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.: PACTR201503001068335 Date of Approval: 11/03/2015
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of adding dexmeditomidine to epidural bupivacaine
Official scientific title A dose reduction study of local anesthetic with addition of dexmedetomidine on postoperative epidural analgesia for patients undergoing total knee arthroplasty
Brief summary describing the background and objectives of the trial Postoperative pain after total knee arthroplasty is a major interest. Epidural analgesia still the preferred method of postoperative analgesia for total knee arthroplasty in many countries. Dexmedetomidine is a new alpha-2 agonist which had many beneficial effects when administered epidurally. The aim of study was to provide effective postoperative analgesia with hemodynamic stability through reduction of the amount of local anaesthetic administered epidurally by using epidural new adjunct dexmedetomidine.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,knee arthroplasty ,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/01/2012
Actual trial start date 08/01/2012
Anticipated date of last follow up 01/01/2014
Actual Last follow-up date 01/01/2014
Anticipated target sample size (number of participants) 75
Actual target sample size (number of participants) 75
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 simple randomization by computer programe Sealed opaque envelopes Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group bupivacaine 0.125% 5 ml/h 2 days epidural injection 25 Dose Comparison
Experimental Group dexmeditomidine 0.2 microgram/kg/h+ bupivacaine0.125% 4 ml/h 2 days epidural injection 25
Experimental Group dexmeditomidine 0.2 microgram/kg/h+ bupivacaine0.125% 3 ml/h 2 days epidural injection 25
Control Group bupivacaine 0.125% 5 ml/h 48 hours epidural injection 25 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
75 patients, 50¿70 years old, ASA physical status I - III undergoing elective total knee arthroplasty were randomly divided into three equal groups morbid obese, age older than 70 years, known allergy to bupivacaine or dexmedetomidine, renal or hepatic insufficiency, cardiac conduction disturbances, neurological or psychiatric diseases and coagulation disorders 50 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
No 31/03/2015 medical ethical comitte of menofiya facculty of medicine
Ethics Committee Address
Street address City Postal code Country
3, yassin abdelghafar street shibin elkoom 12345 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome volume of local anesthetic 4h 8 12 16 20 24 28 32 36 40 44 48
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
menofiya university hospital 3, yassin abdelghafar street shibin elkoom 12345 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
menofiya university hospital 3, yassin abdelghafar street shibin elkoom 12345 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor menofiya university hospital 3, yassin abdelghafar street shibin elkoom 12345 Egypt University
COLLABORATORS
Name Street address City Postal code Country
ayman ebied 3, yassin abdelghafar street shibin elkoom 12345 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator ashraf eskandr ameskandr@yahoo.com 00201001960697 3, yassin abdelghafar street
City Postal code Country Position/Affiliation
shibin elkoom 12345 Egypt lecturer of anesthesia, icu, menofiya faculty of medicine
Role Name Email Phone Street address
Public Enquiries ayman ebied ayman_ebeid@hotmail.com 00201004262759 3, yassin abdelghafar street
City Postal code Country Position/Affiliation
shibin elkoom 12345 Egypt assistant professor, menofiya faculty of medicine
Role Name Email Phone Street address
Scientific Enquiries ashraf eskandr ameskandr@yahoo.com 00201001960697 3, yassin abdelghafar street
City Postal code Country Position/Affiliation
shibin elkoom 12345 Egypt lecturer of anesthesia, icu, menofiya faculty of medicine
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