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.: PACTR201407000850309 Date of Approval: 08/07/2014
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title postoperative analgesia following total knee arthroplasty
Official scientific title Effect of dexamethasone added to bupivacaine for femoral nerve block on the quality of postoperative analgesia following total knee arthroplasty: A randomized, double blinded, controlled study.
Brief summary describing the background and objectives of the trial Effect of dexamethasone added to bupivacaine for femoral nerve block on the quality of postoperative analgesia following total knee arthroplasty: A randomized, double blinded, controlled study. Achieving adequate analgesia after total knee arthroplasty (TKA) can be a challenging; femoral nerve block (FNB) has been investigated and found to improve pain control following total knee arthroplasty (TKA). Mixing local anesthetic with adjuvant drugs improve the quality of analgesia from peripheral nerve blocks. We hypothesized that; adding dexamesathone to bupivacaine for continuous femoral nerve block provides better pier-operative analgesia than standard CFNB
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Orthopaedics,postoperative pain,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 28/08/2014
Actual trial start date 28/08/2014
Anticipated date of last follow up 03/03/2015
Actual Last follow-up date 04/03/2015
Anticipated target sample size (number of participants) 200
Actual target sample size (number of participants)
Recruitment status Completed
Publication URL http://onlinelibrary.wiley.com/doi/10.1111/aas.12750/pdf
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 randomization will be generated research randomizer computer generated programme central randomization using the phone calls to anethesia technician who is not partcipating in outcome assessment he will prepare the injection solution and give them a unique code Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group bupivacaine 0.5 % 25 ml loading 0.25 % bupivacaine 4 m/h for 72 h continous femoral nerve block 100 Active-Treatment of Control Group
Experimental Group 0.5% bupivacaine plus dexamethasone 0.5% bupivacaine 25 ml plus 8 mg dexamethasone infusion of 0.25% bupivacaine 4ml/h for 72 h continous femoral nerve block 100
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1- patients having osteoarthritis 2- age above 50 3- ASA 1,2,3 patients 4-both sexes contraindication to peripheral nerve block (femoral nerve block),ASA IV or V, peripheral neuropathy, acute intercurrent heart disease; chronic opiate use, and known allergic reaction to local an aesthetics, paracetamol or morphine; skin lesions/infection at block site; renal dysfunction, and Patients with systemic infections 50 Year(s) 80 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 02/06/2014 Menoufia university hospitals,ethics committee for clinical research
Ethics Committee Address
Street address City Postal code Country
Gamal abdel-nasser street, Shebin Elkom,Menoufia Egypt Shebin Elkom NA Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome time to the first analgesia required for pain at the surgical sight the first recorded time when patient feels pain
Primary Outcome the amount of morphine required in the first 24 hours and comparing the total amount of morphine used in the two studied groups at 24 hour postoperatively
Secondary Outcome numerical rating pain score (NRS) from 0 (no pain) to 10 (worst pain imaginable) both at rest and on flexion of the operated knee 1, 2, 4, 6, 12, 24, 48, and 72 h postoperatively
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Menoufiya university Gamal abdel-nasser street Shebin Elkom, Menoufia NA Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Menofia University Gamal abdel-nasser street Shebin Elkom, Menoufia NA Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Menofia University Gamal abdel-nasser street Shebin Elkom, Menoufia NA Egypt University
COLLABORATORS
Name Street address City Postal code Country
Hazem Elsersy 89 saad Zagloul street Shebin Elkom, Menoufia NA Egypt
Abeer sherif Alshatby Alexandria NA Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator abeer shreif dr.abeersherif@hotmail.com 0096565129328 alshatby
City Postal code Country Position/Affiliation
Alexandria NA Egypt assistent professor of anethesia, menoufia university
Role Name Email Phone Street address
Public Enquiries Hazem Elsersy hazelsersy@hotmail.com 00201222598999 89 Saad Zagloul street
City Postal code Country Position/Affiliation
Shebin Elkom NA Egypt Lecturer of Anethesia, Faculty of medicine,Menoufia University
Role Name Email Phone Street address
Scientific Enquiries Hazem Elsersy hazelsersy@hotmail.com 00201222598999 89 Saad Zagloul street
City Postal code Country Position/Affiliation
Shebin Elkom NA Egypt Lecturer of Anethesia, Faculty of medicine,Menoufia University
REPORTING
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