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Does a Low Volume Ultrasound-Guided Technique Reduce Common Complications of Interscalene Brachial Plexus Block?

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00497354
Recruitment Status : Completed
First Posted : July 6, 2007
Last Update Posted : June 15, 2010
Information provided by:
Sunnybrook Health Sciences Centre

Brief Summary:
Peripheral nerve blocks provide many advantages for patients (excellent pain control and reduction in nausea) undergoing upper and lower limb surgery however several commonly occurring complications can produce annoying but sometimes serious adverse effects. The interscalene brachial plexus block (ISBPB) is one such technique, commonly performed for shoulder surgery, but also produces paralysis of the diaphragm, Horner's syndrome and sometimes vocal cord paralysis with standard volumes of local anesthetic. This threat of these side effects limits the use of ISBPB in many patients who would particularly benefit e.g. patients with lung disease. Recently the use of ultrasound guidance is allowing practitioners to place smaller volumes of local anesthetic with much greater accuracy. This can potentially avoid anesthetizing important adjacent nerves to the target structure. If ultrasound-guided techniques with smaller volumes of local anesthetic could be demonstrated to reduce the incidence of complications without reducing effectiveness this would be very beneficial for patients.This will be the first randomized, double blind study to evaluate if an ultrasound-guided ISBPB with low volumes of local anesthetic can reduce complications for patients whilst maintaining quality of anesthesia and pain relief in the intra-operative and postoperative period.

Condition or disease Intervention/treatment Phase
Pain After Shoulder Surgery Drug: Variation in volume of local anesthetic Procedure: Ultrasound-guided interscalene brachial plexus block Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Does a Low Volume Ultrasound-Guided Technique Reduce Common Complications of Interscalene Brachial Plexus Block?
Study Start Date : July 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Primary Outcome Measures :
  1. Diaphragmatic paresis [ Time Frame: 30 minutes post block insertion ]

Secondary Outcome Measures :
  1. Analgesic efficacy [ Time Frame: 30,60,90,120 minutes post surgery ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients undergoing elective shoulder surgery.
  • Patients aged >=18 and <=70 years
  • BMI<35

Exclusion Criteria:

  • Preexisting COPD
  • Unstable asthma
  • Psychiatric history
  • Allergy to ropivacaine.
  • Opioid tolerance (>30mg oral morphine or equivalent/day)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00497354

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Canada, Ontario
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M5N3M5
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
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Principal Investigator: Colin JL McCartney, FRCA Sunnybrook Health Sciences Centre
Layout table for additonal information Identifier: NCT00497354    
Other Study ID Numbers: SHSCA01
First Posted: July 6, 2007    Key Record Dates
Last Update Posted: June 15, 2010
Last Verified: June 2010
Keywords provided by Sunnybrook Health Sciences Centre:
Ultrasound, Complications, Regional Anesthesia
Additional relevant MeSH terms:
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Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents