- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02049970
Effect of the Addition of Dexmedetomidine to Bupivacaine During Supraclavicular Brachial Plexus Blockade
November 7, 2014 updated by: Recep Aksu, TC Erciyes University
Effect of the Addition of Dexmedetomidine to Bupivacaine During Supraclavicular Brachial Plexus Blockade for Forearm Surgery.
the aim of this study was effect of the addition of dexmedetomidine to bupivacaine during supraclavicular brachial plexus blockade for forearm surgery, by low doses bupivacaine providing prolonged analgesia after surgery.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
Anaesthesia for surgeries to the upper extremity commonly is provided using brachial plexus anaesthesia.Various local anaesthetic mixtures can be used to prolong local anaesthesia duration and epinephrine , opioids and dexmedetomidine are frequently used for this purpose.
this study was conducted to compare the effects of adding dexmedetomidine to local anaesthetics in the supraclavicular brachial plexus block by using nerve stimulators and ultrasonography guided.
dexmedetomidine has also been found the prolong the duration of bupivacaine infraclavicular brachial plexus block.
Study Type
Interventional
Enrollment (Actual)
44
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Kayseri, Turkey, 38039
- Erciyes University Medical Faculty
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 18-65 age
- unwanted general anaesthesia
- ASA 1-2
- single forearm, arm surgery
Exclusion Criteria:
- major psychiatric problems
- major neurologic deficits
- coagulopathy
- drug allergies
- chronic analgesic used
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: dexmedetomidine and bupivacaine
Bupivacaine 50 mg and dexmedetomidine 1 microgram/kg
|
1 ml 100 mcg dexmedetomidine+ 15 ml 0.25 % bupivacaine are applied around brachial plexus
Other Names:
30 ml 0.25 % bupivacaine is applied around brachial plexus
Other Names:
|
|
Experimental: Bupivacaine and placebo
Bupivacaine 100 mg and SF 10 ml
|
1 ml 100 mcg dexmedetomidine+ 15 ml 0.25 % bupivacaine are applied around brachial plexus
Other Names:
30 ml 0.25 % bupivacaine is applied around brachial plexus
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
the duration of sensorial block
Time Frame: postoperative 1 day
|
pin-prick test
|
postoperative 1 day
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
the first time analgesic required
Time Frame: postoperative 1 day
|
postoperative 1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Recep Aksu, Ass.Prof.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2014
Primary Completion (Actual)
November 1, 2014
Study Completion (Actual)
November 1, 2014
Study Registration Dates
First Submitted
January 28, 2014
First Submitted That Met QC Criteria
January 28, 2014
First Posted (Estimate)
January 30, 2014
Study Record Updates
Last Update Posted (Estimate)
November 10, 2014
Last Update Submitted That Met QC Criteria
November 7, 2014
Last Verified
November 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics
- Analgesics, Non-Narcotic
- Adrenergic alpha-2 Receptor Agonists
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Hypnotics and Sedatives
- Anesthetics, Local
- Dexmedetomidine
- Bupivacaine
Other Study ID Numbers
- 2013/107
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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