ANZCTR - Registration

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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

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]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Rotator Cuff tear

Labral tear (glenoid labrum)

Shoulder impingement

Condition category

Condition code

Surgery

Other surgery

Anaesthesiology

Anaesthetics

Musculoskeletal

Other muscular and skeletal disorders

Musculoskeletal

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]

Treatment: Other

Intervention code [2]

Treatment: Drugs

Comparator / control treatment

Comparison is to be made between all 3 arms of this project

Control group

Active

Outcomes

Primary outcome [1]

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]

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]

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]

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?

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]

Other

Name [1]

Orthopaedic Research Institute of Queensland

Address [1]

7 Turner Street, Pimlico QLD 4812

Country [1]

Australia

Primary sponsor type

Other

Name

Orthopaedic Research Institute of Queensland

Address

7 Turner Street, Pimlico QLD 4812

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Mater Hospital & Health Services North Queensland Ethics Committee

Ethics committee address [1]

21-37 Fulham Road, Pimlico QLD 4812

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

01/11/2017

Approval date [1]

07/12/2017

Ethics approval number [1]

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

Dr Matthew Wilkinson

Address

Dr Matthew Wilkinson, Orthopaedic Surgeon
1/34 Fulham Road
Pimlico, QLD 4812

Country

Australia

Phone

+61 7 4779 9902

Fax

info@drmattortho.com.au

Contact person for public queries

Name

Andrea Grant

Address

ORIQL House
7 Turner Street, Pimlico
QLD 4812

Country

Australia

Phone

+61 7 4755 0564

Fax

research_coordinator@oriql.com.au

Contact person for scientific queries

Name

Andrea Grant

Address

ORIQL House
7 Turner Street, Pimlico
QLD 4812

Country

Australia

Phone

+61 413685331

Fax

research_coordinator@oriql.com.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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

Source	Title	Year of Publication	DOI
Embase	Efficacy of surgeon-directed suprascapular and axillary nerve blocks in shoulder arthroscopy: a 3-arm prospective randomized controlled trial.	2023	https://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.

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Documents added manually

Documents added automatically