Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001626257
Ethics application status
Approved
Date submitted
17/09/2018
Date registered
3/10/2018
Date last updated
22/12/2020
Date data sharing statement initially provided
6/09/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
COntinuous or Bolus Administration of Local Anaesthesia for Thoracic Surgery : a single blinded randomized trial (COBALT Trial)
Scientific title
COntinuous or Bolus Administration of Local Anaesthesia for Thoracic Surgery : a single blinded randomized trial (COBALT Trial)
Secondary ID [1] 296110 0
None
Universal Trial Number (UTN)
Trial acronym
COBALT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Thoracic Surgery 309689 0
Pain Management 309690 0
Condition category
Condition code
Anaesthesiology 308494 308494 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
0.2% Ropivacaine at 0.15 ml/kg given every hour via Programmed intermittent boluses through a paravertebral catheter for three days post-operatively
Intervention code [1] 312443 0
Treatment: Drugs
Comparator / control treatment
0.2% Ropivacaine at 0.15 ml/kg/hr via Continuous Infusion through a paravertebral catheter for 3 days
Control group
Active

Outcomes
Primary outcome [1] 307470 0
Oxycodone consumption on day 1. This will be taken from the CADD-Solis pump which tracks PCA usage.. Electronic medical records will be checked for administration of other opiates (off protocol) and this will be converted to iv oxycodone equivalents as per ANZCA opioid calculator app v1.0 and added together.
Timepoint [1] 307470 0
Day 1 post surgery. From 8:00 am to 8:00 am
Secondary outcome [1] 351993 0
Oxycodone consumption on day 1. This will be taken from the CADD-Solis pump which tracks PCA usage.. Electronic medical records will be checked for administration of other opiates (off protocol) and this will be converted to iv oxycodone equivalents as per ANZCA opioid calculator app v1.0 and added together.
Timepoint [1] 351993 0
Day 2 and 3 post-operatively
Cumulative 72 hour dose. postoperatively
Secondary outcome [2] 351994 0
NRS Pain scores
Timepoint [2] 351994 0
Days 1 2 and 3 postoperatively
Secondary outcome [3] 351995 0
Respiratory Function tests performed by hand-held spirometry. Looking at % change in FEV1 from baseline.
Timepoint [3] 351995 0
Day 1 2 and 3 post-operatively
Secondary outcome [4] 351996 0
Length of stay, taken from medical records electronic database and calculated from the time of completion of surgery to hospital discharge.
Timepoint [4] 351996 0
Hospital stay
Secondary outcome [5] 351997 0
Persistent post surgical pain as measured by the Brief Pain Inventory short form
Timepoint [5] 351997 0
3 months post- surgery (+/- 7 days)
Secondary outcome [6] 352423 0
Respiratory Function tests performed by hand-held spirometry. Looking at % change in FVC from baseline.
Timepoint [6] 352423 0
Day 1 2 and 3 post-operatively

Eligibility
Key inclusion criteria
Patients undergoing Video-assisted thoracic surgery (VATS)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Age less than 18 years
- Indication for operation is Pleurodesis
- Contraindications or allergy to oxycodone or ropivacaine
- Failure of, or contraindication to surgical placement of an extrapleural catheter intraoperatively as assessed by thoracic surgeon.
- Pre-operative regular opioid use (>60 OMEDD)
- Other recent injuries or surgeries causing significant pain
- Weight >100kg
- Pre-operative coagulopathy: INR > 1.5, platelet count < 75 x 109/l
- Severe renal impairment: serum creatinine > 200ummol/l
- Severe hepatic insufficiency (bilirubin > 30umol/L, ALP > 300iu/L, ALT > 50iu/L, albumin < 25g/dL, INR > 1.5)
- American Society of Anesthesiologists (ASA) physical status IV or V
- Currently pregnant
- Cognitive impairment or intellectual disability precluding informed consent or satisfactory participation in the study
- Unable to speak English sufficiently to enable informed consent or understand instructions.
- Previous enrolment into our 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)
Allocation will be concealed by the use of shuffled sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation by shuffling unmarked sealed opaque envelopes.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample Size Estimation & Justification

We will recruit 120 patients in total, 60 patients in the PIB group and 60 patients in the continuous group.

This RCT will be conducted using an intention-to-treat (ITT) protocol. Therefore analysis of the results will be based on the initial treatment assignment and not on the treatment eventually received. In particular, if the extrapleural catheter is dislodged the opioid consumption will still be calculated for the remainder of the trial.
In the event that other opioid medications are given to the patients during the study period these will be converted to an equivalent dose of intravenous oxycodone using the ANZCA and FPM Endorsed Opioid calculator app.

Sample size for the study was calculated based on our retrospective study data evaluating patients undergoing VATS at Austin Hospital comparing continuous infusions to PIB. On the first postoperative day the infusion group had a mean OMEDD use of 173mg (SD 129mg). We chose a clinically significant difference as a 40% difference in opioid consumption. With an alpha value of 0.05 and a desired power of 0.80, we would need to 55 patients in each arm.
Allowing for dropout/withdrawal, 120 patients witll be randomised.

Statistical analysis will be performed using computerized software (Prism GraphPad v.6 and SPSS for Windows/MAC version 12.0). For all data that is non-normally distributed a Mann–Whitney test will be used, and normally distributed data will be compared using the Student T test. Ordinal and nominal data will be compared using Chi square analysis. A p-value <0.05 will be considered statistically significant. Pain scores will be evaluated with a NRS graded from 0, no pain, to 10, the worst pain imaginable. Measurements for NRS will continue for 72 hours postoperatively. Adjustment of data to a normal distribution will always be verified for the applicability of parametric statistics (Kolmogorov—Smirnov test). Subsequently, the comparison of serial measurement (variables) will performed using one-way analysis of variance (ANOVA) test with Bonferroni correction for multiple comparisons.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/02/2019
Actual
11/02/2019
Date of last participant enrolment
Anticipated
31/12/2021
Actual
Date of last data collection
Anticipated
1/04/2022
Actual
Sample size
Target
120
Accrual to date
22
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 11941 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 24085 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 300776 0
Self funded/Unfunded
Name [1] 300776 0
N/A
Country [1] 300776 0
Primary sponsor type
Hospital
Name
Austin Hospital
Address
145 Studley Rd
Heidelberg, Vic 3084
Country
Australia
Secondary sponsor category [1] 300230 0
None
Name [1] 300230 0
Address [1] 300230 0
Country [1] 300230 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301477 0
Austin Health Human Resarch Ethics Committee
Ethics committee address [1] 301477 0
Ethics committee country [1] 301477 0
Australia
Date submitted for ethics approval [1] 301477 0
03/10/2018
Approval date [1] 301477 0
05/12/2018
Ethics approval number [1] 301477 0

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

Contacts
Principal investigator
Name 87150 0
Dr Brett Pearce
Address 87150 0
Anaesthetic Dept
Austin Hosptial
145 Studley Rd
Heidelberg Vic 3084
Country 87150 0
Australia
Phone 87150 0
+61 402919622
Fax 87150 0
Email 87150 0
[email protected]
Contact person for public queries
Name 87151 0
Brett Pearce
Address 87151 0
Anaesthetic Dept
Austin Hosptial
145 Studley Rd
Heidelberg Vic 3084
Country 87151 0
Australia
Phone 87151 0
+61 402919622
Fax 87151 0
Email 87151 0
[email protected]
Contact person for scientific queries
Name 87152 0
Brett Pearce
Address 87152 0
Anaesthetic Dept
Austin Hosptial
145 Studley Rd
Heidelberg Vic 3084
Country 87152 0
Australia
Phone 87152 0
+61 402919622
Fax 87152 0
Email 87152 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
Currently we have no access to a publicly accessible data repository. The availability of this will depend on which journal we submit to.


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.