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

NCT ID: NCT01620112

Last Updated: 2012-06-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2011-07-31

Brief Summary

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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

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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.

Conditions

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Fascicular Block Motor Activity Pain, Postoperative Latency Period

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Caregivers

Study Groups

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low clonidine concentration

clonidine concentration 1 ml on 40 ml of lidocaine 1.5% for upper brachial plexus

Group Type ACTIVE_COMPARATOR

low clonidine concentration

Intervention Type DRUG

Clonidine 1 ml - 150 mcg on 40 ml of lidocaine 1,5% - single injection on axillary brachial plexus block for upper limb

lidocaine 20 ml 1,5%

lidocaine 20 ml 1,5% without clonidine for axillary brachial plexus block for upper limb surgery

Group Type ACTIVE_COMPARATOR

Lidocaine

Intervention Type DRUG

Lidocaine 1,5% 20 ml 300 mg for single injection on axillary brachial plexus block for upper lim surgery

high clonidine concentration

clonidine concentration 150 mcg on 20 ml of lidocaine 1,5% for upper brachial plexus

Group Type ACTIVE_COMPARATOR

high Clonidine concentration

Intervention Type DRUG

Clonidine 1 ml - 150 mcg on 20 ml de lidocaine 1,5% on axillary brachial plexus block for upper limb surgery

40 ml lidocaine 1,5%

40 ml of lidocaine 1,5% without clonidine for upper brachial plexus

Group Type ACTIVE_COMPARATOR

Lidocaine 40 ml

Intervention Type DRUG

Lidocaine 40 ml 1,5% 600 mg single injection for axillary brachial plexus block for upper limb surgery

Interventions

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high Clonidine concentration

Clonidine 1 ml - 150 mcg on 20 ml de lidocaine 1,5% on axillary brachial plexus block for upper limb surgery

Intervention Type 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

Intervention Type DRUG

Lidocaine

Lidocaine 1,5% 20 ml 300 mg for single injection on axillary brachial plexus block for upper lim surgery

Intervention Type DRUG

Lidocaine 40 ml

Lidocaine 40 ml 1,5% 600 mg single injection for axillary brachial plexus block for upper limb surgery

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidade Federal do Rio de Janeiro

OTHER

Sponsor Role lead

Responsible Party

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Alexandra Rezende Assad

Assad AR

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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090/2002

Identifier Type: -

Identifier Source: org_study_id

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