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Comparison of Quality of Supraclavicular, Infraclavicular and Axillary Approach of Ultrasound-guided Brachial Plexus Block

This study is not yet open for participant recruitment.
Verified September 2011 by Hillel Yaffe Medical Center
Sponsor:
Information provided by (Responsible Party):
Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier:
NCT01442558
First received: September 22, 2011
Last updated: September 27, 2011
Last verified: September 2011
History of Changes
  Purpose

The aim of this study is to compare the quality of 3 methods of ultrasound-guided brachial plexus blocks for surgical anesthesia


Condition Intervention
Pain
 Drug: Bupivacaine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hillel Yaffe Medical Center:

Primary Outcome Measures:
  • Quality of 3 different approaches to brachial plexus block [ Time Frame: Immediate ] [ Designated as safety issue: No ]
    Whether or not there is need for additional analgesic drugs or need to switch to general anesthesia


Estimated Enrollment: 150
Study Start Date: December 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: SCL
Supraclavicular ultrasound-guided brachial plexus block
 Drug: Bupivacaine
Bupivacaine 5 mg/cc with adrenaline 5 mcg/cc will be injected with complete spread of the drug around nerves.
Active Comparator: ICL
Infraclavicular ultrasound-guided brachial plexus block
 Drug: Bupivacaine
Bupivacaine 5 mg/cc with adrenaline 5 mcg/cc will be injected with complete spread of the drug around nerves.
Active Comparator: AX
Axillary ultrasound-guided brachial plexus block
 Drug: Bupivacaine
Bupivacaine 5 mg/cc with adrenaline 5 mcg/cc will be injected with complete spread of the drug around nerves.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ASA I-III physical status
  • Surgery of distal arm, forearm or hand

Exclusion Criteria:

  • Skin infection near block injection site
  • Allergy to local anesthetics
  • Peripheral neuropathy upper limb
  • INR of more than 1.4
  • Thrombocytopenia
  • Opioid dependency
  • Chronic pain syndrome
  • Lack of orientation to person, place and time
  • Patient refusal
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01442558

Contacts
Contact: Anatoly Stav, MD 972-4-6304529 stav@hy.health.gov.il

Locations
Israel
Hillel Yaffe Medical Center Not yet recruiting
Hadera, Israel, 38100
Contact: Anatoly Stav, MD         stav@hy.health.gov.il    
Principal Investigator: Anatoly Stav, MD            
Sponsors and Collaborators
Hillel Yaffe Medical Center
  More Information

No publications provided

Responsible Party: Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier: NCT01442558     History of Changes
Other Study ID Numbers: 0081-2011-HYMC
Study First Received: September 22, 2011
Last Updated: September 27, 2011
Health Authority: Israel: Ministry of Health

Keywords provided by Hillel Yaffe Medical Center:
relief
Intra-operative

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

ClinicalTrials.gov processed this record on May 19, 2013