- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07399691
Effect of Adding Dexamethasone to Bupivacaine in Ultrasound-Guided Supraclavicular Brachial Plexus Blocks Versus Bupivacaine Alone for Upper Limb Orthopaedic Surgery (SCBPBs)
- SCBPBs provides optimal conditions for procedures performed below the mid-upper arm (elbow, forearm, wrist, hand) due to its high success rate and ease of access.
- Dexamethasone, when administered perineurally as an adjuvant for a supraclavicular block, demonstrated early onset of sensory and motor block, a prolonged duration of sensory and motor block, and a lower number of rescue analgesics as compared to bupivacaine alone.
- A combination of dexamethasone and bupivacaine is paramount in adult orthopeadic patient to enhance the efficacy of pain management under ultrasound-guided supraclavicular brachial plexus block.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Āsela, Ethiopia
- Mohammed Gebi
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
Aged 18-60 years with ASA I and II who were scheduled for elective elbow, forearm, or hand surgery under ultrasound-guided supraclavicular block.
Exclusion Criteria:
Patients who refused, used local anaesthetics other than bupivacaine, had multiple traumas, addition of another additive, bleeding disorders, patients diagnosed with chronic pain, cancer pain, local infection at the injection site, history of local anaesthetic allergy, patients with anxiety, and inability to comprehend or use the pain rating scale
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Group DB
Patients received a supraclavicular brachial plexus block with dexamethasone 2 ml (8 mg) added to 38 ml of 0.25 % bupivacaine.
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Adding 8 mg of dexamethasone to bupivacaine for ultrasound-guided supraclavicular block
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Group B
Patients received a supraclavicular brachial plexus block with 40 ml of 0.25 % bupivacaine alone.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The onset of sensory and motor blockade, and the duration of sensory and motor blockade in minutes.
Time Frame: with in the first 24hrs after procedure
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with in the first 24hrs after procedure
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
postoperative pain score by a visual analogue scale
Time Frame: with in the first 24 hrs after procedure
|
This assesses behavioural or subjective phenomena by having the participant choose an alternative from a gradient ranging from 0 = (no pain) to 100 = worst possible pain.
Based on the VAS score, 0-20 mm = no pain; 21-40 mm = mild pain; 41-60 mm = moderate pain; 61-80 mm = severe pain; and 81-100 mm = the worst pain imaginable
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with in the first 24 hrs after procedure
|
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First analgesic request time
Time Frame: With in the first 24 hrs after surgery
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The first postoperative period, when patients require pain treatment if the visual analogue score is>4
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With in the first 24 hrs after surgery
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
- No-A/CHS/RC/19/2023
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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