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
Ethics application status
Date submitted
Date registered
Date last updated
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)
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

Study type
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

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.

Key inclusion criteria
These are patients scheduled for elective open shoulder surgery.
Minimum age
18 Years
Maximum age
75 Years
Both males and females
Can healthy volunteers participate?
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
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
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
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
Address [1] 296713 0
33 The Avenue, Windsor, Victoria, 3181
Country [1] 296713 0
Primary sponsor type
Other Collaborative groups
Melbourne Orthopaedic Group
33 The Avenue, Windsor, Victoria
Secondary sponsor category [1] 295844 0
Name [1] 295844 0
Address [1] 295844 0
Country [1] 295844 0

Ethics approval
Ethics application status
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
Date submitted for ethics approval [1] 297940 0
Approval date [1] 297940 0
Ethics approval number [1] 297940 0

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

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
Phone 75526 0
Fax 75526 0
Email 75526 0
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
Phone 75527 0
Fax 75527 0
Email 75527 0
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
Phone 75528 0
Fax 75528 0
Email 75528 0

No information has been provided regarding IPD availability
Summary results
No Results