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NCT Number: NCT01620112

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

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

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Key information

Conditions

Fascicular Block Arrhythmias, Cardiac Behavior Bundle-Branch Block Cardiac Conduction System Disease Cardiovascular Diseases Heart Block Heart Diseases Latency Period Motor Activity Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

high Clonidine concentration

Drug

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

low clonidine concentration

Drug

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

Lidocaine

Drug

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

Lidocaine 40 ml

Drug

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Universidade Federal do Rio de Janeiro

Other

Registry information

Official study title

The Effects of Different Clonidine Concentrations on Axillary Brachial Plexus Block With 1,5% Lidocaine for Upper Limb Surgery: a Prospective Randomized Study

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jun 15, 2012
Registry last updated
Jun 15, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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