Ultrasound-guided Supraclavicular Brachial Plexus Block in Elderly

Not Applicable

Completed

• Conditions: Arm Injuries; Anesthesia
• Interventions: Device: Elderly population, Middle aged population

• Registration Number: NCT01467596
• Lead Sponsor: Šarić, Jadranka Pavičić, M.D.

Brief Summary

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.

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 Timeline

• Study Start: 2011-11
• Study First Submitted: 2011-11-04
• Study First Submitted QC: 2011-11-07
• Study First Posted: 2011-11-08
• Status Verified: 2012-11
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Last Update Submitted: 2012-11-14
• Last Update Posted: 2012-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Elderly population	Elderly population, Middle aged population	MEAV50, MEAV95 Onset and duration of sensory and motor blockade
Middle aged population	Elderly population, Middle aged population	MEAV50, MEAV95 Onset and duration of sensory and motor blockade

Primary Outcome Measures

Name	Time	Method
Ultrasound-guided Supraclavicular Brachial Plexus Block in Elderly	A blinded Assistant assess sensory and motor blockade in a 5-min intervals up to 30 minutes	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).

Secondary Outcome Measures

Name	Time	Method
Ultrasound-guided Supraclavicular Brachial Plexus Block in...	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).	Sensory and motor block onset time and duration for each nerve (median, radial, ulnar and musculocutaneous) and for the group.

Trial Locations

Locations (1)

University Hospital Merkur; 🇭🇷 Zagreb, Croatia