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 |
|
|