [1] 317150 0
South Metropolitan Health Service
Country [1] 317150 0
Australia
Primary sponsor type
Government body
Name
South Metropolitan Health Service
Address
Country
Australia
Secondary sponsor category [1] 319417 0
Hospital
Name [1] 319417 0
Fiona Stanley Hospital
Address [1] 319417 0
Country [1] 319417 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 315901 0
South Metropolitan Health Service Human Research Ethics Committee
Ethics committee address [1] 315901 0
Ethics committee country [1] 315901 0
Australia
Date submitted for ethics approval [1] 315901 0
30/09/2024
Approval date [1] 315901 0
Ethics approval number [1] 315901 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 136150 0
Dr Warren Pavey
Address 136150 0
Fiona Stanley Hospital, Level 2, 14 Barry Marshall Parade, MURDOCH WA 6150
Country 136150 0
Australia
Phone 136150 0
+61430 389 600
Fax 136150 0
Email 136150 0
warren.pavey@health.wa.gov.au
Contact person for public queries
Name 136151 0
Rebecca Hahn
Address 136151 0
Fiona Stanley Hospital, Level 4, 14 Barry Marshall Parade, MURDOCH WA 6150
Country 136151 0
Australia
Phone 136151 0
+61 08 6152 5944
Fax 136151 0
Email 136151 0
rebecca.hahn@health.wa.gov.au
Contact person for scientific queries
Name 136152 0
Warren Pavey
Address 136152 0
Fiona Stanley Hospital, Level 2, 14 Barry Marshall Parade, MURDOCH WA 6150
Country 136152 0
Australia
Phone 136152 0
+61430 389 600
Fax 136152 0
Email 136152 0
warren.pavey@health.wa.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 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.