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.: PACTR202102480485588 Date of Approval: 03/02/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Meperdine Versus Dexmedetomidine as Adjuvants to Lignocaine in Intravenous Regional Anesthesia for below Elbow Orthopaedic Surgeries
Official scientific title Meperdine Versus Dexmedetomidine as Adjuvants to Lignocaine in Intravenous Regional Anesthesia for below Elbow Orthopaedic Surgeries
Brief summary describing the background and objectives of the trial Intravenous regional anesthesia (IVRA) is a safe and reliable method to provide anesthesia for below elbow surgeries.Main disadvantages are tourniquet pain and absence of postoperative analgesia.Many adjuvants have been added to lidocaine to overcome these problems.We designed this study to compare between pethidine and dexmedetomidine when added to lidocaine in IVRA.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/03/2021
Actual trial start date
Anticipated date of last follow up 31/10/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 105
Actual target sample size (number of participants)
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 Simple randomization using by using procedures such as coin-tossing or dice-rolling 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 intravenous regional anesthia lidocaine 3 mg/Kg single dose control group will receive intravenous regional anesthesia with lidocaine 3 mg/Kg 35 Active-Treatment of Control Group
Experimental Group intravenous regional anesthesia lidocaine 3 mg/Kg + pethidine 0.5 mg/Kg single dose experimental group will receive intravenous regional anesthesia with lidocaine 3 mg/Kg + pethidine 0.5 mg/Kg 35
Experimental Group intravenous regional anesthesia lidocaine 3 mg/Kg + dexmedetomidine 0.5 µg/Kg single dose Experimental group will receive intravenous reginal anesthesia with lidocaine 3 mg/Kg + dexmedetomidine 0.5 µg/Kg 35
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Both sex Age: 20-50 years ASA: grade I or II Elective hand and forearm surgeries lasting < 90 min Patients with Raynaud's disease Sickle cell disease History of allergy to the study drugs Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 20 Year(s) 50 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 05/12/2020 Mansoura IRB
Ethics Committee Address
Street address City Postal code Country
Elgomheria St Mansoura 35516 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome tourniquet pain, duration of postoperative analgesia tourniquet pain every 15 minutes
Secondary Outcome intraoperative hemodynamics, SpO2 and degree of sedation every 15 minutes
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mansoura University Hospital El-Gomhoria street Mansoura Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Mohamed Mahmoud Mahdy Mahmoud 44 Eleman St Mansoura Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mansoura University El gomheria St Mansoura Egypt University
Secondary Sponsor Mansoura University Faculty of Medicine Elgomheria St Mansoura Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mohamed Eslam Said Elshehawi Jehan St Mansoura Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Mahmoud Mahdy drmohamed.mahdy@yahoo.com 00201114781275 44 Eleman St,Ahmed Maher St
City Postal code Country Position/Affiliation
Mansoura Egypt Lecturer of Anesthesia and Surgical ICU Faculty of Medicine Mansoura University
Role Name Email Phone Street address
Public Enquiries Mohamed Mahmoud Mahdy drmohamed.mahdy@yahoo.com 00201114781275 44 Eleman St,AhmedMaher St
City Postal code Country Position/Affiliation
Mansoura Egypt Lecturer of Anesthesia and Surgical ICU Faculty of Medicine Mansoura University
Role Name Email Phone Street address
Scientific Enquiries Mohamed Mahmoud Mahdy drmohamed.mahdy@yahoo.com 00201114781275 44Eleman St,Ahmed Maher St
City Postal code Country Position/Affiliation
Mansoura Egypt Lecturer of Anesthesia and Surgical ICU Faculty of Medicine Mansoura University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes I will share study protocol and tables of results within 6 months after finishing the study with any individual or institutional request covered by an appropriate ethical committee Informed Consent Form,Statistical Analysis Plan,Study Protocol Within six months after finishing the study Any communication through an ethical committee or under IRB organization cover
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information