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.: PACTR201510001297568 Date of Approval: 07/10/2015
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Dexamethasone added to levobupivacaine prolongs interscalene brachial plexus blockade
Official scientific title Dexamethasone added to levobupivacaine prolongs ultrasound guided interscalene brachial plexus blockade: A prospective, randomized, controlled study
Brief summary describing the background and objectives of the trial Background:Various adjuvants have been used to prolong the block duration of local anesthetic.Corticosteroid adjuvants have been found to prolong the block duration when added to local anesthetics Objectives: This study aimed to evaluate the effect of the addition of dexamethasone to levobupivacaine on the duration of analgesia in forearm surgeries under ultrasound guided inter scalene (ISB) brachial plexus block.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,interscalene brachial plexus blockade,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 07/09/2014
Actual trial start date 24/09/2014
Anticipated date of last follow up 01/04/2015
Actual Last follow-up date 16/04/2015
Anticipated target sample size (number of participants) 75
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 generated randomization program Sealed envelopes containing group allocation were opened before the blocks were performed 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 Group L 25 ml of 0.5% levobupivacaine plus 2 ml of normal saline 0.9% inter scalene (ISB) brachial plexus block 30 Placebo
Experimental Group Group LD 25 ml of 0.5% levobupivacaine plus 2 ml of dexamethasone (8 mg) inter scalene (ISB) brachial plexus block 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
ASA I & II their ages ranged between 18 and 65 years who had elective forearm surgeries under ultrasound guided inter scalene (ISB) brachial plexus block. patients refusal, known allergy to the local anesthetic, coagulopathy, local infection, patients with peripheral neuropathy, uncooperative patients patients with body mass index >35kg/m2. 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 03/09/2014 Benha faculty of medicine
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 the sensory block was taken from the time of maximum sensory block till VAS become ¿ 4
Secondary Outcome Onset of the sensory block was taken from the time of the end of ISB procedure till complete loss of sensation by pin prick test
Secondary Outcome Duration of the motor blockade was taken from the time of the end of ISB procedure till no motor weakness could be detected
Secondary Outcome Time to first analgesic request was taken from the time of maximum sensory block till the patient's first analgesic request
Secondary Outcome Number of failed block Block was considered failed when sensory anesthesia was not achieved within 30 minutes.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Benha university Farid Nada st. Benha 230280 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
benha faculty of medicine 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
COLLABORATORS
Name Street address City Postal code Country
Mohamed A. Alrabiey Kafr Elgazzar, Benha Benha Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmed Mostafa Abd El-Hamid bashaahmad@yahoo.com 00201005204130 20 Ezz Eldin Omar st
City Postal code Country Position/Affiliation
Giza 12111 Egypt Assistant professor
Role Name Email Phone Street address
Public Enquiries Mohamed Alrabiey ashrafrabiey111@gmail.com 00201144244462 Kafr Elgazzar
City Postal code Country Position/Affiliation
Benha Assistant professor
Role Name Email Phone Street address
Scientific Enquiries Saad Saad saadibrahim_7@yahoo.com 00201223142889 Oman st
City Postal code Country Position/Affiliation
Giza 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