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.: PACTR201604001564996 Date of Approval: 04/04/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Dexmedetomidine and clonidine in ultrasound guided sciatic nerve block
Official scientific title Dexmedetomidine and clonidine as an adjuvant to levobupivacaine in ultrasound guided sciatic nerve block: A randomized, controlled trial
Brief summary describing the background and objectives of the trial This study was done to evaluate the effect of adding dexmedetomidine and clonidine 1µ/kg to levobupivacaine 0.5% with the sciatic nerve block.
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 01/02/2013
Actual trial start date 13/02/2013
Anticipated date of last follow up 04/10/2015
Actual Last follow-up date 08/12/2015
Anticipated target sample size (number of participants) 77
Actual target sample size (number of participants) 60
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 computer software program Sealed opaque envelope Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Levobupivacine Ultrasound guided sciatic nerve block by 20 ml levobupivacaine 0.5% + Ultrasound guided femoral nerve block by 20 ml levobupivacaine 0.5%. once Ultrasound guided sciatic nerve block by 20 ml levobupivacaine 0.5% + Ultrasound guided femoral nerve block by 20 ml levobupivacaine 0.5%. 20 Placebo
Experimental Group Levobupivacaine plud Dexmedetomidine Ultrasound guided sciatic nerve block by 20 ml levobupivacaine 0.5% PLUS dexmedetomidine 1µ/kg+ Ultrasound guided Femoral nerve block by 20 ml levobupivacaine 0.5% PLUS dexmedetomidine 1µ/k Once Ultrasound guided sciatic nerve block by 20 ml levobupivacaine 0.5% PLUS dexmedetomidine 1µ/kg+ Ultrasound guided Femoral nerve block by 20 ml levobupivacaine 0.5% PLUS dexmedetomidine 1µ/k 20
Experimental Group Levobupivacaine plus Clonidine Ultrasound guided sciatic nerve block by 20 ml levobupivacaine 0.5% PLUS clonidine 1µ/kg+ Ultrasound guided Femoral nerve block by 20 ml levobupivacaine 0.5% PLUS clonidine 1µ/kg. Once Ultrasound guided sciatic nerve block by 20 ml levobupivacaine 0.5% PLUS clonidine 1µ/kg+ Ultrasound guided Femoral nerve block by 20 ml levobupivacaine 0.5% PLUS clonidine 1µ/kg. 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Above 18 years old. ASA I, II and III. Undergoing elective lower limb surgery. Coagulation disorders or on anticoagulant therapy. Patients with local skin infection at the side of injection. Patients with psychosis or dementia. Patients with known allergy to one of the used drugs. Patients with neurologic or neuromuscular disorder. Morbid obesity 18 Year(s) 67 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 18/01/2013 Faculty of medicine - Benha University
Ethics Committee Address
Street address City Postal code Country
Farid Nada st Benha 230280 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Duration of sensory block Time interval between complete loss of sensation (by pin prick method in the dermatomal areas corresponding to sciatic nerve) and complete resolution of sensory block.
Secondary Outcome Onset of sensory block Time elapsed between the end of injection and complete loss of sensation
Secondary Outcome Onset of motor block Time elapsed between the end of injection and complete paralysis (absence of dorsiflexion and planter flexion of foot),
Secondary Outcome Duration of motor block Time interval between complete paralysis and complete recovery of motor function.
Secondary Outcome Hemodynamic parameters (Mean arterial blood pressure, heart rate) Recorded at 0, 30, 60, 90, 120 minutes after the block
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Benha faculty of medicine Farid Nada st. Benha 230280 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Benha university Farid Nada st. Benha 230280 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Benha faculty of medicine Farid Nada st. Benha 230280 Egypt University
Secondary Sponsor Benha university Farid Nada st. Benha 230280 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Orthopedic department Benha university hospitals - Farid Nada st Benha 230280 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmed Mostafa Abd El-Hamid bashaahmad@yahoo.com +201005204130 20 Ezz Eldin Omar st.
City Postal code Country Position/Affiliation
Giza 12111 Egypt Assistant professor
Role Name Email Phone Street address
Public Enquiries Saad Ibrahim Saad saadibrahim_7@yahoo.com +201223142889 Oman st.
City Postal code Country Position/Affiliation
Giza Egypt Professor of anesthesia and ICU
Role Name Email Phone Street address
Scientific Enquiries Omar Mohey Eldin Abd Elmaqsoud omarmohy54@hotmail.com +201222170781 Masaken Sheraton
City Postal code Country Position/Affiliation
Cairo Egypt Professor
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