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.: PACTR201711002712946 Date of Approval: 21/10/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Diltiazem added to local anesthetic in sonar guided infra-clavicular brachial plexus block.
Official scientific title The analgesic and dose sparing effect of diltiazem added to local anesthetic in sonar guided infraclavicular brachial plexus block.
Brief summary describing the background and objectives of the trial Additives to local anesthetics aim at improving the quality of the block and increase the postoperative analgesia. Calacium channel blockers can have an antinociceptive effects when added to local anesthetics. Aim and Objectives: This randomized, prospective double blind study will be performed to evaluate the efficacy of diltiazem added to local anesthetic during sonar guided infraclavicular coracoid brachial plexus block . This evaluation will be as regard to its analgesic effect and wheather it can decrease the total dose of local anesthetic required to have adequate block .
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Local Anesthesia - sonar guided infraclavicular brachial plexus block
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 26/10/2017
Actual trial start date 30/12/2017
Anticipated date of last follow up 31/12/2017
Actual Last follow-up date 31/12/2017
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 simple randomisation using a randomisation table created by a computer software program 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 sonar guided infraclavicular brachial plexus block using mixture of local anesthetics 30 ml solution containing 14 ml 2% lignocaine ,14 ml 0,5% bupivacaine and 2 ml saline 80 minutes sonar guided infraclavicular block using local anesthetic through the coracoid approach 30 Active-Treatment of Control Group
Experimental Group sonar guided brachial plexus block using mixture of local anesthetics plus 20 mg diltiazem 30 ml solution containing 14 ml 2% lignocaine ,14 ml 0,5% bupivacaine and 2 ml saline containing 20 mg diltiazem 80 minutes sonar guided infraclavicular block using local anesthetic plus 20 mg diltiazem through the coracoid approach 30
Experimental Group sonar guided infraclavicular block using low dose local anesthetic plus 20 mg diltiazem 30 ml solution containing 10 ml 2% lignocaine ,10 ml 0,5% bupivacaine and 10 ml salinecontaining 20 mg diltiazem 80 minutes sonar guided infraclavicular block using low dose local anesthetic plus 20 mg diltiazem through the coracoid approach 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- 90 patients, aged 18-70 years -with American Society of Anesthesiologists¿ status I- II -scheduled for forearrn and hand surgery were included . - patients with significant coagulopathy, -allergy to local anesthetic or study drug , -local skin infection. - known neuropathies, -history of conductive heart disease . 18 Year(s) 70 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 16/03/2016 tanta university faculty of medicine Research ethical committee
Ethics Committee Address
Street address City Postal code Country
algeish Tanta 31150 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome duration of analgesia Visual analogue scale will be measured 1, -2, -4 -6 - 12 hours postoperatively
Secondary Outcome onset of sensory and motor block, visual analogue scale, analgesic consumption, block-related complications and the ability of diltiazem to reduce the dose of local anesthetic sufficient to produce adequate block. -every 5 minutes for 30 minutes for onset of sensory and motor block - every 1,2,4,6 and 12 hours for VAS. - Every 30 minutes till complete recovery of sensory and motor blocks. -the duration of analgesia(time between onset of action and onset of pain) , the total dose of analgesia consumed in the first 24 hours.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Anesthesia and Surgical Intensive care department,Faculty of Medicine,Tanta University, Tant, Egypt elgeish Tanta 31150 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
tanta university hospitals Algeish Tanta 31150 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor tanta university hospital <anesthesia and surgical intensive care department Algeish Tanta 31150 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Ashraf Elsayed Alzeftawy Shober street Tanta 31150 Egypt
Hesham Elsayed Elsheikh Kohafa bridge Tanta 31152 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ashraf Alzeftawy ashrafz633@yahoo.com 00201223713667 shober street
City Postal code Country Position/Affiliation
Tanta 31150 Egypt Assistant Professor of Anesthesia and Surgical Intensive care, Faculty of Medicine,Tanta University
Role Name Email Phone Street address
Principal Investigator Hesham Elsheikh hesham330@yahoo.com 01009949312 Kohafa bridge
City Postal code Country Position/Affiliation
Tanta 31152 Egypt Assistant Professor of Anesthesia and Surgical Intensive care, Faculty of Medicine,Tanta University
Role Name Email Phone Street address
Public Enquiries Hesham Elsheikh hesham330@yahoo.com 01009949312 Kohafa Bridge
City Postal code Country Position/Affiliation
Tanta 31152 Egypt Assistatnt Professor Anesthesia and Surgical Intensive Care, Faculty of Medicine, Tant Univ, Egypt
Role Name Email Phone Street address
Scientific Enquiries Ashraf Alzeftawy ashrafz633@yahoo.com 00201223713667 Shober street
City Postal code Country Position/Affiliation
Tanta 30150 Egypt assistant prodessor of anesthesia and surgical intensive care ,faculty of medicine ,Tanta university
REPORTING
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