ANZCTR - Registration

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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]

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.

Condition category

Condition code

Anaesthesiology

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]

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]

Postoperative pain reduction. Pain assessment done with visual analogue scale.

Timepoint [1]

At postoperative 24 hours.

Primary outcome [2]

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]

At the end of postoperative 24 hours

Secondary outcome [1]

Shoulder pain assessment with visuel analogue scale.

Timepoint [1]

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?

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

Turkey

State/province [1]

KONYA

Funding & Sponsors

Funding source category [1]

University

Name [1]

Meram Medical School

Address [1]

Meram Medical School Akyokus Street 42080 Meram Konya

Country [1]

Turkey

Primary sponsor type

University

Name

Meram Medical School

Address

Meram Medical School Akyokus Street 42080 Meram Konya

Country

Turkey

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Meram Medical School Ethics Committee

Ethics committee address [1]

Meram Medical School Akyokus Street  42080 Meram Konya

Ethics committee country [1]

Turkey

Date submitted for ethics approval [1]

15/05/2009

Approval date [1]

29/05/2009

Ethics approval number [1]

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

Dr Tuba Berra Saritas

Address

Meram Medical School Anesthesiology DPT Akyokus Street 42080 Meram Konya

Country

Turkey

Phone

+905443664244

Fax

tsaritas@konya.edu.tr

Contact person for public queries

Name

Tuba Berra Saritas

Address

Meram Medical School Anesthesiology DPT Akyokus Street 42080 Meram Konya

Country

Turkey

Phone

+905443664244

Fax

tsaritas@konya.edu.tr

Contact person for scientific queries

Name

Tuba Berra Saritas

Address

Meram Medical School Anesthesiology DPT Akyokus Street 42080 Meram Konya

Country

Turkey

Phone

+905443664244

Fax

tsaritas@konya.edu.tr

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

Source	Title	Year of Publication	DOI
Dimensions AI	Is Intra-Articular Magnesium Effective for Postoperative Analgesia in Arthroscopic Shoulder Surgery?	2014	https://doi.org/10.1155/2015/648063

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically