Skip to main content
OpenTrials
Completed

NCT Number: NCT01467596

Ultrasound-guided Supraclavicular Brachial Plexus Block in Elderly

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Arm Injuries Anesthesia Wounds and Injuries

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Merkur, Zagreb, City of Zagreb, Croatia

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Elderly population, Middle aged population

Device

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: Levobupivacaine 0.5%, Lidocaine 2%

Primary outcomes

  1. Ultrasound-guided Supraclavicular Brachial Plexus Block in Elderly

    Time frame: 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 outcomes

  1. Ultrasound-guided Supraclavicular Brachial Plexus Block in...

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Šarić, Jadranka Pavičić, M.D.

Indiv

Registry information

Official study title

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

Acronym: US-SCB

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Nov 8, 2011
Registry last updated
Nov 15, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.