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.: PACTR201507001048242 Date of Approval: 25/02/2015
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title postoperative analgesia for knee arthroscopy
Official scientific title Intraarticular Dexmedetomidine with Bupivacaine versus bupivacaine alone for postoperative analgesia after knee arthroscopy
Brief summary describing the background and objectives of the trial Arthroscopic surgery of the knee is a common outpatient procedure. Although intra-articular injection of bupivacaine following arthroscopy has been demonstrated to be safe and effective in providing postoperative analgesia, the mean duration of analgesia is only two hour. Dexmedetomidine (¿2-adrenoceptor agonist) by virtue of its sedative, analgesic, sympatholytic, anesthetic-sparing and hemodynamic stabilizing properties, has been used as an adjunct to local anesthetics for prolongation of effect. This study is designed as randomized controlled trial to evaluate the analgesic efficacy of intra-articular injection of dexmedetomidine added to bupivacaine 0.5% compared to equivalent volume of bupivacaine (0.5%) alone after outpatient knee arthroscopy. We will also assess patient satisfaction from using each drug.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,postopertive analgesia,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/12/2014
Actual trial start date 01/01/2015
Anticipated date of last follow up 30/06/2015
Actual Last follow-up date 10/07/2015
Anticipated target sample size (number of participants) 70
Actual target sample size (number of participants) 70
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
2971/12/14 Research ethics committee,Faculty of medicine, Tanta University
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 Sealed opaque envelopes 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 group 20 ml Bupivacaine 0.5% once intra-articular injection 35 Active-Treatment of Control Group
Experimental Group Dexmedetomidine group 19 ml bupivacaine 0.5 % and 1 ml dexmedetomidine Once Intra-articular injection 35
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
ASA I and II age 18-40 elective knee arthroscopy Patients on chronic use of NSAID,opiates, calcium channel blockers, corticosteroids, tricyclic antidepressant. Patients with psychiatric disorders. History of gastric or duodenal ulcers. Hypersensitivity to NSAIDs, consumption of analgesics within 24 h of surgery. patients with liver or renal disease. Hypersensitivity to local anaesthesia. 18 Year(s) 40 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 31/12/2014 Research ethics committee, Faculty of medicine, Tanta University
Ethics Committee Address
Street address City Postal code Country
Tanta Tanta Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome VAS 30 min 1h 2h 4h 6h 12h 24h both at rest and on knee movement
Secondary Outcome Requirement of rescue analgesia , total pethidine consumption 30 min 1h 2h 4h 6h 12h 24h Both at rest and on knee movement
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of medicine Tanta Geish street Tanta Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Faculty of medicine, Tanta University Tanta Geish street Tanta Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Department of anesthesia and surgical ICU, Tanta University Tanta Geish street Tanta Egypt Hospital
Primary Sponsor Tanta University Tanta Geish street Tanta Egypt University
COLLABORATORS
Name Street address City Postal code Country
Gehan Morsy Eid 7 Tharwat street, Hassan Radwan Tanta Egypt
Mohammed Ali Abdallah 15 Nady street Tanta Egypt
Rehab Saeed Alkalla 21 Stad street Tanta Egypt
Shaimaa Farouk 1 Moheb Street Almahalla Elkobra Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Gehan Morsy Gehan2552011@gmail.com 01287466651 7 Tharwat Street, Hasan Radwan
City Postal code Country Position/Affiliation
Tanta Egypt Lecturer
Role Name Email Phone Street address
Public Enquiries Shaimaa Farouk Shaimaafarouk7777@yahoo.com 01270440771 1 Moheb street
City Postal code Country Position/Affiliation
Almahalla Alkobra Egypt lecturer of aesthesia and surgical ICU
Role Name Email Phone Street address
Scientific Enquiries Mohammed Ali Abdallah moh_aly_2005@hotmail.com 01099957971 15 Nady street
City Postal code Country Position/Affiliation
Tanta Egypt lecturer of anesthesia and ICU
REPORTING
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information