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.: PACTR201703002063167 Date of Approval: 26/02/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Postoperative Pain After Knee Arthroscopy
Official scientific title Efficacy of adding dexmedetomidine to intraarticular levobupivacaine on postoperative pain after knee arthroscopy .
Brief summary describing the background and objectives of the trial Post-operative pain is one of the main causes of delayed discharge and rehabilitation. Systemic opioid and nonopioid analgesics, central and peripheral nerve blocks, preemptive analgesia, and intraarticular (IA) drug administration have all been used to prevent or treat pain following arthroscopic knee surgery [1]. Post-operative pain management after arthroscopic knee surgery frequently includes IA local anaesthetic or analgesic agents [2, 3, 4]. Because the duration of analgesia is typically short, the use of combined agents has increased progressively over the past few years [5,6]. Different drugs act in synergy and limit the side effects of a high dose of a single drug [7, 8]. Levobupivacaine, a pure S(-) enantiomer of bupivacaine, is a long-acting local anaesthetic known to have less cytotoxicity and a potentially greater range of safety than racemic bupivacaine [9, 10]. Dexmedetomidine is a potent and highly selective ¿2¿adrenoreceptor agonist. It has sedative-hypnotic, anxiolytic, and analgesic, anaestheticreducing and sympatholytic effects (11). Recently, intra-articular dexmedetomidine has been shown to enhance postoperative analgesia after arthroscopic knee surgery, with an increased time to first analgesic request and a decreased need for postoperative analgesia (12).
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Musculoskeletal Diseases,postoperative pain,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/03/2017
Actual trial start date 01/03/2017
Anticipated date of last follow up 01/03/2017
Actual Last follow-up date 01/06/2017
Anticipated target sample size (number of participants) 90
Actual target sample size (number of participants) 90
Recruitment status Not yet recruiting
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 closed envelop Simple randomisation using a radomisation table created by a computer software program Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group group C 50 ml saline 24 h Received 50 ml saline 30 Active-Treatment of Control Group
Experimental Group group L 50 ml 0.25% levobupivacaine. 24 h Received 50 ml 0.25% levobupivacaine. 30
Experimental Group Group LD 50 ml 0.25% levobupivacaine and dexmedetomidine 1¿g/kg 24 h recieved 50 ml 0.25% levobupivacaine and dexmedetomidine 1¿g/kg 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
ASA physical status I¿II patients, chronic medications intake, relevant drug allergy the need for postoperative intraarticular drainage. 20 Year(s) 35 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 10/04/2016 Mansoura Faculy of medicine
Ethics Committee Address
Street address City Postal code Country
Algomhuria st Mansoura 35516 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Visual Analogue Scale (baseline), and at 30 min, 1h, and then, every hour for 8 hours
Secondary Outcome total meperidine consumption during the first 24 h 24 hour
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mansoura University Hospital Algomhuria street Mansoura 35516 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Mansoura aculty of medicine Algomhuria street Mansoura 35516 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mansoura aculty of medicine Al Gomhuria Mansoura 35516 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mohamed Maher Beder El baz Ahmed Maher st Mansoura Egypt
Tamer el matwally torel Mansoura Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed El baz mmaherelbaz@hotmail.com 00201003729881 1st taksem Khattab
City Postal code Country Position/Affiliation
Mansoura Egypt Lecturer
Role Name Email Phone Street address
Public Enquiries Mohamed El baz mmaherelbaz@hotmail.com 00201003729881 1st taken khattab
City Postal code Country Position/Affiliation
Mansoura Egypt
Role Name Email Phone Street address
Scientific Enquiries Mohamed El baz mmaherelbaz@hotmail.com 00201003729881 1st taken khattab
City Postal code Country Position/Affiliation
Mansoura Egypt
REPORTING
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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