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.: PACTR201702002032348 Date of Approval: 11/02/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of combined ultrasound guided superficial cervical plexus and interscalene brachial plexus blocks in pain with fracture clavicle
Official scientific title A Comparative Study of Ultrasound guided superficial cervical plexus block and combined superficial cervical plexus and interscalene brachial plexus block for postoperative pain management in fracture clavicle surgeries.
Brief summary describing the background and objectives of the trial Clavicular fractures account for 35% of injures of shoulder girdle. Undisplaced Clavicular fractures are usually managed conservatively while surgical fixation is performed in young patients with displaced fractures for optimizing the outcome. The dilemma in anesthetic management of Clavicular fractures is the innervation of the clavicle. Although modern text books and atlas of regional anesthesia agree that supraclavicular nerves supply the skin overlying the clavicle but innervation of bone itself is conflicting. So from clinical point of view surgical management of Clavicular fractures can be performed using SCP block or combined SCP & ISBP blocks. It is very important to avoid unnecessary blocks for patient safety. This study is designed to To compare between the efficacies of ultrasound guided superficial cervical plexus block, and the combined ultrasound guided superficial cervical plexus and interscalene brachial plexus block for postoperative analgesia in patients with fracture clavicle
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Musculoskeletal Diseases,perio-perative analgesia
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 16/06/2016
Actual trial start date 25/02/2017
Anticipated date of last follow up 01/08/2017
Actual Last follow-up date 01/11/2019
Anticipated target sample size (number of participants) 52
Actual target sample size (number of participants) 60
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
31024/6/16 Research ethics committiee faculty of medicine tanta university
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomisation using a radomisation table created 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 Combined Superficial cervical plexus and Interscalene block group once Intra-operative before surgical incision Patients will placed in the lateral decubitus position with the operative side uppermost. Using US 6-13 MHz linear probe 10 ml of bupivacine 0.5 injected in the Superficial cervical plexus between sternocleidomastoid and scalene muscles and then another 15 ml injected on the brachial plexus in the interscalene groove 30 Active-Treatment of Control Group
Control Group Superficial cervical plexus block group once Intra-operative before surgical incision Patients will placed in the lateral decubitus position with the operative side uppermost. Using US 6-13 MHz linear probe, the midpoint of the sternocleidomastoid muscle will be scanned to reveal the intermuscular plane between the sternocleidomastoid and scalene muscles. Using a lateral to medial in-plane technique block needle will deposit 10 ml of bupivacaine 0.5 inbetween 30 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
ASA class I and II patients scheduled for fracture clavicle fixation Patient¿s refusal. Cerebrovascular disease. History of opioid consumption or drug abuse. Infection or skin disease at the site of procedure. Coagulopathy (INR >1.5, platelets < 80.000). 18 Year(s) 60 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 01/06/2016 Research ethics committe faculty of medicine tanta university
Ethics Committee Address
Street address City Postal code Country
El Gaish street Tanta 31527 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Success of the technique From the injection till the skin insision
Secondary Outcome Duration of the block begins from the ultrasound probe is applied till the injection is finished
Secondary Outcome Postoperative pain at 2h, 4h, 8h, 12h, 18h and 24h after recovery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta university hospitals El-Gaish street Tanta 31527 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Tanta University hospitals El-Gaish street Tanta 31527 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Anesthesia department Faculty of medicine tanta university El-Gaish street Tanta 31527 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Mohamed Elsayed Afandy 30th Anas ibn malek street Elmahala elkobra 31816 Egypt
Mohammed Elbrol 9th Abd Elgaleel street Tanta 31528 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Afandy mohamedafandy811@yahoo.com 0201145751176 Anas ibn malek st-mansheet elbakrey
City Postal code Country Position/Affiliation
Elmahala elkobra 31816 Egypt lecturer of anesthesia and ICU
Role Name Email Phone Street address
Public Enquiries Sameh Abd Elkhalik dr_sameh_100@yahoo.com 0201002977048 10th Mostafa Kamel street
City Postal code Country Position/Affiliation
Tanta 31528 Egypt lecturer of anesthesia and ICU
Role Name Email Phone Street address
Public Enquiries Mohammed Elbrol moh7000@yahoo.com 0201063345623 Abd Elgaleel st
City Postal code Country Position/Affiliation
Tanta 31528 Egypt lecturer of anesthesia and ICU
Role Name Email Phone Street address
Scientific Enquiries Mohammed Elbrol moh7000@yahoo.com 0201063345623 Abd Elgaleel st
City Postal code Country Position/Affiliation
Tanta 31528 Egypt lecturer of anesthesia and ICU
REPORTING
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