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

This study has been completed.
Sponsor:
Information provided by:
Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT00497354
First received: July 3, 2007
Last updated: June 14, 2010
Last verified: June 2010
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Does a Low Volume Ultrasound-Guided Technique Reduce Common Complications of Interscalene Brachial Plexus Block?

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00497354     History of Changes
Other Study ID Numbers: SHSCA01
Study First Received: July 3, 2007
Last Updated: June 14, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Sunnybrook Health Sciences Centre:
Ultrasound, Complications, Regional Anesthesia

Additional relevant MeSH terms:
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 July 29, 2014