Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12617001320347
Ethics application status
Approved
Date submitted
15/06/2017
Date registered
14/09/2017
Date last updated
14/09/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Magnesium in open shoulder surgery
Scientific title
Effect of Intravenous Magnesium on Post-operative Pain following Open Shoulder Surgery
Secondary ID [1] 292177 0
Nil Known
Universal Trial Number (UTN)
U1111-1197-8555
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post-operative Pain 303624 0
Open Shoulder Surgery 303625 0
Condition category
Condition code
Anaesthesiology 303034 303034 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will be administered 50mg/kg of intravenous Magnesium Sulphate at a rate of less than 8g/hr immediately prior to surgery while monitored in the holding bay. This will take place over 30-60 minutes at the anaesthetists discretion. Magnesium sulphate infusion is an established therapy often used in intensive care and the obstetric patient suffering pre-eclampsia. Experience has shown it has a very safe side effect profile. Normal dosage given for previously mentioned indications is 40-50mg/kg. The recommended rate of administration is no greater than 8g per hour. Our regimen is in accordance with these guidelines.
Intervention code [1] 298331 0
Treatment: Drugs
Comparator / control treatment
Intravenous normal saline.
Control group
Placebo

Outcomes
Primary outcome [1] 302408 0
Pain levels as determined by visual analogue pain scale.
Timepoint [1] 302408 0
Outcomes will be measured at 0, 6, 12, 18 and 24 hours.
Secondary outcome [1] 335889 0
Amount of analgesic medications required by review of the patients medical records post discharge and enquiring via telephone communication while at home.
Timepoint [1] 335889 0
At 0, 6, 12, 18 and 24 hours.

Eligibility
Key inclusion criteria
These are patients scheduled for elective open shoulder surgery.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with a chronic pain syndrome, conduction defect or pacemaker, or inability to communicate VAS scoring due to language or miscomprehension will be excluded from this study.

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
25/04/2017
Date of last participant enrolment
Anticipated
1/07/2018
Actual
Date of last data collection
Anticipated
1/07/2018
Actual
Sample size
Target
50
Accrual to date
13
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 8348 0
The Avenue Private Hospital - Windsor
Recruitment postcode(s) [1] 16419 0
3181 - Windsor

Funding & Sponsors
Funding source category [1] 296713 0
Other Collaborative groups
Name [1] 296713 0
Melbourne Orthopaedic Group
Country [1] 296713 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Melbourne Orthopaedic Group
Address
33 The Avenue, Windsor, Victoria
Country
Australia
Secondary sponsor category [1] 295844 0
None
Name [1] 295844 0
Address [1] 295844 0
Country [1] 295844 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297940 0
The Avenue Private Hospital Human Research and Ethics Committee
Ethics committee address [1] 297940 0
40 The Avenue, Windsor, Vic 3181
Ethics committee country [1] 297940 0
Australia
Date submitted for ethics approval [1] 297940 0
06/12/2016
Approval date [1] 297940 0
22/04/2017
Ethics approval number [1] 297940 0
EC00242

Summary
Brief summary
Many patients who require surgery on the shoulder experience significant post operative pain,
particularly after their nerve block wears off. Despite the use of conventional analgesia many patients remain uncomfortable during this period. The aim of this project is to determine whether giving magnesium prior to surgery can improve this pain experience. The study proposes to give a single dose of magnesium to patients immediately prior to surgery and to assess their level of pain after surgery. This will involve the use of a subjective pain rating scale (1-10), and documentation of analgesic requirement. Patients will be randomly selected to receive either magnesium or placebo saline solution in order to assess the benefits of magnesium. Magnesium itself is a safe drug commonly used in clinical medicine for a number of different conditions.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 75526 0
Dr Alexander Morris
Address 75526 0
St Vincent's Hospital Melbourne
41 Victoria Parade, Fitzroy, 3065, VIC
Country 75526 0
Australia
Phone 75526 0
+61402196446
Fax 75526 0
Email 75526 0
[email protected]
Contact person for public queries
Name 75527 0
Dr Alexander Morris
Address 75527 0
St Vincent's Hospital Melbourne
41 Victoria Parade, Fitzroy, 3065, VIC
Country 75527 0
Australia
Phone 75527 0
+61402196446
Fax 75527 0
Email 75527 0
[email protected]
Contact person for scientific queries
Name 75528 0
Dr Alexander Morris
Address 75528 0
St Vincent's Hospital Melbourne
41 Victoria Parade, Fitzroy, 3065, VIC
Country 75528 0
Australia
Phone 75528 0
+61402196446
Fax 75528 0
Email 75528 0
[email protected]

No information has been provided regarding IPD availability


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
No additional documents have been identified.