Ultrasound-guided Supraclavicular Brachial Plexus Block in Elderly (US-SCB)
Primary Purpose
Arm Injuries, Anesthesia
Status
Completed
Phase
Not Applicable
Locations
Croatia
Study Type
Interventional
Intervention
Elderly population, Middle aged population
Sponsored by
About this trial
This is an interventional treatment trial for Arm Injuries focused on measuring Ultrasound, Brachial block, Levobupivacaine, Minimum, Volume, Minimum volume of Levobupivacaine 0,5%
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
Sites / Locations
- University Hospital Merkur
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Elderly population
Middle aged population
Arm Description
MEAV50, MEAV95 Onset and duration of sensory and motor blockade
MEAV50, MEAV95 Onset and duration of sensory and motor blockade
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Ultrasound-guided Supraclavicular Brachial Plexus Block in...
Sensory and motor block onset time and duration for each nerve (median, radial, ulnar and musculocutaneous) and for the group.
Full Information
NCT ID
NCT01467596
First Posted
November 4, 2011
Last Updated
November 14, 2012
Sponsor
Šarić, Jadranka Pavičić, M.D.
1. Study Identification
Unique Protocol Identification Number
NCT01467596
Brief Title
Ultrasound-guided Supraclavicular Brachial Plexus Block in Elderly
Acronym
US-SCB
Official Title
Effects of Age on Minimum Effective Volume of Local Anesthetic for Ultrasound-guided Supraclavicular Brachial Plexus Block (US-SCB)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Šarić, Jadranka Pavičić, M.D.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arm Injuries, Anesthesia
Keywords
Ultrasound, Brachial block, Levobupivacaine, Minimum, Volume, Minimum volume of Levobupivacaine 0,5%
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Non-Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Elderly population
Arm Type
Experimental
Arm Description
MEAV50, MEAV95 Onset and duration of sensory and motor blockade
Arm Title
Middle aged population
Arm Type
Active Comparator
Arm Description
MEAV50, MEAV95 Onset and duration of sensory and motor blockade
Intervention Type
Device
Intervention Name(s)
Elderly population, Middle aged population
Other Intervention Name(s)
Levobupivacaine 0.5%, Lidocaine 2%
Intervention Description
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.
Primary Outcome Measure Information:
Title
Ultrasound-guided Supraclavicular Brachial Plexus Block in Elderly
Description
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).
Time Frame
A blinded Assistant assess sensory and motor blockade in a 5-min intervals up to 30 minutes
Secondary Outcome Measure Information:
Title
Ultrasound-guided Supraclavicular Brachial Plexus Block in...
Description
Sensory and motor block onset time and duration for each nerve (median, radial, ulnar and musculocutaneous) and for the group.
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).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jadranka Pavičić Šarić, MD
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Merkur
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
12. IPD Sharing Statement
Citations:
Citation
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
Results Reference
result
Learn more about this trial
Ultrasound-guided Supraclavicular Brachial Plexus Block in Elderly
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