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

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

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative; Motor Activity; Fascicular Block; Latency Period
• Intervention / Treatment: Drug: low clonidine concentration; Drug: Lidocaine; Drug: high Clonidine concentration; Drug: Lidocaine 40 ml

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
• Enrollment (Actual): 60
• Phase: Phase 2

Participation Criteria

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:

• 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

Number of Arms

4

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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
sensorial and motor block duration	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	analyse the adverse effects of additive clonidine on axillary brachial plexus block in upper limb surgery	24 hours after surgery
postoperative analgesia duration	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	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	to compare two concentrations of clonidine on different volumes of lidocaine, in terms postoperative pain intensity	24 hours

Collaborators and Investigators

• Sponsor: Universidade Federal do Rio de Janeiro

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (Actual): July 1, 2011
• Study Completion (Actual): July 1, 2011

Study Registration Dates

• First Submitted: June 9, 2012
• First Submitted That Met QC Criteria: June 14, 2012
• First Posted (Estimate): June 15, 2012

Study Record Updates

• Last Update Posted (Estimate): June 15, 2012
• Last Update Submitted That Met QC Criteria: June 14, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Keywords: lidocaine; brachial plexus; alfa 2 adrenergic receptor clonidine; orthopedic procedure
• 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