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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alexandra Rezende Assad, Federal University of Rio de Janeiro
ClinicalTrials.gov Identifier:
NCT01620112
First received: June 9, 2012
Last updated: June 14, 2012
Last verified: June 2012
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
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

Resource links provided by NLM:


Further study details as provided by Universidade Federal do Rio de Janeiro:

Primary Outcome Measures:
  • sensorial and motor block duration [ Time Frame: 24 hours after surgery ] [ Designated as safety issue: Yes ]
    to compare two concentrations of clonidine on different volumes of lidocaine, in terms of sensorial and motor block duration


Secondary Outcome Measures:
  • adverse effects of additive clonidine on axillary brachial plexus block in upper limb surgery [ Time Frame: 24 hours after surgery ] [ Designated as safety issue: Yes ]
    analyse the adverse effects of additive clonidine on axillary brachial plexus block in upper limb surgery

  • postoperative analgesia duration [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
    to compare two concentrations of clonidine on different volumes of lidocaine, in terms of postoperative analgesia duration

  • sensorial and motor block onset time [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
    to compare two concentrations of clonidine on different volumes of lidocaine, in terms of sensorial and motor block onset time

  • postoperative pain intensity [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
    to compare two concentrations of clonidine on different volumes of lidocaine, in terms postoperative pain intensity


Enrollment: 60
Study Start Date: February 2009
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Alexandra Rezende Assad, Assad AR, Federal University of Rio de Janeiro
ClinicalTrials.gov Identifier: NCT01620112     History of Changes
Other Study ID Numbers: 090/2002
Study First Received: June 9, 2012
Last Updated: June 14, 2012
Health Authority: Brazil: National Committee of Ethics in Research

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

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Pathologic Processes
Postoperative Complications
Signs and Symptoms
Clonidine
Lidocaine
Adrenergic Agents
Adrenergic Agonists
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Analgesics
Anesthetics
Anesthetics, Local
Anti-Arrhythmia Agents
Antihypertensive Agents
Autonomic Agents
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Sodium Channel Blockers
Sympatholytics
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014