- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06262893
Effect of Dexamethasone Adjuvant in Combined Supraclavicular Block and Suprascapular Block Versus Interscalene Block in Patients Undergoing Shoulder Arthroscopy
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mohamed Ahmed
- Phone Number: 01151994269
- Email: mohamedelkhatib90@gmail.com
Study Contact Backup
- Name: Mohamed Talaat
- Phone Number: +20 106 201 2031
Study Locations
-
-
-
Assiut, Egypt
- Recruiting
- Assiut University
-
Contact:
- Assiut University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
ASA status 1,2.
- Age 18 years or older
- Elective shoulder arthroscopic surgery under general anesthesia and nerve block performed preoperatively.
Exclusion Criteria:
• Patient refusal
- Serious cardiac arrhythmias (including atrial fibrillation) or unstable coronary artery disease.
- Use of drugs that act on the autonomic nervous system (including β- blockers).
- Coagulation disorders..
- Anatomical disorders and/or neuropathic disease.
- BMI above 40.
- History of substance abuse.
- Chronic use of psychotropic and/or opioid.
- History of psychiatric diseases needing treatment.
- Allergy to any drug in the study protocol.
- Failure of nerve block performed in the preoperative block room when tested prior to entering the operating room (i.e. lack of loss of sensation to ice at the shoulder incision level).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Interscalene block in shoulder arthroscopy
|
Effect of dexamethasone adjuvant in combined supraclavicular block and suprascapular block versus Interscalene block in patients undergoing shoulder arthroscopy.
|
|
Active Comparator: Combined Supraclavicular block and suprascapular block in shoulder arthroscopy
|
Effect of dexamethasone adjuvant in combined supraclavicular block and suprascapular block versus Interscalene block in patients undergoing shoulder arthroscopy.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative analgesia by visual analog scale (VAS).
Time Frame: 48 hours
|
The primary outcome of this study will be to evaluate and compare between suprascapular-supraclavicular nerve block in association with dexamethasone to that of the interscalene brachial plexus block on postoperative analgesia by vas score during 48h postoperatively ( 2h , 6h , 12h, 24h and 48h). The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). |
48 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Diaphragmatic excursion
Time Frame: 1hour postoperatively
|
Assessment of diaphragmatic excursion by ultrasound preoperatively and 1hour postoperatively
|
1hour postoperatively
|
Collaborators and Investigators
Sponsor
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
Other Study ID Numbers
- Shoulder nerve blocks
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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