Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001609842p
Ethics application status
Not yet submitted
Date submitted
15/09/2021
Date registered
26/11/2021
Date last updated
26/11/2021
Date data sharing statement initially provided
26/11/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Regional vs Intravenous Lidocaine in Determining functional outcome after Lung Surgery (RIDDLE)
Scientific title
Regional vs IV LiDocaine in Determining functional outcome after Lung Surgery (RIDDLE)
Secondary ID [1] 305320 0
None
Universal Trial Number (UTN)
Trial acronym
RIDDLE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain management 323636 0
Condition category
Condition code
Anaesthesiology 321174 321174 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Erector Spinae Plane (ESP) block: An ESP block with catheter will be placed in the operating theatre with 40 mL of 0.2% ropivacaine bolus at the end of operation followed by 0.2% ropivacaine bolus every 4 hours. Catheter will be removed at 24 hours from the time of post anaesthetic care unit (PACU) arrival.
Intervention code [1] 321723 0
Treatment: Other
Intervention code [2] 322025 0
Treatment: Drugs
Comparator / control treatment
Intravenous lidocaine (IVLA): A bolus of 1.5mg/kg of lidocaine is given at induction followed by 0.5mg/kg/hr infusion. Infusion will cease at 24 hours from the time of post anaesthetic care unit (PACU) arrival.
Control group
Active

Outcomes
Primary outcome [1] 328964 0
Amount of fentanyl used in the PCA in 24 hours after arrival in PACU determined by audit of medication infusion records
Timepoint [1] 328964 0
First 24 hours after arrival in PACU
Primary outcome [2] 329329 0
Serum concentration of lidocaine at 24 hours after patient arrival in PACU determined by laboratory measurement of lidocaine concentration in patient's serum
Timepoint [2] 329329 0
24 hours after arrival in PACU
Primary outcome [3] 329330 0
SF 36 score at study enrolment in pre-admission clinic and on postoperative day 21 determined by patient in person or phone patient interview using the SF 36 questionnaire
Timepoint [3] 329330 0
At study enrolment in pre-admission clinic and on postoperative day 21
Secondary outcome [1] 400952 0
Adverse events relating to each analgesic method determined by data-linkage to medical records. Adverse events can include drowsiness, tingling or numbness, mild visual changes, ringing in the ears, abnormal heart rhythm, and seizures.
Timepoint [1] 400952 0
Data obtained during 30 postoperative days
Secondary outcome [2] 402159 0
Length of stay in PACU determined by data-linkage to medical records.
Timepoint [2] 402159 0
At time of discharge from PACU
Secondary outcome [3] 402160 0
Renal complications determined by data-linkage to medical records indicating need for continuous renal replacement therapy (CRRT) or intermittent hemodialysis (IHD)
Timepoint [3] 402160 0
Data obtained during 30 postoperative days
Secondary outcome [4] 402161 0
Length of stay in hospital determined by data-linkage to medical records.
Timepoint [4] 402161 0
At time of discharge from the hospital
Secondary outcome [5] 402162 0
Unplanned readmissions to hospital during the first 30 postoperative days determined by data-linkage to medical records.
Timepoint [5] 402162 0
Data obtained during 30 postoperative days

Eligibility
Key inclusion criteria
• Age >= 18 years old
• American Society of Anesthesiologists (ASA) status I, II, III
• Elective thoracic surgeries via video assisted thoracic (VAT) approach
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Unable to provide written informed consent
• Documented diagnosis of chronic pain or recreational drug use
• Known hypersensitivity to amide local anaesthetic
• Pregnant or lactating women
• Epilepsy
• Patients with abnormal liver function test
• Patients with arrhythmia, complete bundle branch block, prolonged QT interval
• BMI >= 40kg/m2
• Patients admitting to intensive care unit postoperatively

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)
Patients will be randomised 1:1 to either of the intervention arms using block randomisation.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
This pilot study will inform a feasibility assessment and sample size needed to a definitive
phase III RCT which ultimately will investigate.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2022
Actual
Date of last participant enrolment
Anticipated
1/07/2022
Actual
Date of last data collection
Anticipated
1/08/2022
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 20524 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 35303 0
6150 - Murdoch

Funding & Sponsors
Funding source category [1] 309685 0
Charities/Societies/Foundations
Name [1] 309685 0
Heart and Lung Research Institute Western Australia (HLRI WA)
Country [1] 309685 0
Australia
Primary sponsor type
Government body
Name
South Metropolitan Health Services
Address
14 Barry Marshall Parade, Murdoch WA 6150
Country
Australia
Secondary sponsor category [1] 310706 0
None
Name [1] 310706 0
Address [1] 310706 0
Country [1] 310706 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 309452 0
South metropolitan health services human research ethics committee
Ethics committee address [1] 309452 0
14 Barry Marshall Parade, Murdoch WA 6150
Ethics committee country [1] 309452 0
Australia
Date submitted for ethics approval [1] 309452 0
15/12/2021
Approval date [1] 309452 0
Ethics approval number [1] 309452 0

Summary
Brief summary
Substantial persistent pain after major lung surgery remains a significant problem despite new methods of pain control with up to one third of these patients still experiencing pain severe enough to affect their daily living months after lung surgeries. In addition to its effect on the essential daily tasks of living, long term pain is also known to cause mental health problems and lead to long-term opioid dependency further affecting the quality of life of patients and incurring extra cost to the healthcare system.

Optimization of the acute pain control immediately after surgery is the single most important factor affecting the development of long-term pain. One of the more recently developed techniques of pain control is a technique called regional anaesthesia whereby local anaesthetic is injected next to the nerves supplying that area of the body with the surgical incision, thereby effectively ‘numbing’ them to reduce the pain felt by the patients. An alternative pain relief technique involves giving a small dose of local anaesthetic, such as lidocaine, directly into the veins of the patient. This method can offer a much more predictable pain relief than a regional anaesthetic technique because it does not require the specialized technical skills to perform and hence it may have a great potential for general use to reduce pain effectively. Nonetheless, administering local anaesthetic agent, such as lidocaine, directly into the blood can still have some rare side effect including drowsiness and changes in heart rhythm and blood pressure.

In this study, we aim to compare these two pain relief methods, not only to assess whether
one is better than the other in relieving pain, but also whether one is better to allow the patients to recover from surgery.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 114210 0
Dr Ann Ngui
Address 114210 0
Ann Ngui
Fiona Stanley Hospital
5 Robin Warren Dr, Murdoch WA 6150
Country 114210 0
Australia
Phone 114210 0
+61 0861526078
Fax 114210 0
Email 114210 0
[email protected]
Contact person for public queries
Name 114211 0
Dr Ann Ngui
Address 114211 0
Ann Ngui
Fiona Stanley Hospital
5 Robin Warren Dr, Murdoch WA 6150
Country 114211 0
Australia
Phone 114211 0
+61 0861526078
Fax 114211 0
Email 114211 0
[email protected]
Contact person for scientific queries
Name 114212 0
Dr Ann Ngui
Address 114212 0
Ann Ngui
Fiona Stanley Hospital
5 Robin Warren Dr, Murdoch WA 6150
Country 114212 0
Australia
Phone 114212 0
+61 0861526078
Fax 114212 0
Email 114212 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?
All of the individual participant data collected during the trial, after de-identification
When will data be available (start and end dates)?
Data will be available after publication, no specific start or end dates determined.
Available to whom?
Case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
Any purpose
How or where can data be obtained?
Access subject to approvals by Principal Investigator:
Ann Ngui
[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.