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

NCT00497354 | Completed Phase 3

• 1 other identifier: SHSCA01
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain After Shoulder Surgery

Keywords

Ultrasound, Complications, Regional Anesthesia

Outcome Measures

Primary Outcomes (1)

• Diaphragmatic paresis

  30 minutes post block insertion

Secondary Outcomes (1)

• Analgesic efficacy

  30,60,90,120 minutes post surgery

Interventions

Variation in volume of local anesthetic DRUG

Ultrasound-guided interscalene brachial plexus block PROCEDURE

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Preexisting COPD
• Unstable asthma
• Psychiatric history
• Allergy to ropivacaine.
• Opioid tolerance (\>30mg oral morphine or equivalent/day)

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M5N3M5, Canada

Location

Study Officials

• Colin JL McCartney, FRCA

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 3, 2007
• First Posted: July 6, 2007
• Study Start: July 1, 2007
• Study Completion: December 1, 2007
• Last Updated: June 15, 2010

Record last verified: 2010-06

Locations

CA (1)