Ultrasound-guided Supraclavicular Brachial Plexus Block in Elderly (US-SCB)

Effects of Age on Minimum Effective Volume of Local Anesthetic for Ultrasound-guided Supraclavicular Brachial Plexus Block (US-SCB)

The aim of this study is to determine the minimum effective volume of local anesthetic (50:50 mixture of 0.5% levobupivacaine and 2% lidocaine) required to produce an effective US-SCB for surgical anesthesia in 50% of patients and to calculate the effective volume required to produce an effective US-SCB in 95% of the patients (MEAV95) in elderly group (>65 years) and in middle aged group (<45years) of patients.

Study Overview

• Status: Completed
• Conditions: Arm Injuries; Anesthesia
• Intervention / Treatment: Device: Elderly population, Middle aged population

Detailed Description

We believe that known data regarding the minimum anesthetic volume required for effective US-SCB from middle age population can not be applicable to the elderly population since our preliminary data, presented at Euroanesthesia meeting in Amsterdam, 2011, and published in abstract form in the European Journal of Anaesthesiology, showed that involutional changes of brachial plexus in elderly, assessed by measuring the cross-sectional area (CSA) of brachial plexus at the first rib, allowed a 35% reduction in local anesthetic volume for an effective US-SCB for surgical anesthesia in elderly patients in comparison with the younger patients.

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Croatia
  • Zagreb, Croatia, 10000
    • University Hospital Merkur

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 95 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• ASA 1 - 3 elderly patients (>65 years) scheduled for hand surgery
• ASA 1-3 middle aged patients (<45 years)

Exclusion Criteria:

• Cognitive impairment
• Coagulopathy
• Allergy to local anesthetics
• Infection at the puncture site,
• Body mass index > 35 kg/m2

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Elderly population; MEAV50, MEAV95 Onset and duration of sensory and motor blockade	Device: Elderly population, Middle aged population; The study method is a step-up/step-down sequence model where the dose of local anesthetic for the following patient is determined by the outcome of the preceding block. The starting dose of 50:50 mixture of 0.5% levobupivacaine and 2% lidocaine is 30 mL. In the case of block failure, the dose will be increased by 5 mL. Conversely, block success will result in a reduction in dose by 5 mL. A blinded assistant will assess sensory and motor blockade in each nerve territory ( the median, radial, ulnar and musculocutaneous) at 5-min intervals up to 30 min after completion of US-SCB. Effective US-SCB will be defined as complete sensory blockade in the distribution of the radial, ulnar, median and musculocutaneous nerve.; Other Names: Lidocaine 2%; Levobupivacaine 0.5%
ACTIVE_COMPARATOR: Middle aged population; MEAV50, MEAV95 Onset and duration of sensory and motor blockade	Device: Elderly population, Middle aged population; The study method is a step-up/step-down sequence model where the dose of local anesthetic for the following patient is determined by the outcome of the preceding block. The starting dose of 50:50 mixture of 0.5% levobupivacaine and 2% lidocaine is 30 mL. In the case of block failure, the dose will be increased by 5 mL. Conversely, block success will result in a reduction in dose by 5 mL. A blinded assistant will assess sensory and motor blockade in each nerve territory ( the median, radial, ulnar and musculocutaneous) at 5-min intervals up to 30 min after completion of US-SCB. Effective US-SCB will be defined as complete sensory blockade in the distribution of the radial, ulnar, median and musculocutaneous nerve.; Other Names: Lidocaine 2%; Levobupivacaine 0.5%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ultrasound-guided Supraclavicular Brachial Plexus Block in Elderly	Determining the minimum effective volume of a 50:50 mixture of levobupivacaine 0.5% and lidocaine 2% for successful supraclavicular brachial plexus block for hand surgery in 50% of elderly patients (MEAV50) and to calculate the effective volume in 95% of the elderly patients (MEAV95) as compared with control group (middle aged patients).	A blinded Assistant assess sensory and motor blockade in a 5-min intervals up to 30 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ultrasound-guided Supraclavicular Brachial Plexus Block in...	Sensory and motor block onset time and duration for each nerve (median, radial, ulnar and musculocutaneous) and for the group.	A blinded Assistant assess onset (in a 5-min intervals up to 30 minutes after completion of US-SCB) ) and duration of sensory and motor blockade (in a 30-min intervals after the completion of surgery).

Collaborators and Investigators

• Sponsor: Šarić, Jadranka Pavičić, M.D.
• Investigators: Principal Investigator: Jadranka Pavičić Šarić, MD

Publications and helpful links

General Publications

• Tomulic K, Pavicic Saric J, Acan I.Effect of age on anaesthetic volume for ultrasound guided supraclavicular brachial plexus block: 8AP2-8 June 2011 - Volume 28 - Issue - p 113 European Journal of Anaesthesiology

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (ACTUAL): November 1, 2012
• Study Completion (ACTUAL): November 1, 2012

Study Registration Dates

• First Submitted: November 4, 2011
• First Submitted That Met QC Criteria: November 7, 2011
• First Posted (ESTIMATE): November 8, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): November 15, 2012
• Last Update Submitted That Met QC Criteria: November 14, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Keywords: Ultrasound; Levobupivacaine; Minimum; Volume; Brachial block; Minimum volume of Levobupivacaine 0,5%
• Additional Relevant MeSH Terms: Wounds and Injuries; Arm Injuries; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine; Levobupivacaine
• Other Study ID Numbers: EudraCT 2011-005432-26