Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001546347
Ethics application status
Approved
Date submitted
30/10/2017
Date registered
9/11/2017
Date last updated
16/07/2021
Date data sharing statement initially provided
6/02/2020
Date results information initially provided
16/07/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Regional Anaesthesia in Shoulder Arthroscopy: A comparative study
Scientific title
A comparison of efficacy of three techniques for regional anaesthesia in patients undergoing shoulder arthroscopy.
Secondary ID [1] 293239 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rotator Cuff tear 305285 0
Labral tear (glenoid labrum) 305286 0
Shoulder impingement 305287 0
Condition category
Condition code
Surgery 304593 304593 0 0
Other surgery
Anaesthesiology 304614 304614 0 0
Anaesthetics
Musculoskeletal 304652 304652 0 0
Other muscular and skeletal disorders
Musculoskeletal 314431 314431 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1 - Interscalene nerve block [brachial plexus block] (ISB), inserted under ultrasound-guidance by a consultant anaesthetist.
- Ropivacaine 100mg + Clonidine, 75mcg, made up to 20mL with 0.9% saline
- Single dose, prior to surgery.
- Adherence not applicable, blocks inserted after the patient is under GA
Arm 2 - Suprascapular Nerve Block + Axillary Nerve Block (SSNB+ANB), inserted under ultrasound-guidance by a consultant anaesthetist.
- Ropivacaine 100mg + Clonidine, 75mcg, made up to 20mL with 0.9% saline
- Single dose, prior to surgery. 10mL per nerve.
- Adherence not applicable, blocks inserted after the patient is under GA
Arm 3 - Suprascapular Nerve Block + Axillary Nerve Block (SSNB+ANB), inserted by arthroscopic guidance by a consultant orthpaedic surgeon.
- Ropivacaine 100mg + Clonidine, 75mcg, made up to 20mL 0.9% saline
- Single dose, during surgery, 10mL per nerve
- Adherence not applicable, blocks inserted after the patient is under GA
Intervention code [1] 299498 0
Treatment: Other
Intervention code [2] 299543 0
Treatment: Drugs
Comparator / control treatment
Comparison is to be made between all 3 arms of this project
Control group
Active

Outcomes
Primary outcome [1] 303817 0
Efficacy of pain management in the perioperative period, as assessed by pain scores (obtained through use of visual analogue scale) and records of analgesic requirement/administration. [Composite means of determining primary outcome - efficacy of pain management - continuous outcome]
Timepoint [1] 303817 0
Immediate post-operative period (while participant is in Post-anaesthetic recovery unit). VAS score will be taken at two timepoints in PACU:
1. When participant is sufficiently awake to complete the score (initial pain score)
2. Upon discharge from first-stage PACU (generally 30-60min after arrival)
Secondary outcome [1] 340219 0
Patient satisfaction with their experience, assessed through use of a questionnaire.
The questionnaire is an adapted version of that used for evaluation of patient satisfaction with regional anaesthesia by Montenegro et al (2006). It has been translated from the original French and adapted to better suit the design of this project.
Timepoint [1] 340219 0
1 week post-operatively.

Eligibility
Key inclusion criteria
Patients scheduled to undergo shoulder arthroscopy under the care of the investigating surgeons.
Male and female
Age 18-90
Able to provide informed consent
Patients with BMI <40
Patients not currently taking regular opioid analgesics
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with distorted anatomy that may negatively impact on block insertion
Patients with pre-existing nerve injury/neuropathy affecting the innervation of the upper limb & shoulder.
Patients with a known adverse drug reaction to the medications used in this study
Patients with comorbid medical conditions that would contraindicate block insertion (i.e. ISB in severe COPD)
Patients unable to comply with assessment requirements
Patients with active infection
Patients with BMI >40
Patients who are pregnant or planning on becoming pregnant during the course of the study
Patients unable to provide informed consent

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
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation through use of computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis
Assuming Type I error (alpha) to 5% (p = 0.05) and Type II error (beta) to 0.2 (power equal to 80%), the sample size calculated to be able to observe differences in block efficacy was 35 participants per study group; a total of 105 study participants.
To compensate for 10% expected loss to follow-up, 40 participants will be recruited to each of the study groups; a total of 120 patients.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/11/2017
Actual
1/08/2018
Date of last participant enrolment
Anticipated
1/08/2020
Actual
13/11/2020
Date of last data collection
Anticipated
1/01/2021
Actual
13/11/2020
Sample size
Target
120
Accrual to date
Final
130
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 297868 0
Other
Name [1] 297868 0
Orthopaedic Research Institute of Queensland
Country [1] 297868 0
Australia
Primary sponsor type
Other
Name
Orthopaedic Research Institute of Queensland
Address
7 Turner Street, Pimlico QLD 4812
Country
Australia
Secondary sponsor category [1] 296914 0
None
Name [1] 296914 0
Address [1] 296914 0
Country [1] 296914 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298919 0
Mater Hospital & Health Services North Queensland Ethics Committee
Ethics committee address [1] 298919 0
21-37 Fulham Road, Pimlico QLD 4812
Ethics committee country [1] 298919 0
Australia
Date submitted for ethics approval [1] 298919 0
01/11/2017
Approval date [1] 298919 0
07/12/2017
Ethics approval number [1] 298919 0
MHS20171114-01

Summary
Brief summary
This study aims to compare the efficacy of three methods of regional anaesthesia in shoulder arthroscopy, as well as to compare patient satisfaction with the three methods. People undergoing shoulder arthroscopy will be invited to take part in the trial and will be randomised to one of three groups if they accept.
The three groups comprise an Interscalene block, inserted by an anaesthetist; a combined suprascapular & axillary nerve block inserted by an anaesthetist;and the combined block inserted by the treating surgeon during the procedure.
Outcomes examined by this study include pain levels after the operation (in the recovery room, the next day & out to a week later), how much pain relieving medication was used and how satisfied the participants were with their experience of regional anaesthesia (through use of a survey form).
The findings of this study will be utilised to guide clinical practice in the use of regional anaesthesia in arthroscopic shoulder procedures.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 78646 0
Dr Matthew Wilkinson
Address 78646 0
Dr Matthew Wilkinson, Orthopaedic Surgeon
1/34 Fulham Road
Pimlico, QLD 4812
Country 78646 0
Australia
Phone 78646 0
+61 7 4779 9902
Fax 78646 0
Email 78646 0
info@drmattortho.com.au
Contact person for public queries
Name 78647 0
Mrs Andrea Grant
Address 78647 0
ORIQL House
7 Turner Street, Pimlico
QLD 4812
Country 78647 0
Australia
Phone 78647 0
+61 7 4755 0564
Fax 78647 0
Email 78647 0
research_coordinator@oriql.com.au
Contact person for scientific queries
Name 78648 0
Mrs Andrea Grant
Address 78648 0
ORIQL House
7 Turner Street, Pimlico
QLD 4812
Country 78648 0
Australia
Phone 78648 0
+61 413685331
Fax 78648 0
Email 78648 0
research_coordinator@oriql.com.au

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


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
SourceTitleYear of PublicationDOI
EmbaseEfficacy of surgeon-directed suprascapular and axillary nerve blocks in shoulder arthroscopy: a 3-arm prospective randomized controlled trial.2023https://dx.doi.org/10.1016/j.jseint.2022.12.011
N.B. These documents automatically identified may not have been verified by the study sponsor.