Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00275

2 Trial Registration Date

2010-11-10

i Registration Status

Retrospective

3 Secondary IDs

Nil

4 Source(s) of Funding

Department of Anaesthesia and Intensive Care, CUHK

5 Primary Sponsor

Department of Anaesthesia and Intensive Care, CUHK

6 Secondary Sponsor

nil

Function

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Dr Tsang, Kristie Ho Sze

ii Address

Department of Anaesthesia and Intensive Care, CUHK, Prince of Wales Hospital

iii Phone

26322734

iv Email

kristie@cuhk.edu.hk

v Affiliation

Associate Consultant, Department of Anaesthesia and Intensive Care, Prince of Wales Hospital

vi Country

8 Research Contact Person (person to contact for scientific inquiries)

i Name

Dr Chan, Simon Kin Cheong

ii Address

Department of Anaesthesia and Intensive Care, Prince of Wales Hosiptal

iii Phone

2632 2734

iv Email

simonkcchan@cuhk.edu.hk

v Affiliation

Consultant, Department of Anaesthesia and Intensive Care, Prince of Wales Hospital

vi Country

9 Official Scientific Title of the Study

Analgesic efficacy of intra-articular magnesium after arthroscopic anterior cruciate ligament reconstruction

10 Public Title

Analgesic efficacy of intra-articular magnesium after arthroscopic anterior cruciate ligament reconstruction

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

Nil

12 Countries of Recruitment

Hong Kong

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2008-01-08

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Arthroscopic anterior cruciate ligament reconstruction surgery of knee joint

15 Intervention

i Types of intervention

Drug

Please specify

ii Description/ name of Intervention/article

Intra-articular injection of magnesium for post-operative pain control

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

Once off

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

Placebo control

ii Dosage form of the comparative treatments

iii Dosage of the comparative treatments

iv Duration of the comparative treatments

v Frequency of the comparative treatments

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

Adult patients of ASA I-II and mentally capable for informed consent, who are scheduled for elective arthroscopic ACL reconstruction will be recruited in the study

ii Exclusion Criteria

•ASA III or above
•Impaired renal or liver function
•History of chronic pain or substance abuse
•Known hypersensitivity to sulphur drug or NSAIDs
•Contraindicated for NSAIDs, such as known hypersensitivity, past history of peptic ulcer disease or platelet dysfunction.
•Pregnancy or lactation in female patients
•Contraindications for administration of MgSO4, such as heart block, myocardial damage, myopathy or neurological disorders
•Concomitant medications: digitalis, calcium channel blocker, central nervous system depressants

iii Age Minimum

18 years old

iv Age Maximum

no specific age maximum

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Placebo

iii Degree of masking

Double-blind

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2008-05-01

21 Target Sample Size

42 patient

22 Recruitment Status

Complete

23 Primary Outcome

Pain score at rest. on movement and on weight bearing

24 Secondary Outcome

Sedation, muscle weakness and magnesium level.

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2010-11-10

27 Primary Registry and Trial Identifying Number

ChiCTR-TRC-10001098

28 Date of Registration in Primary Registry

2010-12-01

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

Nil

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Trial History Detail on 2011-02-08