The Effects of Different Clonidine Concentrations on Axillary Brachial Plexus Block With 1,5% Lidocaine
This study has been completed.
Sponsor:
Federal University of Rio de Janeiro
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 Federal University of 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
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 Federal University of Rio de Janeiro:
|
brachial plexus lidocaine alfa 2 adrenergic receptor clonidine orthopedic procedure |
Additional relevant MeSH terms:
|
Bundle-Branch Block Pain, Postoperative Heart Block Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes Postoperative Complications Pain Signs and Symptoms Clonidine Lidocaine Antihypertensive Agents Cardiovascular Agents Therapeutic Uses |
Pharmacologic Actions Sympatholytics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Adrenergic alpha-2 Receptor Agonists Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Analgesics Sensory System Agents Central Nervous System Agents Anesthetics, Local |
ClinicalTrials.gov processed this record on May 23, 2013