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

Pain After Shoulder Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00497354
• Other study ID #: SHSCA01
• Status: Completed
• Phase: Phase 3
• First received: July 3, 2007
• Last updated: June 14, 2010
• Start date: July 2007
• Est. completion date: December 2007

Study information

• Verified date: June 2010
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain After Shoulder Surgery

Intervention

Drug:
• Variation in volume of local anesthetic

Procedure:
• Ultrasound-guided interscalene brachial plexus block

Locations

Country	Name	City	State
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diaphragmatic paresis		30 minutes post block insertion
Secondary	Analgesic efficacy		30,60,90,120 minutes post surgery