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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06406712
Other study ID # new valley anesthesia g2
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 1, 2024
Est. completion date February 1, 2025

Study information

Verified date June 2024
Source New Valley University
Contact ahmed ismail, lecture
Phone 01097845491
Email ahmed_ismail87@med.nvu.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The retroclavicular (coracoid) approach for brachial plexus anesthesia is recognized for its facility and simplicity to perform . The block has been well described in the anesthesia community since it was first introduced by Hebbard and Royse in 2007 . In 2017, Luftig . first described the block's use in the ED setting for a variety of indications . Because of its different needle entry point, the retro clavicular (RCB) approach offers an almost perpendicular needle-ultrasound (US) beam angle.


Description:

Regional anesthesia (RA) offers several advantages over general anesthesia (GA) for upper limb orthopedic surgery. One of the advantages is the improvement in postoperative pain, which leads to decreased use of postoperative opioids needs and reduces the recovery time for patients . A variety of approaches for regional blockade for upper extremity surgery have been described. Dexamethasone is a corticosteroid drug that has been used as an adjuvant to reduce postoperative pain. The use of peri neural dexamethasone (i.e. dexamethasone added to the local anesthesia solution) as an adjuvant to peripheral nerve block to improve analgesia provided by local anesthetic alone . Peri neural dexamethasone, as an adjuvant to peripheral nerve block, has been associated with faster onset of anesthesia , longer duration of anesthesia/analgesia decreased postoperative pain intensity and decreased postoperative analgesia requirements compared with local anaesthetic alone . The exact mechanism by which dexamethasone reduces pain is not known. The decrease in pain intensity and the prolonged analgesia attained with the use of perineural dexamethasone may be the result of a local, or systemic action, or both . Dexamethasone may act locally on glucocorticosteroid receptors to induce vasoconstriction, thereby decreasing systemic absorption of local anaesthetics . Other potential mechanisms of action include suppression of C-fibre transmission of pain signals and direct action on the nerve cell to reduce neural discharge . Dexamethasone may act systemically by reducing the inflammatory response caused by surgical tissue injury .


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date February 1, 2025
Est. primary completion date January 1, 2025
Accepts healthy volunteers No
Gender All
Age group 20 Years to 65 Years
Eligibility Inclusion Criteria: - Patients undergoing upper limb vascular surgey . Exclusion Criteria: - - Contraindications to regional block (coagulopathy, infection at the needle insertion site, or diaphragmatic paralysis). - Altered conscious level. - Pregnancy. - Body mass index (BMI > 35). - Patients who have difficulty understanding the study protocol. - Patients who have any known contraindication to study medications. - Patient refusal.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
retroclavicular block
regional anesthesia

Locations

Country Name City State
Egypt Faculty of Medicine Asyut

Sponsors (1)

Lead Sponsor Collaborator
New Valley University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary sensory and motor duration of block efficacy of block 24 hours
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