- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01620112
The Effects of Different Clonidine Concentrations on Axillary Brachial Plexus Block With 1,5% Lidocaine
The Effects of Different Clonidine Concentrations on Axillary Brachial Plexus Block With 1,5% Lidocaine for Upper Limb Surgery: a Prospective Randomized Study
Study Overview
Status
Intervention / Treatment
Detailed Description
Brachial plexus blocks are frequently used in surgical procedures involving the upper limb because they facilitate surgical anaesthesia, muscle relaxation and post-operative analgesics.
Various drugs are used to supplement local anaesthetics during brachial plexus block. Many studies in the literature show that clonidine, which is an alpha-2 agonist, prolongs the length of anesthesia and post-operative analgesia.4,5 However, clonidine's side effects-such as hypotension, bradycardia and sedation can limit its use.
There are no studies comparing different clonidine concentrations on the axillary brachial block, so the hypothesis of the present study was that different clonidine concentrations and LA volumes may influence the anaesthesia and analgesia quality on this type of regional block.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- both genders,
- over 18 years old,
- American Society of Anesthesiologists (ASA) 1 to 3
Exclusion Criteria:
- patients with chronic use of analgesics and non-steroidal anti-inflammatories drugs,
- pregnant,
- with infection at the puncture site,
- coagulopathies or intolerance to drugs used in the study
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: low clonidine concentration
clonidine concentration 1 ml on 40 ml of lidocaine 1.5% for upper brachial plexus
|
Clonidine 1 ml - 150 mcg on 40 ml of lidocaine 1,5% - single injection on axillary brachial plexus block for upper limb
|
Active Comparator: lidocaine 20 ml 1,5%
lidocaine 20 ml 1,5% without clonidine for axillary brachial plexus block for upper limb surgery
|
Lidocaine 1,5% 20 ml 300 mg for single injection on axillary brachial plexus block for upper lim surgery
|
Active Comparator: high clonidine concentration
clonidine concentration 150 mcg on 20 ml of lidocaine 1,5% for upper brachial plexus
|
Clonidine 1 ml - 150 mcg on 20 ml de lidocaine 1,5% on axillary brachial plexus block for upper limb surgery
|
Active Comparator: 40 ml lidocaine 1,5%
40 ml of lidocaine 1,5% without clonidine for upper brachial plexus
|
Lidocaine 40 ml 1,5% 600 mg single injection for axillary brachial plexus block for upper limb surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
sensorial and motor block duration
Time Frame: 24 hours after surgery
|
to compare two concentrations of clonidine on different volumes of lidocaine, in terms of sensorial and motor block duration
|
24 hours after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
adverse effects of additive clonidine on axillary brachial plexus block in upper limb surgery
Time Frame: 24 hours after surgery
|
analyse the adverse effects of additive clonidine on axillary brachial plexus block in upper limb surgery
|
24 hours after surgery
|
postoperative analgesia duration
Time Frame: 24 hours
|
to compare two concentrations of clonidine on different volumes of lidocaine, in terms of postoperative analgesia duration
|
24 hours
|
sensorial and motor block onset time
Time Frame: 24 hours
|
to compare two concentrations of clonidine on different volumes of lidocaine, in terms of sensorial and motor block onset time
|
24 hours
|
postoperative pain intensity
Time Frame: 24 hours
|
to compare two concentrations of clonidine on different volumes of lidocaine, in terms postoperative pain intensity
|
24 hours
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Heart Diseases
- Cardiovascular Diseases
- Postoperative Complications
- Pain
- Neurologic Manifestations
- Arrhythmias, Cardiac
- Cardiac Conduction System Disease
- Heart Block
- Pain, Postoperative
- Bundle-Branch Block
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Antihypertensive Agents
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics
- Adrenergic alpha-2 Receptor Agonists
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Membrane Transport Modulators
- Anesthetics, Local
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Sympatholytics
- Lidocaine
- Clonidine
Other Study ID Numbers
- 090/2002
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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