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).

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12616000807459

Acronym

THE AXILLARY TRIAL

Enrollment

109

Registered

2016-06-21

Start date

2010-12-15

Completion date

2016-03-01

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used) (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

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.

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.

Outcome results