Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000873123
Ethics application status
Approved
Date submitted
6/06/2019
Date registered
19/06/2019
Date last updated
19/06/2019
Date data sharing statement initially provided
19/06/2019
Date results provided
19/06/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised trial comparing Adductor Canal plus Obturator Posterior nerve blocks to Femoral nerve block for Arthroscopic Anterior Cruciate Ligament reconstruction
Scientific title
A randomised trial comparing Adductor Canal plus Obturator Posterior nerve blocks to Femoral nerve block for Arthroscopic Anterior Cruciate Ligament reconstruction
Secondary ID [1] 298441 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anterior cruciate ligament reconstruction 313175 0
Condition category
Condition code
Anaesthesiology 311635 311635 0 0
Pain management
Surgery 311759 311759 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Adductor canal plus obturator posterior nerve blocks as part of anaesthetic for arthroscopic anterior cruciate ligament reconstruction. Adductor canal block performed using 7.5ml of 0.75% ropivicaine. Obturator posterior nerve block performed using 7.5ml of 0.75% ropivicaine, and performed at the same time as the adductor canal block. Both injections were single dose perineural injections via a 21-G, 100 mm long SonoPlex needle, and performed with ultrasound guidance (Sono-Site M-Turbo ultrasound unit) in an operating theatre during monitored anaesthetic care prior to the start of surgery. Examination of fidelity to the intervention undertaken via examination of the anaesthetic record (scanned paper copy available on electronic patient health record).
Intervention code [1] 314685 0
Treatment: Drugs
Intervention code [2] 314785 0
Treatment: Other
Comparator / control treatment
Femoral nerve block as part of anaesthetic for arthroscopic anterior cruciate ligament reconstruction. Femoral nerve block performed performed using 7.5ml of 0.75% ropivicaine. Nerve block performed with ultrasound guidance in operating theatre during monitored anaesthetic care. Ultrasound and needle as above
Control group
Active

Outcomes
Primary outcome [1] 320336 0
Pain, measured in terms of opioid consumption (oxycodone equivalence in 24 hour peri-operative period). Opioid consumption was obtained from the patients' electronic health record for the hospital-stay portion of the first 24 hours, and also obtained via a telephone call to the patient, performed by a study investigator who was blinded as to the intervention (as was the patient).
Timepoint [1] 320336 0
At two points: in the post-anaesthetic care unit, where length of stay was up to three hours. The second time point was after discharge from the post-anaesthetic care unit, but up to 24 hours after surgery. This was obtained via a telephone call to the patient, performed by a study investigator who was blinded as to the intervention (as was the patient).
Primary outcome [2] 320440 0
Pain, measured via pain score (11 point, numeric, self-assessed scale).
Timepoint [2] 320440 0
At two points: in the post-anaesthetic care unit, where multiple measures are taken prior to discharge. The maximum reported pain score was recorded. Length of stay was up to three hours. The second time point was after discharge from the post-anaesthetic care unit, but up to 24 hours after surgery. This was obtained via a telephone call to the patient, performed by a study investigator who was blinded as to the intervention (as was the patient).
Secondary outcome [1] 371271 0
Quadriceps strength, measured according to on the 6 point Medical Research Council Manual Muscle Testing system
Timepoint [1] 371271 0
In post-anesthetic care unit (typically the first three hours after surgery), with nursing staff assessing using the scale given above, plus obtained via a telephone call to the patient performed 24 to 48 hours after surgery, performed by a study investigator who was blinded as to the intervention (as was the patient). Patients were reminded of the scale used, and asked to report the weakest rating.
Secondary outcome [2] 371272 0
Nausea and/or vomiting in the first 24 hours post surgery, measured according to a four-point scale. Assessed by nursing staff in post-anaesthetic care unit, and self-reported post discharge.
Timepoint [2] 371272 0
In post-anesthetic care unit (typically the first three hours after surgery), with nursing staff assessing, plus obtained via a telephone call to the patient performed 24 to 48 hours after surgery, performed by a study investigator who was blinded as to the intervention (as was the patient). Patients were reminded of the scale used, and asked to report the weakest rating.
Secondary outcome [3] 371273 0
Sedation in the first 24 hours post surgery, according to assessment by nursing staff in post-anaesthetic care unit, and self-reported post discharge.
Timepoint [3] 371273 0
In post-anesthetic care unit (typically the first three hours after surgery), with nursing staff assessing, plus obtained via a telephone call to the patient performed 24 to 48 hours after surgery, performed by a study investigator who was blinded as to the intervention (as was the patient). Patients were reminded of the scale used, and asked to report the weakest rating.

Eligibility
Key inclusion criteria
Patients 16 years of age and older scheduled to undergo arthroscopic anterior cruciate ligament reconstruction at one of two hospitals in our health network.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who refused consent, had an allergy to local anesthetic drugs, had a contraindication to regional anesthesia, or had a history of treatment for a chronic pain disorder.

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)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients were randomly assigned to a treatment group via random block allocation using an Excel spreadsheet
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
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Sample size was based on a formal a priori power analysis using G*Power 3.1 (Heinrish Heine Universität Düsseldorf) based upon a retrospective audit of ACL repair opioid consumption (oxycodone equivalence during first 24 hours) involving 24 patients. Required sample size was computed using t test, difference between two independent means, two tails, alpha error of 0.05, and power (1 – beta error) of 0.90. This resulted in a minimum sample size of 24 in each group. To allow for patient withdrawals and block failures, we decided to use 30 patients in each group for a total of 60 patients.

Statistical analyses were performed using R 3.5.1 (R Core Team (2018). R: A language and environment for statistical computing. R Foundation for Statistical Computing, Vienna, Austria. https://www.R-project.org/). Summaries statistics were presented by treatment group; means and standard deviations (SD) for normally distributed data and medians and Interquartile ranges (IQR) were reported for non-normally distributed data. Normality was assessed using the absolute value of skewness or kurtosis greater than 2. Statistically significant differences between treatment groups were examined using a t-test for normally distributed data and Mann-Whitney test for ‘non-normal’ data. Statistically significant treatment relationships were examined further by using multiple regression models accounting for other covariates (such as nausea, vomiting, pain score, sedation score and oxycodone equivalence). Regression model residuals were assessed using the Shapiro-Wilk normality test.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
24/10/2016
Date of last participant enrolment
Anticipated
Actual
7/08/2018
Date of last data collection
Anticipated
Actual
8/08/2018
Sample size
Target
60
Accrual to date
Final
61
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 13962 0
Repatriation General Hospital - Daw Park
Recruitment hospital [2] 13963 0
Noarlunga Health Service - Noarlunga Centre
Recruitment postcode(s) [1] 26732 0
5041 - Daw Park
Recruitment postcode(s) [2] 26733 0
5168 - Noarlunga Centre

Funding & Sponsors
Funding source category [1] 302987 0
University
Name [1] 302987 0
Flinders University
Country [1] 302987 0
Australia
Primary sponsor type
Individual
Name
Perry Fabian
Address
Department of Anaesthesia
Flinders Medical Centre
Bedford Park SA 5042
Country
Australia
Secondary sponsor category [1] 302945 0
None
Name [1] 302945 0
Address [1] 302945 0
Country [1] 302945 0
Other collaborator category [1] 280731 0
Individual
Name [1] 280731 0
Shannon Sim
Address [1] 280731 0
Department of Orthopaedics
Flinders Medical Centre
Bedford Park SA 5042
Country [1] 280731 0
Australia
Other collaborator category [2] 280732 0
Individual
Name [2] 280732 0
Jason Koerber
Address [2] 280732 0
Department of Anaesthesia
Flinders Medical Centre
Bedford Park SA 5042
Country [2] 280732 0
Australia
Other collaborator category [3] 280733 0
Individual
Name [3] 280733 0
Vijeyadezmi Ganasan
Address [3] 280733 0
Flinders University
Sturt Road
Bedford Park SA 5042
Country [3] 280733 0
Australia
Other collaborator category [4] 280734 0
Individual
Name [4] 280734 0
Bradley Harvey
Address [4] 280734 0
Flinders University
Sturt Road
Bedford Park SA 5042
Country [4] 280734 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303538 0
Southern Area Clinical Human Research Ethics Committee
Ethics committee address [1] 303538 0
Ethics committee country [1] 303538 0
Australia
Date submitted for ethics approval [1] 303538 0
18/01/2016
Approval date [1] 303538 0
06/04/2016
Ethics approval number [1] 303538 0
OFR # 001.16 - HREC/16/SAC/14

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

Contacts
Principal investigator
Name 94010 0
Dr Perry Fabian
Address 94010 0
Department of Anaesthesia
Flinders Medical Centre
Bedford Park SA 5042
Country 94010 0
Australia
Phone 94010 0
+61 415431046
Fax 94010 0
Email 94010 0
[email protected]
Contact person for public queries
Name 94011 0
Perry Fabian
Address 94011 0
Department of Anaesthesia
Flinders Medical Centre
Bedford Park SA 5042
Country 94011 0
Australia
Phone 94011 0
+61 415431046
Fax 94011 0
Email 94011 0
[email protected]
Contact person for scientific queries
Name 94012 0
Perry Fabian
Address 94012 0
Department of Anaesthesia
Flinders Medical Centre
Bedford Park SA 5042
Country 94012 0
Australia
Phone 94012 0
+61 415431046
Fax 94012 0
Email 94012 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)?
Immediately following publication, no end date
Available to whom?
Only researchers who provide a methodologically sound proposal
Available for what types of analyses?
Only to achieve the aims in the approved proposal
How or where can data be obtained?
Access subject to approvals by Principal Investigator, with a requirement to sign data access agreement


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
2276Informed consent form    377738-(Uploaded-06-06-2019-15-06-51)-Study-related document.pdf
2277Ethical approval    377738-(Uploaded-06-06-2019-15-07-08)-Study-related document.pdf



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.