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.: PACTR201605001631245 Date of Approval: 12/05/2016
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Comparison of Magnesium Sulfate and Dexmedetomidine as an Adjuvant to 0.5% Ropivacaine in Infraclavicular Brachial Plexus Block
Official scientific title Comparison of Magnesium Sulfate and Dexmedetomidine as an Adjuvant to 0.5% Ropivacaine in Infraclavicular Brachial Plexus Block
Brief summary describing the background and objectives of the trial Infraclavicular block is safe and effective approach for brachial plexus block that can provides anesthesia for hands, wrist, and forearm (1). Ropivacaine is a propyl analog of bupivacaine ( 2 ). Ropivacaine has the the anesthetic potency and longer duration of action of bupivacaine with less less cardiac and central nervous system toxicity (3). Several adjuvants can be used to prolong the duration of the infraclavicular block as clonidine (4), opioids (5), neostigmine (6), midazolam (7), dexamethasone (6). Magnesium sulfate is a physiological calcium channel blocker and it has also N methyl- D-aspartate (NMDA) receptor antagonist effect ( 8). Thus, it can prevent central sensitization by the peripheral nociceptive simulation. It can be used as adjuvant to local anesthesia for different kinds of regional anesthesia and analgesia to improve the quality and prolong the duration of the block (9). Dexmedetomidine is highly selective ¿2-adrenergic agonist more potent and faster acting than clonidine (10). It has analgesic, sedative, antihypertensive, and anesthetic sparing effects (11). When added to local anesthesia for regional or peripheral nerve block, it prolong the duration of the block and duration of analgesia ( 12,13 ). The aim of our study to evaluate and compare the effect of magnesium sulfate and dexmedetomidine when added to ropivacaine 0.5% in infraclavicular brachial plexus block on the onset and duration of sensory and motor block , the duration of the block and patients satisfaction.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied ,Anaesthesia,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 16/05/2016
Actual trial start date 16/05/2016
Anticipated date of last follow up 01/09/2016
Actual Last follow-up date 23/06/2016
Anticipated target sample size (number of participants) 105
Actual target sample size (number of participants) 105
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 Simplerandomisation using a randomisation table created with a computer software programme 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 Ropivacaine group 35 ml ropivacaine 0.5% and 4 ml normal saline 0.9%. once for infraclavicular block Patients of this group will receive infraclavicular block with 35 ml ropivacaine 0.5% and 4 ml normal saline 0.9%. 35 Placebo
Experimental Group Magnesium sulfate group 150 mg of magnesium sulfate 10% once for infraclavicular block Patients of this group will receive infraclavicular block with 35 ml ropivacaine 0.5% and 150 mg of magnesium sulfate 10% (1.5 ml) with 2.5 ml normal saline 0.9%. 35
Experimental Group Dexmedetomidine group 100¿g dexmedetomidine once for infraclavicular block Patients of this group will receive infraclavicular block with 35 ml ropivacaine 0.5% and 100¿g dexmedetomidine (1 ml) with 3 ml normal saline 0.9%. 35
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
adult patients aged, ASA I-II undergoing elective surgery in hands, wrist and forearm 1- Patient refusal 2- Coagulapathy 3- Renal dysfunction 4- Hepatic dysfunction 5- Patients receiving ¿ adrenergic agonist or antagonist 6- Pregnant ladies 7- Patients with psychiatric or neurological deficit. 18 Year(s) 65 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 16/04/2016 Tanta University, Faculty of Medicine
Ethics Committee Address
Street address City Postal code Country
algiesh Tanta 31512 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome the duration of analgesia at 1h,postoperative 2h, postoperative 4h, postoperative 6h, postoperative 8h, postoperative 12h, postoperative 18h, postoperative 24h postoperative
Secondary Outcome onset and the duration of motor block, will be assessed every 3 minutes in the 1st 30 minutes after injection of local anesthetics and every 30 minutes postoperatively till the infraclavicular block is worn off
Secondary Outcome onset and the duration of sensory block will be assessed every 3 minutes in the 1st 30 minutes after injection of local anesthetics and every 30 minutes postoperatively till the infraclavicular block is worn off
Secondary Outcome consumption of postoperative analgesia 24 h postoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta University Hospitals algeish street Tanta 31512 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
no source of funding
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Tanta University algeish Tanta 31512 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mohamed Mohye Eldin Abu Elyazed algeish street Tanta 31512 Egypt
Ahmed Essam Eldin algeish Tanta 31512 Egypt
Mona Mogahed algeish Tanta 31512 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator mohamed Abu Elyazed mohd_yazed75@yahoo.com +20403462350 algeish street
City Postal code Country Position/Affiliation
Tanta 31512 Egypt lecturer of anesthesiology and surgical intensive care, Tanta university
Role Name Email Phone Street address
Public Enquiries Ahmed Essam Eldin madamada6@gmail.com 00201001802978 algeish street
City Postal code Country Position/Affiliation
Tanta 31512 Egypt lecturer of anesthesiology and surgical intensive care, Tanta university
Role Name Email Phone Street address
Scientific Enquiries mohamed Abu Elyazed mohd_yazed75@yahoo.com +20403462350 algeish street
City Postal code Country Position/Affiliation
Tanta 31512 Egypt lecturer of anesthesiology and surgical intensive care, Tanta university
REPORTING
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