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

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00497354
Enrollment
38
Registered
2007-07-06
Start date
2007-07-31
Completion date
2007-12-31
Last updated
2010-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain After Shoulder Surgery

Keywords

Ultrasound, Complications, Regional Anesthesia

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.

Interventions

DRUGVariation in volume of local anesthetic

Sponsors

Sunnybrook Health Sciences Centre
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
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)

Design outcomes

Primary

MeasureTime frame
Diaphragmatic paresis30 minutes post block insertion

Secondary

MeasureTime frame
Analgesic efficacy30,60,90,120 minutes post surgery

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026