Does a Low Volume Ultrasound-Guided Technique Reduce Common Complications of Interscalene Brachial Plexus Block?
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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? |
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| Canada, Ontario | |
| Sunnybrook Health Sciences Centre | |
| Toronto, Ontario, Canada, M5N3M5 | |
| 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 May 19, 2013