ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

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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]

None

Universal Trial Number (UTN)

Trial acronym

RIDDLE

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Pain management

Condition category

Condition code

Anaesthesiology

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]

Treatment: Other

Intervention code [2]

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]

Amount of fentanyl used in the PCA in 24 hours after arrival in PACU determined by audit of medication infusion records

Timepoint [1]

First 24 hours after arrival in PACU

Primary outcome [2]

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]

24 hours after arrival in PACU

Primary outcome [3]

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]

At study enrolment in pre-admission clinic and on postoperative day 21

Secondary outcome [1]

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]

Data obtained during 30 postoperative days

Secondary outcome [2]

Length of stay in PACU determined by data-linkage to medical records.

Timepoint [2]

At time of discharge from PACU

Secondary outcome [3]

Renal complications determined by data-linkage to medical records indicating need for continuous renal replacement therapy (CRRT) or intermittent hemodialysis (IHD)

Timepoint [3]

Data obtained during 30 postoperative days

Secondary outcome [4]

Length of stay in hospital determined by data-linkage to medical records.

Timepoint [4]

At time of discharge from the hospital

Secondary outcome [5]

Unplanned readmissions to hospital during the first 30 postoperative days determined by data-linkage to medical records.

Timepoint [5]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

Fiona Stanley Hospital - Murdoch

Recruitment postcode(s) [1]

6150 - Murdoch

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Heart and Lung Research Institute Western Australia (HLRI WA)

Address [1]

5 Robin Warren Dr, Murdoch WA 6150

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Not yet submitted

Ethics committee name [1]

South metropolitan health services human research ethics committee

Ethics committee address [1]

14 Barry Marshall Parade, Murdoch WA 6150

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

15/12/2021

Approval date [1]

Ethics approval number [1]

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

Dr Ann Ngui

Address

Ann Ngui
Fiona Stanley Hospital
5 Robin Warren Dr, Murdoch WA 6150

Country

Australia

Phone

+61 0861526078

Fax

Mau-Hing.Ngui@health.wa.gov.au

Contact person for public queries

Name

Ann Ngui

Address

Ann Ngui
Fiona Stanley Hospital
5 Robin Warren Dr, Murdoch WA 6150

Country

Australia

Phone

+61 0861526078

Fax

Mau-Hing.Ngui@health.wa.gov.au

Contact person for scientific queries

Name

Ann Ngui

Address

Ann Ngui
Fiona Stanley Hospital
5 Robin Warren Dr, Murdoch WA 6150

Country

Australia

Phone

+61 0861526078

Fax

Mau-Hing.Ngui@health.wa.gov.au

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
Mau-Hing.Ngui@health.wa.gov.au

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.

Trial Review

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