Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000807459
Ethics application status
Approved
Date submitted
6/01/2015
Date registered
21/06/2016
Date last updated
21/06/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Effect of an Axillary Roll During Total Hip Replacement Performed in the Lateral Decubitus Position on Post-operative Shoulder and Neck Pain (The Axillary Trial).
Scientific title
The Effect of an Axillary Roll During Total Hip Replacement Performed in the Lateral Decubitus Position on Post-operative Shoulder and Neck Pain (The Axillary Trial).
Secondary ID [1] 285913 0
nil
Universal Trial Number (UTN)
U1111-1165-7226
Trial acronym
THE AXILLARY TRIAL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post-operative shoulder and neck pain 293839 0
Condition category
Condition code
Anaesthesiology 294140 294140 0 0
Anaesthetics
Musculoskeletal 294569 294569 0 0
Other muscular and skeletal disorders
Surgery 294570 294570 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be placed into the lateral position post induction of anaesthesia. A Standard foam axillary roll is placed under the patient's dependent thorax at the location of the inferior tip of the scapula. A head pillow is to be used in all cases. The axillary roll is to be present for the duration of the surgery and removed at the cessation of anaesthesia. The approximate duration of surgery is 60 minutes.
Intervention code [1] 290895 0
Prevention
Comparator / control treatment
In the non-intervention arm, participants will be placed in the lateral position post induction of anaesthesia without the placement of an axillary roll. A head pillow is to be used in all cases.
Control group
Active

Outcomes
Primary outcome [1] 293939 0
To determine if there is a relationship between the use of an axillary roll during surgery in the lateral decubitus position and the presence or absence of post-operative shoulder and neck pain. In the immediate post-operative phase and on Day One after their operation, participants will be asked what their level of shoulder and neck pain is according to the visual analogue pain scale (VAS).
Timepoint [1] 293939 0
In the immediate post-operative phase and on Day One after their operation, participants will be asked what their level of shoulder and neck pain is according to the visual analogue pain scale (VAS).
Secondary outcome [1] 312199 0
Patients will be asked if they have any tingling or numbness in their hand on the opposite side to their operation (subjective). If the answer is in the affirmative, they will be referred back to their Anaesthetist for follow up, such as nerve studies (objective).
Timepoint [1] 312199 0
In the immediate post-operative phase (in Recovery) and on Day One post- operative phase.

Eligibility
Key inclusion criteria
Inclusion criteria:
1. Patients who will undergo elective total hip replacement surgery at selected sites.
2. Patients over the age of 18
3. Patients in whom informed written consent has been obtained.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria:
1. Patients who have cognitive impairment and who are unable to consent for participation in the trial.
2. Patients who have known brachial plexus pathology on the dependent shoulder prior to the study.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patient selection is according to the operating list. Informed consent is gain from the patient.
The random allocation sequence will be contained within concealed numbered envelopes. The envelopes will look identical, each will have trial identification number and sequential number on it. Inside the envelope will have the intervention allocation and a unique sequential number for the patient. The participants will not known which arm of the study they will be assigned to.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients will be assigned a number through an online random number generator, which will then link them to either arm of the study.
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 2
Type of endpoint/s
Efficacy
Statistical methods / analysis
Patients will be assigned a number through an online random number generator, which will then link them to either arm of the study. The aim is for equal numbers of participants in each arm of the trial. Logistic regression analysis is the chosen method for analysis of data from this trial. The binary factor will be (shoulder and neck) pain or no pain. Participant variables include: sex, age, weight, height and previous shoulder pathology. Procedure variables include general or regional anaesthesia and duration of surgery.
Sample size selection according to Power Calculation:
1. Estimated mean VAS with the use of an axillary roll is greater than or equal to 2
2. Estimated mean VAS without the use of an axillary roll is greater than or equal to 3
3. Standard Deviation: 1.5
4. Sample Size Alpha = 0.05 and B = 0.2
Thus, target sample size = 40 per group (allowing for a 10% drop out rate). Total sample size = 80.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
15/12/2010
Date of last participant enrolment
Anticipated
Actual
1/03/2016
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
109
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 3302 0
Fremantle Hospital and Health Service - Fremantle
Recruitment hospital [2] 3303 0
Rockingham General Hospital - Cooloongup

Funding & Sponsors
Funding source category [1] 290498 0
Hospital
Name [1] 290498 0
Fremantle Hospital
Country [1] 290498 0
Australia
Primary sponsor type
Individual
Name
Dr Ed O'Loughlin
Address
Department of Anaesthesia
Fremantle Hospital
Alma St Fremantle WA 6160
Country
Australia
Secondary sponsor category [1] 289197 0
Individual
Name [1] 289197 0
Dr Gillian Wright
Address [1] 289197 0
Department of Anaesthesia
Mater Health Services
Raymond Terrace
South Brisbane QLD 4101
Country [1] 289197 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292155 0
SOUTH METROPOLITAN AREA HEALTH SERVICE HUMAN RESEARCH ETHICS COMMITTEE
Ethics committee address [1] 292155 0
c/- FREMANTLE HOSPITAL AND HEALTH SERVICE
PO BOX 480 Fremantle
WA 6959
Ethics committee country [1] 292155 0
Australia
Date submitted for ethics approval [1] 292155 0
Approval date [1] 292155 0
01/11/2010
Ethics approval number [1] 292155 0
10/419

Summary
Brief summary
The AXILLARY project aims to explore the relationship between the use of an axillary roll during surgery performed in the lateral decubitus position and the presence or absence of post-operative shoulder and neck pain. The sample population of this trial will be those patients who meet the eligibility criteria and who are to have an elective total hip replacement at selected site. This project is a randomised controlled single-blinded trial where participants will be assigned to the group who receive an axillary roll, or the group that does not. Patients will then be asked to rate their shoulder and neck pain post-operatively on two separate occasions. The results of this project will provide scientific evidence to support or not support the use of an axillary roll during surgery in the lateral decubitus position.
Trial website
N/A
Trial related presentations / publications
Nil
Public notes
Nil further.

Contacts
Principal investigator
Name 53798 0
Dr Gillian Wright
Address 53798 0
Department of Anaesthesia
Royal Brisbane and Women's Hospital
Butterfield Street, Herston
BRISBANE QLD 4029
Country 53798 0
Australia
Phone 53798 0
+61736468111
Fax 53798 0
Email 53798 0
gillianhwright@gmail.com
Contact person for public queries
Name 53799 0
Gillian Wright
Address 53799 0
Department of Anaesthesia
Royal Brisbane and Women's Hospital
Butterfield Street, Herston
BRISBANE QLD 4029
Country 53799 0
Australia
Phone 53799 0
+61736468111
Fax 53799 0
Email 53799 0
gillianhwright@gmail.com
Contact person for scientific queries
Name 53800 0
Gillian Wright
Address 53800 0
Department of Anaesthesia
Royal Brisbane and Women's Hospital
Butterfield Street, Herston
BRISBANE QLD 4029
Country 53800 0
Australia
Phone 53800 0
+61736468111
Fax 53800 0
Email 53800 0
gillianhwright@gmail.com

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What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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