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.: PACTR201411000929541 Date of Approval: 06/11/2014
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Comparative study between intravenous versus epidural lignocaine in ischemia reperfusion injury during total knee arthroplasty
Official scientific title Comparative study between intravenous versus epidural lignocaine in ischemia reperfusion injury during total knee arthroplasty
Brief summary describing the background and objectives of the trial The aim of this work is to compare between intravenous and epidural lignocaine in ischemia reperfusion injury during total knee arthroplasty comparison will be done as regards ischemia reperfusion injury, postoperative pain, quality of early rehabilitation and functional outcome.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Injury, Occupational Diseases, Poisoning,Surgery,Total knee replacement
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 15/10/2013
Actual trial start date 25/10/2013
Anticipated date of last follow up 31/12/2014
Actual Last follow-up date 31/12/2014
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
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
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomisation (block size of 4 and the block size was not variable) Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Intravenous lignocaine 2mg kg lignocine 1% 10 minutes Lignocaine 1% 2mg kg bolus in 10 minutes followed by infusion of 3mg kg hr via a peripheral line and an equal volume of normal saline via an epidural catheter 20
Experimental Group Epidural lignocaine 2mg kg lignocine 1% 10 minutes Lignocaine 1% 2mg kg bolus in 10 minutes followed by infusion of 3 mg kg hr via an epidural line and an equal volume of normal saline through a peripheral intravenous line 20
Control Group Controls 10 minutes Same volume of normal saline infusion via both peripheral intravenous line and the epidural catheter 20 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
elective unilateral total knee arthroplasty due to osteoarithitis -patients using alpha or beta blockers -patients with allergy to other amide local anesthetics - impaired liver functions - chronic use of corticosteroids or non steroidal anti-inflammatory diseases - patients with chronic inflammatory diseases - heart block - antibiotic treatment or inter-current infections -pagets disease -revision arthroplasty 10- cancer 11- vascular disorders 45 Year(s) 70 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 01/10/2013 Ethics Committee, Faculty of Medicine, University of Alexandria
Ethics Committee Address
Street address City Postal code Country
Azarita Aelxandria Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Total leukocyte count Baseline 1 minute before tourniquet release 5,20 minutes after tourniquet release
Primary Outcome Intracellular hydrogen peroxide Baseline 1 minute before tourniquet release 5,20 minutes after tourniquet release
Primary Outcome Soluble intercellular adhesion molecule Baseline 1 minute before tourniquet release 5,20 minutes after tourniquet release
Primary Outcome Von willbrand factor Baseline 1 minute before tourniquet release 5,20 minutes after tourniquet release
Secondary Outcome Assessment of pain 1,6,12,24,48 hours after onset of analgesia
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
El hadara Orthopedics University hospital elhadara Alexandria Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Department of anesthesia and surgical intensive care El azarita Alexandria Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Department of anesthesia and surgical intensive care El azarita Alexandria Egypt University
COLLABORATORS
Name Street address City Postal code Country
Wafaa kamel rady El azarita Alexandria Egypt
Sherif mohammed el hadi El azarita Alexandria Egypt
Shaymaa mohamed ahmed mahmmoud Sidi besher Alexandria Egypt
Hala khodary ahmed Sidi bisher Alexandria Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Wafaa Rady Wafaradi-2@yahoo.com 002-01223106023 El azarita
City Postal code Country Position/Affiliation
Alexandria Egypt Professor of anesthesia and surgical intensive care
Role Name Email Phone Street address
Public Enquiries Elsayedamr Basma elsayedamr@yahoo.com 002-01223106023 30 Garden City Smouha
City Postal code Country Position/Affiliation
Alexandria 21516 Egypt Patient Information Manager
Role Name Email Phone Street address
Scientific Enquiries Sherif Elhadi Selhadi-2006@hotmail.com 002-01223106023 El azarita
City Postal code Country Position/Affiliation
Alexandria Egypt Professor of anesthesia and surgical intensive care
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information