Ultrasound-guided Supraclavicular Brachial Plexus Block in Elderly

NCT01467596 | Completed

• 1 other identifier: EudraCT 2011-005432-26
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 2

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.

Conditions

Arm Injuries; Anesthesia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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).

Study Arms (2)

Elderly population

EXPERIMENTAL

MEAV50, MEAV95 Onset and duration of sensory and motor blockade

Device: Elderly population, Middle aged population

Middle aged population

ACTIVE COMPARATOR

MEAV50, MEAV95 Onset and duration of sensory and motor blockade

Device: Elderly population, Middle aged population

Interventions

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.

Also known as: Levobupivacaine 0.5%, Lidocaine 2%

Elderly population; Middle aged population

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Šarić, Jadranka Pavičić, M.D.: lead

Study Sites (2)

University Hospital Merkur

Zagreb, City of Zagreb, 10000, Croatia

Location

University Hospital Merkur

Zagreb, Croatia, 10000, Croatia

Location

Related Publications (1)

• 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

  RESULT

MeSH Terms

Conditions

Arm Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Jadranka Pavičić Šarić, MD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDIV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Effects of Age on Minimum Effective Volume of Local Anesthetic for Ultrasound-guided Supraclavicular Brachial Plexus Block (US-SCB)

Study Record Dates

• First Submitted: November 4, 2011
• First Posted: November 8, 2011
• Study Start: November 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: November 15, 2012

Record last verified: 2012-11

Locations

CR (2)