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The Effects of Different Clonidine Concentrations on Axillary Brachial Plexus Block With 1,5% Lidocaine

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ClinicalTrials.gov Identifier: NCT01620112
Recruitment Status : Completed
First Posted : June 15, 2012
Last Update Posted : June 15, 2012
Sponsor:
Information provided by (Responsible Party):
Alexandra Rezende Assad, Universidade Federal do Rio de Janeiro

Brief Summary:
The purpose of this study is to determine whether different clonidine concentration on axillary brachial plexus block with 1,5% lidocaine for upper limb surgery may influence the sensory and motor block onset time and duration, postoperative analgesia duration, postoperative pain intensity

Condition or disease Intervention/treatment Phase
Fascicular Block Motor Activity Pain, Postoperative Latency Period Drug: high Clonidine concentration Drug: low clonidine concentration Drug: Lidocaine Drug: Lidocaine 40 ml Phase 2

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 : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Official Title: The Effects of Different Clonidine Concentrations on Axillary Brachial Plexus Block With 1,5% Lidocaine for Upper Limb Surgery: a Prospective Randomized Study
Study Start Date : February 2009
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011


Arm Intervention/treatment
Active Comparator: low clonidine concentration
clonidine concentration 1 ml on 40 ml of lidocaine 1.5% for upper brachial plexus
Drug: low clonidine concentration
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
Drug: Lidocaine
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
Drug: high Clonidine concentration
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
Drug: Lidocaine 40 ml
Lidocaine 40 ml 1,5% 600 mg single injection for axillary brachial plexus block for upper limb surgery




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. postoperative analgesia duration [ Time Frame: 24 hours ]
    to compare two concentrations of clonidine on different volumes of lidocaine, in terms of postoperative analgesia duration

  3. 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

  4. postoperative pain intensity [ Time Frame: 24 hours ]
    to compare two concentrations of clonidine on different volumes of lidocaine, in terms postoperative pain intensity



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Responsible Party: Alexandra Rezende Assad, Assad AR, Universidade Federal do Rio de Janeiro
ClinicalTrials.gov Identifier: NCT01620112     History of Changes
Other Study ID Numbers: 090/2002
First Posted: June 15, 2012    Key Record Dates
Last Update Posted: June 15, 2012
Last Verified: June 2012

Keywords provided by Alexandra Rezende Assad, Universidade Federal do Rio de Janeiro:
brachial plexus
lidocaine
alfa 2 adrenergic receptor clonidine
orthopedic procedure

Additional relevant MeSH terms:
Clonidine
Pain, Postoperative
Bundle-Branch Block
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Heart Block
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Analgesics
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Adrenergic alpha-2 Receptor Agonists