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

S

Sunnybrook Health Sciences Centre

Status and phase

Completed
Phase 3

Conditions

Pain After Shoulder Surgery

Treatments

Drug: Variation in volume of local anesthetic
Procedure: Ultrasound-guided interscalene brachial plexus block

Study type

Interventional

Funder types

Other

Identifiers

NCT00497354
SHSCA01

Details and patient eligibility

About

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.

Enrollment

38 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Double Blind

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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