Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201503001053196 Date of Approval: 03/03/2015
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Magnesium Sulphate for postoperative pain management
Official scientific title Intra-articular versus intravenous magnesium-sulphate as adjuvant to femoral nerve block for postoperative analgesia in arthroscopic anterior cruciate ligament reconstruction under general anesthesia: A Randomized controlled trial
Brief summary describing the background and objectives of the trial Background: The combined use of intra-articular (IA) or intravenous (IV) magnesium-sulphate (MgSO4) with femoral nerve block might be associated with additive effects on the duration and quality of postoperative analgesia in arthroscopic knee surgery. Patients and methods: This randomized controlled double-blind study includes 90 patients. Femoral nerve block will be performed in all patients using 20 ml 0.25% bupivacaine before induction of general anesthesia. At the end of surgery patients will be randomly allocated into: Group-IA (intra-articular 1 g MgSO4 in 20ml), Group-IV (intravenous 1 g MgSO4 in 20ml), and Group-P (20 ml intra-articular and 20 ml intravenous normal saline). 20 ml normal saline will be given IV in IA group and IA in IV group. Visual analogue pain score (VAS) at rest, with movement, time to first postoperative rescue analgesia, total postoperative diclofenac consumption, and the number of meperidine rescue doses during the first 24 hours postoperatively will be measured.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Postoperative Pain,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 15/05/2012
Actual trial start date 15/05/2012
Anticipated date of last follow up 15/11/2012
Actual Last follow-up date 15/11/2012
Anticipated target sample size (number of participants) 90
Actual target sample size (number of participants) 90
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Online randomization program (http://www.randomizer.org/) Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Group P 20 ml normal saline/ once 20 ml intra-articular and 20 ml intravenous normal saline 30 Placebo
Experimental Group Group IA intra-articular 1 g MgSO4 in 20m/ once intra-articular 1 g MgSO4 in 20m and 20 ml normal saline IV 30
Experimental Group Group IV intravenous 1 g MgSO4 in 20ml/ once intravenous 1 g MgSO4 in 20ml and 20 ml normal saline IA 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
ASA physical status I and II aging from 18 to 60 years scheduled for arthroscopic ACL reconstruction Patients with hepatic, renal, cardiac, hematological, or respiratory impairment, diabetic patients, morbidly obese, pregnant, patients with history of neuropathy, myopathy and neuromuscular diseases, patients with prior treatment with corticosteroids, calcium channel blockers, opioids patients with cognitive dysfunction that may interfere with the patient ability to provide reliable information about their postoperative pain 18 Year(s) 60 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 14/05/2012 Cairo University, Kasr Al Ainy
Ethics Committee Address
Street address City Postal code Country
Kasr Al Ainy Cairo 11562 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome intensity of postoperative pain at rest as assessed by 0-10 visual analogue pain score (VAS). 2, 4, 6, 12, and 24h postoperative
Secondary Outcome Dynamic visual analogue pain score with movement (knee flexion). 2, 4, 6, 12, and 24h postoperative
Secondary Outcome The period of bearable pain through 24 h postoperative
Secondary Outcome The total postoperative analgesic doses of diclofenac and the number of pethidine rescue doses through 24 h postoperative
Secondary Outcome Side-effects through 24 h postoperative
Secondary Outcome Serum magnesium levels preoperatively and one hour after I.V or intra- articular magnesium sulphate.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Cairo University Hospital (Kasr Al Ainy) Kasr Al Ainy street Cairo 11562 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Cairo University Hospitals Kasr Al Ainy street Cairo 11562 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Cairo University Hospitals Kasr Al Ainy street Cairo 11562 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Shereen Mostafa Maher Amin Palm hills, El Sheikh Zayed, phase 8 6th October 12588 Egypt
Amina Aboul-Ela street 9, Mokattam Cairo 11571 Egypt
Engy Wagdy Megalley Samuel 57 seen, Hadayek Al Ahram Cairo 12572 Egypt
Sarah Mohammed Amin Abdel-Hakim 177 Elharam street Giza 12555 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Abdulatif mohamedabdulatif53@gmail.com +201002550237 Al Saraya street
City Postal code Country Position/Affiliation
Cairo 11562 Egypt Professor of Anaesthesia, Cairo University
Role Name Email Phone Street address
Public Enquiries Sarah Abdel-Hakim sarahamin_22@hotmail.com +201227476617 177 Elharam street
City Postal code Country Position/Affiliation
Giza 12555 Egypt Assistant lecturer of anaesthesia, Cairo University
Role Name Email Phone Street address
Scientific Enquiries Engy Samuel engysamuel@gmail.com +201224448234 57 seen, Hadayek Al Ahram
City Postal code Country Position/Affiliation
Giza 12572 Egypt Lecturer of anaesthesia, Cairo University
REPORTING
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