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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00497354
First Posted: July 6, 2007
Last Update Posted: June 15, 2010
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.
Information provided by:
Sunnybrook Health Sciences Centre
  Purpose
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 Intervention Phase
Pain After Shoulder Surgery Drug: Variation in volume of local anesthetic Procedure: Ultrasound-guided interscalene brachial plexus block Phase 3

Study Type: Interventional
Study Design: 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?

Resource links provided by NLM:


Further study details as provided by Sunnybrook Health Sciences Centre:

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

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

Estimated Enrollment: 38
Study Start Date: July 2007
Study Completion Date: December 2007
  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

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

Exclusion Criteria:

  • Preexisting COPD
  • Unstable asthma
  • Psychiatric history
  • Allergy to ropivacaine.
  • Opioid tolerance (>30mg oral morphine or equivalent/day)
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00497354


Locations
Canada, Ontario
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M5N3M5
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Investigators
Principal Investigator: Colin JL McCartney, FRCA Sunnybrook Health Sciences Centre
  More Information

ClinicalTrials.gov Identifier: NCT00497354     History of Changes
Other Study ID Numbers: SHSCA01
First Submitted: July 3, 2007
First Posted: July 6, 2007
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:
Anesthetics
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents