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

Phase 2

Completed

• Conditions: Fascicular Block; Motor Activity; Pain, Postoperative; Latency Period
• Interventions: Drug: low clonidine concentration; Drug: Lidocaine 40 ml; Drug: high Clonidine concentration; Drug: Lidocaine

• Registration Number: NCT01620112
• Lead Sponsor: 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

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 Timeline

• Study Start: 2009-02
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Status Verified: 2012-06
• Study First Submitted: 2012-06-09
• Study First Submitted QC: 2012-06-14
• Last Update Submitted: 2012-06-14
• Study First Posted: 2012-06-15
• Last Update Posted: 2012-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
low clonidine concentration	low clonidine concentration	clonidine concentration 1 ml on 40 ml of lidocaine 1.5% for upper brachial plexus
40 ml lidocaine 1,5%	Lidocaine 40 ml	40 ml of lidocaine 1,5% without clonidine for upper brachial plexus
high clonidine concentration	high Clonidine concentration	clonidine concentration 150 mcg on 20 ml of lidocaine 1,5% for upper brachial plexus
lidocaine 20 ml 1,5%	Lidocaine	lidocaine 20 ml 1,5% without clonidine for axillary brachial plexus block for upper limb surgery

Primary Outcome Measures

Name	Time	Method
sensorial and motor block duration	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

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