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

November 4, 2011
November 14, 2012
November 2011
November 2012   (final data collection date for primary outcome measure)
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).
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).
Complete list of historical versions of study NCT01467596 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Ultrasound-guided Supraclavicular Brachial Plexus Block in Elderly
Effects of Age on Minimum Effective Volume of Local Anesthetic for Ultrasound-guided Supraclavicular Brachial Plexus Block (US-SCB)

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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
  • Arm Injuries
  • Anesthesia
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%
  • Experimental: Elderly population
    MEAV50, MEAV95 Onset and duration of sensory and motor blockade
    Intervention: Device: Elderly population, Middle aged population
  • Active Comparator: Middle aged population
    MEAV50, MEAV95 Onset and duration of sensory and motor blockade
    Intervention: Device: Elderly population, Middle aged population
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
44
November 2012
November 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 95 Years
No
Contact information is only displayed when the study is recruiting subjects
Croatia
 
NCT01467596
EudraCT 2011-005432-26
No
Jadranka Pavičić Šarić, Šarić, Jadranka Pavičić, M.D.
Šarić, Jadranka Pavičić, M.D.
Not Provided
Principal Investigator: Jadranka Pavičić Šarić, MD
Šarić, Jadranka Pavičić, M.D.
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP