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.: PACTR201708002462294 Date of Approval: 18/07/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Intercostbrachial Nerve Block
Official scientific title Comparative study between two different techniques of intercostobrachial nerve blocks together with brachial plexus block during superficialization of arteriovenous fistula
Brief summary describing the background and objectives of the trial Any block modality of the brachial plexus spares block of the intercostobrachial nerve and its supplied part of the axilla and upper part of the arm. Primary aim: To compare two techniques of intercostobrachial nerve block supplementing infraclavicular brachial plexus block during superficialization of upper limb arteriovenous fistula operation regarding the volume of local anesthetic infiltration needed to complete the procedure under regional anesthesia. Secondary aim: To evaluate the two techniques regarding the onset of action, success rate and side effects if any
Type of trial RCT
Acronym (If the trial has an acronym then please provide) Intercostobrachial N
Disease(s) or condition(s) being studied Arteriovenous fistula,Circulatory System
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/08/2017
Actual trial start date
Anticipated date of last follow up 28/02/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 0
Actual target sample size (number of participants) 40
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 by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Proximal ultrasound guided intercostobrachial nerve block 10 ml of 0.25 % plain bupivacaine before surgery once The ultrasound probe will be moved distally and laterally counting the ribs starting from the 1st rib under the axillary artery till the 2nd rib and following the pectoralis minor muscle. The serratus anterior muscle will appear covering the ribs. 10 ml of 0.25 % plain bupivacaine will be injected in an in plane approach at the lateral border of the pectoralis minor muscle 20
Control Group Distal ultrasound guided intercostobrachial nerve block 10 ml of 0.25 % plain bupivacaine before surgery Once The ultrasound probe will be moved distally to the medial side of the upper arm at the level of insertion of the deltoid muscle and 10 ml of 0.25 % plain bupivacaine will be infiltrated subcutaneously in an in plane approach 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Adult patients ASA II or III Scheduled for superficialization of arteriovenous fistula Patients with renal failure Contraindication to regional anesthesia Any mental or psychological problem 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 15/06/2017 Alexandria Faculty of Medicine
Ethics Committee Address
Street address City Postal code Country
17 champolion st. Alexandria 21615 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome To compare two techniques of intercostobrachial nerve block supplementing infraclavicular brachial plexus block during superficialization of upper limb arteriovenous fistula operation regarding the volume of local anesthetic infiltration needed to complete the procedure under regional anesthesia Postoperatively
Secondary Outcome To evaluate the two techniques regarding the onset of action, success rate and side effects if any Postoperatively
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Alexandria Faculty of Medicine Champolion street Alexandria 21615 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Alexandria Faculty of Medicine 17 Champolion st. Alexandria 21615 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Alexandria Faculty of Medicine Champolion street Alexandria 21615 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Moustafa Abdelaziz Smouha, Antoniadis compound Alexandria 21311 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Moustafa Moustafa m.3abdelaziz@hotmail.com 00201222373407 Smouha, Antoniadis compound
City Postal code Country Position/Affiliation
Alexandria 21311 Egypt Assistant professor, Alexandria Faculty of Medicine
Role Name Email Phone Street address
Public Enquiries Maha Ghanem alexmedethics@yahoo.com 00201223374415 Champolion street
City Postal code Country Position/Affiliation
Alexandria 21615 Egypt Head of ethics committee, Alexandria Faculty of Medicine
Role Name Email Phone Street address
Scientific Enquiries Nagwa Elkobbia kobbia@yahoo.com 00201223368233 Smouha
City Postal code Country Position/Affiliation
Alexandria 21311 Egypt Professor of Anesthesia
REPORTING
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information