Ultrasound-guided Supraclavicular Brachial Plexus Block in Elderly

NCT ID: NCT01467596

Last Updated: 2012-11-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2012-11-30

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.

Conditions

Arm Injuries; Anesthesia

Keywords

Ultrasound; Brachial block; Levobupivacaine; Minimum; Volume; Minimum volume of Levobupivacaine 0,5%

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Elderly population

MEAV50, MEAV95 Onset and duration of sensory and motor blockade

Group Type: EXPERIMENTAL

Elderly population, Middle aged population

Intervention Type: 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.

Middle aged population

MEAV50, MEAV95 Onset and duration of sensory and motor blockade

Group Type: ACTIVE_COMPARATOR

Elderly population, Middle aged population

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Levobupivacaine 0.5%; Lidocaine 2%

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Šarić, Jadranka Pavičić, M.D.

INDIV

Sponsor Role: lead

Responsible Party

Jadranka Pavičić Šarić

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

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jadranka Pavičić Šarić, MD

Role: PRINCIPAL_INVESTIGATOR

Locations

University Hospital Merkur

Zagreb, City of Zagreb, Croatia

University Hospital Merkur

Zagreb, Croatia, Croatia

Countries

Croatia

References

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

Reference Type: RESULT

Other Identifiers

EudraCT 2011-005432-26

Identifier Type: -

Identifier Source: org_study_id