Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001360707
Ethics application status
Approved
Date submitted
5/12/2013
Date registered
12/12/2013
Date last updated
12/12/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of perioperative intra-articular magnesium on postoperative pain after shoulder surgery
Scientific title
Is perioperative intraarticular magnesium effective for postoperative analgesia in arthroscopic shoulder surgery?
Secondary ID [1] 283704 0
Nil known
Universal Trial Number (UTN)
U1111-1151-0572
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
ASA 1-2 patients scheduled for arthroscopic shoulder surgery by the Orthopaedics Department. 290671 0
Condition category
Condition code
Anaesthesiology 291042 291042 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group M (Magnesium): Patients (n=30) had 1000 mg magnesium sulphate (100 mg ml-1)intraarticular in 10 ml saline

Magnesium administered after completion of the surgery before extubation intraarticularly over 5 minutes.
Intervention code [1] 288398 0
Treatment: Drugs
Comparator / control treatment
Group C (Control): Patients (n=30) had 10 ml saline administered intraarticularly over 5 minutes after completion of the surgery and before extubation
Control group
Placebo

Outcomes
Primary outcome [1] 291030 0
Postoperative pain reduction. Pain assessment done with visual analogue scale.
Timepoint [1] 291030 0
At postoperative 24 hours.
Primary outcome [2] 291031 0
If any decrement present in total diclofenac consumption (It is allowed 2 times diclofenac injection if patient wants) and intraarticular morphine + bupivacaine consumption (with patient controlled analgesia device) in magnesium group when compared to control group.

Diclofenac amount recorded at study protocol paper. Morphine bupivacaine amount recorded study protocol paper by looking at the PCA device.
Timepoint [2] 291031 0
At the end of postoperative 24 hours
Secondary outcome [1] 305865 0
Shoulder pain assessment with visuel analogue scale.
Timepoint [1] 305865 0
At 1,2,6,8,12,18,24 hours after the operation.

Eligibility
Key inclusion criteria
The inclusion criteria were participants are scheduled for arthroscopic shoulder surgery who not to have had any analgesic or corticosteroid for preceeding 72 hours, not to have any drug or alcohol addiction, not to be allergic to study drugs, and be able to use patient controlled analgesia
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria included; known allergy to one of the study drugs; major hepatic, renal, or cardiovascular dysfunction, especially atrioventricular block; and prior treatment with opioids and calcium channel blockers.

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer based randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis
Sample size was estimated using pain scores as the primary variable. It was calculated a group size of 30 patients would be sufficient to detect a difference of 1 cm on the VAS. It was assumed a SD of 1 cm. and at an alpha threshold of 0.007 with 90% power.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/11/2009
Actual
30/11/2009
Date of last participant enrolment
Anticipated
15/10/2010
Actual
16/07/2010
Date of last data collection
Anticipated
Actual
Sample size
Target
70
Accrual to date
Final
Recruitment outside Australia
Country [1] 5666 0
Turkey
State/province [1] 5666 0
KONYA

Funding & Sponsors
Funding source category [1] 288387 0
University
Name [1] 288387 0
Meram Medical School
Country [1] 288387 0
Turkey
Primary sponsor type
University
Name
Meram Medical School
Address
Meram Medical School Akyokus Street 42080 Meram Konya
Country
Turkey
Secondary sponsor category [1] 287088 0
None
Name [1] 287088 0
Address [1] 287088 0
Country [1] 287088 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290273 0
Meram Medical School Ethics Committee
Ethics committee address [1] 290273 0
Meram Medical School Akyokus Street 42080 Meram Konya
Ethics committee country [1] 290273 0
Turkey
Date submitted for ethics approval [1] 290273 0
15/05/2009
Approval date [1] 290273 0
29/05/2009
Ethics approval number [1] 290273 0
2009-249

Summary
Brief summary
Magnesium has analgesic properties, primarily related to the antagonism of the N-methyl-o-aspartate (NMDA) receptor and the regulation of calcium influx into cells . This analgesic effect was first demonstrated in humans in 1996 when magnesium was administered intravenously in the peri-operative period . It has been reported to reduce postoperative analgesic requirements .
The analgesic efficacy of intraarticular magnesium is evident after knee surgery, but its effect after shoulder surgeries has not been reported in the literature . Thus, the goal of this study is to evaluate the potential analgesic effect of magnesium when injected intraarticularly during arthroscopic shoulder surgery.
Trial website
Trial related presentations / publications
This trial preliminary report was presented at VI. International Congress Orthopaedic Anaesthesia and Pain
Public notes

Contacts
Principal investigator
Name 44770 0
Dr Tuba Berra Saritas
Address 44770 0
Meram Medical School Anesthesiology DPT Akyokus Street 42080 Meram Konya
Country 44770 0
Turkey
Phone 44770 0
+905443664244
Fax 44770 0
Email 44770 0
[email protected]
Contact person for public queries
Name 44771 0
Dr Tuba Berra Saritas
Address 44771 0
Meram Medical School Anesthesiology DPT Akyokus Street 42080 Meram Konya
Country 44771 0
Turkey
Phone 44771 0
+905443664244
Fax 44771 0
Email 44771 0
[email protected]
Contact person for scientific queries
Name 44772 0
Dr Tuba Berra Saritas
Address 44772 0
Meram Medical School Anesthesiology DPT Akyokus Street 42080 Meram Konya
Country 44772 0
Turkey
Phone 44772 0
+905443664244
Fax 44772 0
Email 44772 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
SourceTitleYear of PublicationDOI
Dimensions AIIs Intra-Articular Magnesium Effective for Postoperative Analgesia in Arthroscopic Shoulder Surgery?2014https://doi.org/10.1155/2015/648063
N.B. These documents automatically identified may not have been verified by the study sponsor.