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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jadranka Pavičić Šarić, Šarić, Jadranka Pavičić, M.D.
ClinicalTrials.gov Identifier:
NCT01467596
First received: November 4, 2011
Last updated: November 14, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention
Arm Injuries
Anesthesia
Device: Elderly population, Middle aged population

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Age on Minimum Effective Volume of Local Anesthetic for Ultrasound-guided Supraclavicular Brachial Plexus Block (US-SCB)

Resource links provided by NLM:


Further study details as provided by Šarić, Jadranka Pavičić, M.D.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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:
  • 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). ] [ Designated as safety issue: No ]
    Sensory and motor block onset time and duration for each nerve (median, radial, ulnar and musculocutaneous) and for the group.


Enrollment: 44
Study Start Date: November 2011
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • Levobupivacaine 0.5%
  • Lidocaine 2%
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:
  • Levobupivacaine 0.5%
  • Lidocaine 2%

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.

  Eligibility

Ages Eligible for Study:   18 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01467596

Locations
Croatia
University Hospital Merkur
Zagreb, Croatia, 10000
Sponsors and Collaborators
Šarić, Jadranka Pavičić, M.D.
Investigators
Principal Investigator: Jadranka Pavičić Šarić, MD
  More Information

No publications provided

Responsible Party: Jadranka Pavičić Šarić, Effects of Age on Minimum Effective Volume of Local Anesthetic for Ultrasound-guided Supraclavicular Brachial Plexus Block (US-SCB), Šarić, Jadranka Pavičić, M.D.
ClinicalTrials.gov Identifier: NCT01467596     History of Changes
Other Study ID Numbers: EudraCT 2011-005432-26
Study First Received: November 4, 2011
Last Updated: November 14, 2012
Health Authority: Croatia: Ethics Committee

Keywords provided by Šarić, Jadranka Pavičić, M.D.:
Ultrasound
Brachial block
Levobupivacaine
Minimum
Volume
Minimum volume of Levobupivacaine 0,5%

Additional relevant MeSH terms:
Arm Injuries
Wounds and Injuries
Anesthetics, Local
Bupivacaine
Levobupivacaine
Anesthetics
Central Nervous System Agents
Central Nervous System Depressants
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014