Comparison Between Epinephrine and Clonidine as Adjuvants to Lidocaine in Axillary Brachial Plexus Block.

NCT03207022 | Completed Results

• 1 other identifier: ECM 4 (aa)
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

Adjuncts to local anaesthetics for the peripheral nerve blocks such as epinephrine, clonidine and opioids have been widely used to enhance quality, duration of anaesthesia and postoperative analgesia. Clonidine, an α2-adrenergic agonist, when combined with local anaesthetics in axillary brachial plexus block has shown to decrease block onset time and prolong the duration of anaesthesia. We propose to compare the effects of combining both adjuvants to 20 mL of lidocaine 2% on the onset of ultrasound guided axillary brachial plexus block.

Conditions

Brachial Plexus Blockade

Outcome Measures

Primary Outcomes (1)

• Onset of Sensory Block

  Time taken for onset of sensory axillary brachial plexus block

  1 day

Secondary Outcomes (2)

• Onset of Motor Block.

  1 day

• Duration of Sensory and Motor Block

  1 day

Study Arms (2)

lidocaine 2% with normal saline

ACTIVE COMPARATOR

Patients will receive ultrasound guided axillary brachial plexus block with 20 ml of lidocaine 2% with epinephrine mixed with 2 ml of 0.9% normal saline.

Procedure: axillary brachial plexus block

lidocaine 2% with clonidine

EXPERIMENTAL

Patients will receive ultrasound guided axillary brachial plexus block with 20 ml of lidocaine 2% with epinephrine mixed with clonidine 1µg/kg in 2 ml of 0.9% normal saline.

Procedure: axillary brachial plexus block

Interventions

axillary brachial plexus block PROCEDURE

ultrasound guided axillary brachial plexus block with 20 ml local anaesthetic lidocaine with epinephrine and clonidine

lidocaine 2% with clonidine; lidocaine 2% with normal saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA 1-2
• Patients age \>18 years
• Undergoing elective upper limb (forearm, wrist or hand) surgery.

You may not qualify if:

• Contraindications to regional anaesthesia
• Hypersensitivity to amide local anaesthetics.
• Chronic pain
• Language barrier
• Neuromuscular disorders or peripheral neuropathy
• H/o postural hypotension or autonomic dysfunction.
• Patients with a known sensitivity for local anaesthetics
• Body mass index \> 35
• History of hepatic and renal insufficiency
• Pregnancy
• Cognitive or psychiatric disorder
• Cardiac conduction abnormality.
• Anti arrythmic or adrenergic medications.

Sponsors & Collaborators

• Cork University Hospital: lead

Results Point of Contact

• Title: Dr Anil Ranganath
• Organization: Cork University Hospital

drmrak.2@gmail.com

Study Officials

• Anil Ranganath

  Cork University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr (Fellow in Regional Anaesthesia)

Study Record Dates

• First Submitted: May 7, 2017
• First Posted: July 2, 2017
• Study Start: June 11, 2014
• Primary Completion: July 14, 2016
• Study Completion: July 14, 2016
• Last Updated: September 2, 2021
• Results First Posted: September 2, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share