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.: PACTR201711002713192 Date of Approval: 21/10/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Anti-inflammatory Effect of General Anesthesia plus Supraclavicular Peripheral Nerve Blocks After Distal Humeral and Elbow Surgery: Clinical and Labo
Official scientific title Anti-inflammatory Effect of General Anesthesia plus Supraclavicular Peripheral Nerve Blocks After Distal Humeral and Elbow Surgery: Clinical and Laboratory Comparison versus General Anesthesia Alone
Brief summary describing the background and objectives of the trial Regional anesthetic techniques provide efficient postoperative analgesia1,2. In particular Brachial Plexus block for upper limb surgeries3. Postoperative pain is mainly caused by tissue inflammation. Mediators of inflammation include bradykinins, serotonins, prostaglandins, histamine, leukotriens and cytokines4.cytokins are important mediators of local inflammatory response after surgery5. Among cytokines which affect these responses after surgery are tumor necrosis factor ¿ alpha (TNF-¿), interleukin- 6 ( IL-6), and (IL-10). The balance between proinflammatory cytokines (IL-6) and TNF-¿. And anti-inflammatory cytokines (IL-10) limit the spread of infection, tissue injury and promote tissue healing and repair by their local and systemic reactions6,7.So, in our study we will try to compare the effect of supraclavicular brachial plexus block versus general anesthesia on the cytokine response (inflammatory and anti-inflammatory).and the effect of the inflammatory response clinically on the operated arm (oedema and skin temperature) and the healing power. We expect that (general Anesthesia versus Supraclavicular block) will be better than general anesthesia alone.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Injury, Occupational Diseases, Poisoning,post operative pain in upper limb ORIF in limb fractures,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 31/08/2017
Actual trial start date 31/08/2017
Anticipated date of last follow up 31/01/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants) 60
Recruitment status 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 radomisation table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used) Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group General anesthesia alone Before surgery (D0), (D1), (D4) and (D7) clinical and biological 30
Experimental Group General Anesthesia plus Supraclavicular blocks Before surgery (D0), (D1), (D4) and (D7) clinical (1- The circumference and skin temperature of the operated site and contralateral side,oedema, and biological 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Sixty Patients of both genders ASA ( I¿II - III), aged from 18 to 75 years will be randomly allocated either to receive general anesthesia alone (20) patients group GA , or general anesthesia + supraclavicular block (GAB) (30) patients. Exclusion criteria include previous surgery or trauma on the upper limb, current use or previous use of corticosteroids, systemic illness known to affect the inflammatory changes such as rheumatoid arthritis, patients with Congestive heart failure, diabetes mellitus, hypertension, malignancy , patients with coagulopathies or on anticoagulants or antiplatelet therapy. 18 Year(s) 75 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 15/10/2017 Fayoum University Ethical Committee No R65
Ethics Committee Address
Street address City Postal code Country
Fayoum University District Fayoum 63514 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome cytokine response (inflammatory:IL-6), (TNF-¿ and anti-inflammatory(IL-10) ) just before induction of anesthesia, at the end of the surgery and 6 hours after completion of the surgery, day 1 (D1) and (D7).
Primary Outcome 5- Morphine consumption postoperatively in the first 24 hours by PCA between the two groups.
Secondary Outcome 1- The circumference and skin temperature of the operated site and contralateral side. Before surgery (D0), (D1), (D4) and (D7)
Secondary Outcome 2- Oedema will be measured thread and compared witth the contralateral side and by oedema score. 2- Oedema will be measured thread and compared witth the contralateral side and by oedema score.
Secondary Outcome 3- Pain at rest and at movement will be measured by (VAS) from (0¿10) measured at D1, D4, D7, M1, M2. Physical therapy starts after 24 hours with passive and active mobilization of the operated arm.
Secondary Outcome 4- Healing power of wound: Assessment by Bates-Jensen wound assessment tool (1-13) (D4, D7, M1, M3) comparing the two groups.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Fayoum University Hospitals Fayoum University District Fayoum 63514 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
faculty of medicine Fayoum University Fayoum University district fayoum 63514 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Fayoum University Hospitals Fayoum University Hospitals Fayoum 63514 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Joseph Makram Botros 105 Toman Bai Street, Zeitoun Cairo 11321 Egypt
Atef Mohammad Sayed Khalil Fayoum University Hospitals, University district fayoum 63514 Egypt
Sylvanna Nady Gaber Doss 105 Toman Bai Street, Zeitoun Cairo 11321 Egypt
Joseph Makram Botros 105 Toman Bai Street, Zeitoun Cairo 11321 Egypt
Atef Mohammad Sayed Khalil Fayoum University Hospitals, University district fayoum 63514 Egypt
Sylvanna Nady Gaber Doss 105 Toman Bai Street, Zeitoun Cairo 11321 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Joseph Makram Botros dr_jo27@yahoo.com 020-02 24511807- 01227598825 105 Toman Bai street,Zeitoun
City Postal code Country Position/Affiliation
Cairo 11321 Egypt Lecturer of Anesthesiology, Pain, and Intensive Care, Fayoum University
Role Name Email Phone Street address
Public Enquiries Atef Mohamed Sayed Khalil dr.atef.khalil@gmail.com 020-084-01016581609 Fayoum University District
City Postal code Country Position/Affiliation
Fayoum 63514 Egypt Lecturer of Anesthesiology Fayoum University
Role Name Email Phone Street address
Scientific Enquiries Sylvanna Nady Gaber Doss dr_jo27@yahoo.com 01002864104 105 Toman Bai Street, Zeitoun
City Postal code Country Position/Affiliation
Cairo 11321 Egypt Lecturer of Microbiology and Immunology, Fayoum University
REPORTING
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