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

June 9, 2012
June 14, 2012
February 2009
July 2011   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01620112 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
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

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Treatment
  • Fascicular Block
  • Motor Activity
  • Pain, Postoperative
  • Latency Period
  • 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
  • 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
  • Drug: Lidocaine
    Lidocaine 1,5% 20 ml 300 mg for single injection on axillary brachial plexus block for upper lim surgery
  • Drug: Lidocaine 40 ml
    Lidocaine 40 ml 1,5% 600 mg single injection for axillary brachial plexus block for upper limb surgery
  • Active Comparator: low clonidine concentration
    clonidine concentration 1 ml on 40 ml of lidocaine 1.5% for upper brachial plexus
    Intervention: Drug: low clonidine concentration
  • Active Comparator: lidocaine 20 ml 1,5%
    lidocaine 20 ml 1,5% without clonidine for axillary brachial plexus block for upper limb surgery
    Intervention: Drug: Lidocaine
  • Active Comparator: high clonidine concentration
    clonidine concentration 150 mcg on 20 ml of lidocaine 1,5% for upper brachial plexus
    Intervention: Drug: high Clonidine concentration
  • Active Comparator: 40 ml lidocaine 1,5%
    40 ml of lidocaine 1,5% without clonidine for upper brachial plexus
    Intervention: Drug: Lidocaine 40 ml
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
July 2011
July 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01620112
090/2002
Yes
Alexandra Rezende Assad, Federal University of Rio de Janeiro
Universidade Federal do Rio de Janeiro
Not Provided
Not Provided
Universidade Federal do Rio de Janeiro
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP