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Trial registered on ANZCTR


Registration number
ACTRN12624000714583
Ethics application status
Approved
Date submitted
27/05/2024
Date registered
11/06/2024
Date last updated
3/11/2024
Date data sharing statement initially provided
11/06/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Pain Relief for Lung Transplantation
Scientific title
Post-Operative analgesia in Lung Allograft Recipients (POLAR): a randomised controlled trial investigating efficacy in aiding quality of recovery following transplantation
Secondary ID [1] 311907 0
None
Universal Trial Number (UTN)
Trial acronym
POLAR: Post-Operative analgeisa in Lung Allograft Recipients
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lung transplantation 333493 0
Acute post-operative pain 333494 0
Post thoracotomy pain syndrome 333495 0
Condition category
Condition code
Anaesthesiology 330171 330171 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Cryoanalgesia:

This procedure uses the cryoSPHERE (Atricure, USA) which is in routine use within St Vincent’s Public Hospital and involves freezing the intercostal nerves in the - 50 to -70°C range from within the surgical wound. Axons within the intercostal nerve that send pain signals are destroyed distal to the cryoablation site. The tubule structures (epineurium, perineurium, and endoneurium) of the nerve remain intact allowing the axons to regenerate and nerve function to resume over the course of roughly 1-3 months. Cryoablation will be performed by a member of the surgical team prior to wound closure. The intercostal nerve at the level of the anterior thoracotomy incision (T4 – T5) as well as one level superior and two levels inferior will be performed. Each level takes 120 seconds to ablate so the time involved is approximately 8 minutes for a unilateral and 16 minutes for a bilateral transplant. Administration and duration of cryoanalgesia will be documented in participants' medical records.
Intervention code [1] 328377 0
Treatment: Devices
Comparator / control treatment
Serratus Anterior Plane Block (SAPB) catheter placement with ropivacaine 0.2% programmed intermittent bolus local anaesthetic:

This procedure involves placement of either unilateral (for single lung transplant) or bilateral (for bilateral lung transplant) Pajunk E-Cath (PajunkR, USA) indwelling catheter into the anatomical plane deep to the serratus anterior muscle on the anterior chest wall under ultrasound guidance. This will occur following lung transplantation while the patient is still anaesthetised, either prior to transfer to the Intensive Care Unit or once the patient has been stabilised in the Intensive Care Unit. It will be performed by a member of the anaesthetic team and takes approximately 15 minutes for a unilateral and 25 minutes for a bilateral transplantation. The E-Cath will be connected to an ambIT electronic pump (BTC Health, Australia) which will be programmed to deliver a programmed intermittent bolus (PIB) of Ropivacaine 0.2% as per an established St Vincent’s Public Hospital protocol (Peripheral Nerve Infusion Policy).

Ropivacaine is a local anaesthetic that, when bolused regularly through an SAPB catheter, provides analgesia in the distribution of the anterior thoracotomy wound which is the standard incision for lung transplantation. It does this by blocking the lateral cutaneous branches of the T2 – T6 intercostal nerves, the long thoracic nerve, and the dorsal thoracic nerve on the ipsilateral side of insertion.
Control group
Active

Outcomes
Primary outcome [1] 337928 0
Patient-reported quality of recovery
Timepoint [1] 337928 0
Weeks 1 and 2 post-transplant
Secondary outcome [1] 433757 0
Patient-reported pain
Timepoint [1] 433757 0
Weeks 1, 2, 4 and 12 post transplant
Secondary outcome [2] 433758 0
Patient-reported sensory disturbance
Timepoint [2] 433758 0
Weeks 1, 2, 4 and 12 post transplant
Secondary outcome [3] 433760 0
Opioid use
Timepoint [3] 433760 0
Weeks 1, 2, 4 and 12 post transplant as well as day of discharge from hospital
Secondary outcome [4] 433761 0
Hospital length of stay
Timepoint [4] 433761 0
Day of discharge
Secondary outcome [5] 433762 0
Length of ICU stay
Timepoint [5] 433762 0
Day of ICU discharge
Secondary outcome [6] 433763 0
Number of hours ventilated after arrival in ICU
Timepoint [6] 433763 0
Day of ICU discharge
Secondary outcome [7] 433764 0
Lung function
Timepoint [7] 433764 0
Weeks 4 and 12 post transplant
Secondary outcome [8] 433765 0
Aerobic exercise capacity
Timepoint [8] 433765 0
Weeks 4 and 12 post transplant
Secondary outcome [9] 433766 0
Survival at 12 weeks
Timepoint [9] 433766 0
12 weeks post transplant

Eligibility
Key inclusion criteria
Aged 18 years or older
Undergoing a single or double lung transplant at St Vincent’s Public Hospital Sydney
Able and willing to provide written informed consent, including sufficient English skills
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Allergy to local anaesthesia
Undergoing a joint heart and lung transplant
Use of clamshell incision

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 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
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The primary outcome is QoR-15 scores between the 2 groups (SAPB catheter and cryoanalgesia). As a change in QoR-15 score of 8 is considered clinically meaningful, we calculated a sample size to compare QoR-15 scores of 100 (SD=9) in 1 group to a score of 108 (SD=10) in the second group. Using an alpha of 0.05 in a two-sided test and 80% power, a total of 48 participants were required. Power analyses were conducted using G*Power software, version 3.1.9.7 (Heinrich-Heine-Universität Düsseldorf, Düsseldorf, Germany). This more conservative difference of 8 was employed in sample size calculations, however, updated analyses in the development of the QoR-15 indicate that a change in score of 6 is clinically meaningful (Myles & Myles, 2021).

Analyses will be performed in accordance with intention to-treat-principle in which patients are analysed according to the group they are randomised to. A t-test will be used to analyse QoR-15 to within an equivalence margin of 6 in week 1 between the groups. A multilevel model will be used to model the Pain Numeric Rating Scale at weeks 1, 2, 4 and 12, with the main comparison between the groups occurring at week 12. Demographic and clinical variables will be used analysed for balance between the 2 groups. Adjustment for confounders will be considered based on any observed imbalances and appropriateness of the outcome, as part of sensitivity analysis of the results.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
17/06/2024
Actual
11/06/2024
Date of last participant enrolment
Anticipated
16/06/2025
Actual
Date of last data collection
Anticipated
15/09/2025
Actual
Sample size
Target
48
Accrual to date
19
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 26382 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment postcode(s) [1] 42355 0
2010 - Darlinghurst

Funding & Sponsors
Funding source category [1] 316368 0
Hospital
Name [1] 316368 0
St Vincent's Public Hospital Sydney
Country [1] 316368 0
Australia
Primary sponsor type
Hospital
Name
St Vincent’s Public Hospital Sydney
Address
Country
Australia
Secondary sponsor category [1] 318445 0
None
Name [1] 318445 0
Address [1] 318445 0
Country [1] 318445 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315076 0
St Vincent’s Hospital Human Research Ethics Committee
Ethics committee address [1] 315076 0
https://svhs.org.au/home/research-education/research-office
Ethics committee country [1] 315076 0
Australia
Date submitted for ethics approval [1] 315076 0
29/01/2024
Approval date [1] 315076 0
06/03/2024
Ethics approval number [1] 315076 0
2024/ETH00129

Summary
Brief summary
Lung transplantation aims to extend the lifespan and improve the quality of life for people living with end-stage lung disease. Most lung transplants now involve thoracotomy incisions between two ribs and spreading of the ribs to allow for removal, insertion, and attachment of lungs. Thoracotomies can be very painful for weeks and in many patients can result in longer term nerve pain that can have significant negative impacts on quality of life. Two novel techniques to manage pain for lung transplant patients have been introduced to supplement morphine-type pain medications: a catheter that delivers local anaesthetic to the area and cryotherapy to temporarily freeze and numb the nerves in the area. This study aims to assess if either technique leads to a shorter time in intensive care, better recovery, and better pain relief from the incision in the short term and potential nerve pain in the longer term. It is hypothesised that there will be no differences between these two techniques. The study will also be looking for side effects with each technique.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 133598 0
A/Prof Jennifer Stevens
Address 133598 0
St Vincent's Public Hospital Anaesthetics Department, 390 Victoria Street, Darlinghurst NSW 2010
Country 133598 0
Australia
Phone 133598 0
+61 02 8382 3202
Fax 133598 0
Email 133598 0
[email protected]
Contact person for public queries
Name 133599 0
Jennifer Stevens
Address 133599 0
St Vincent's Public Hospital Anaesthetics Department, 390 Victoria Street, Darlinghurst NSW 2010
Country 133599 0
Australia
Phone 133599 0
+61 02 8382 3202
Fax 133599 0
Email 133599 0
[email protected]
Contact person for scientific queries
Name 133600 0
Jennifer Stevens
Address 133600 0
St Vincent's Public Hospital Anaesthetics Department, 390 Victoria Street, Darlinghurst NSW 2010
Country 133600 0
Australia
Phone 133600 0
+61 02 8382 3202
Fax 133600 0
Email 133600 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Aggregate data will be provided if requested


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.