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

Pain, Postoperative Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01620112
• Other study ID #: 090/2002
• Status: Completed
• Phase: Phase 2
• First received: June 9, 2012
• Last updated: June 14, 2012
• Start date: February 2009
• Est. completion date: July 2011

Study information

• Verified date: June 2012
• Source: Universidade Federal do Rio de Janeiro
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fascicular Block
• Latency Period
• Motor Activity
• Pain, Postoperative

Intervention

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
• 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
• Lidocaine
Lidocaine 1,5% 20 ml 300 mg for single injection on axillary brachial plexus block for upper lim surgery
• Lidocaine 40 ml
Lidocaine 40 ml 1,5% 600 mg single injection for axillary brachial plexus block for upper limb surgery

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal do Rio de Janeiro

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sensorial and motor block duration	to compare two concentrations of clonidine on different volumes of lidocaine, in terms of sensorial and motor block duration	24 hours after surgery	Yes
Secondary	adverse effects of additive clonidine on axillary brachial plexus block in upper limb surgery	analyse the adverse effects of additive clonidine on axillary brachial plexus block in upper limb surgery	24 hours after surgery	Yes
Secondary	postoperative analgesia duration	to compare two concentrations of clonidine on different volumes of lidocaine, in terms of postoperative analgesia duration	24 hours	Yes
Secondary	sensorial and motor block onset time	to compare two concentrations of clonidine on different volumes of lidocaine, in terms of sensorial and motor block onset time	24 hours	Yes
Secondary	postoperative pain intensity	to compare two concentrations of clonidine on different volumes of lidocaine, in terms postoperative pain intensity	24 hours	Yes