- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06406712
Retroclavicular Block in Vascular Surgey
Efficacy of Retroclavicular Dexamethasone With Bupivacaine in Patients Undergoing Upper Limb Vascular Surgeries
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.
Study Overview
Detailed 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 .
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: ahmed ismail, lecture
- Phone Number: 01097845491
- Email: ahmed_ismail87@med.nvu.edu.eg
Study Locations
-
-
-
Asyut, Egypt
- Recruiting
- Faculty of medicine
-
Contact:
- hassan abdel lataif, prof
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: dexamethasone with bupivacaine in retroclavicular block
40patients received 40 ml of bupivacaine 0.25%(in total 100 mg)+1 ml of dexamethasone)
|
regional anesthesia
|
|
Active Comparator: bupivacaine in retroclavicular block (control group)
: 40patients received.
40 ml of bupivacaine 0.25%(in total 100 mg)+1 ml saline
|
regional anesthesia
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
sensory and motor duration of block
Time Frame: 24 hours
|
efficacy of block
|
24 hours
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: ahmed ismail, lecture, faculty of medicine , new valley university
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- new valley anesthesia g2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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