Determining the Minimal Effective Volume (MEAV95) for Interscalene Brachial Plexus Block for Surgical Anesthesia

NCT01703130 | Unknown Phase 4 DMC

• 1 other identifier: 126-2012
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Interscalene block (ISB) consistently demonstrates superior pain relief after shoulder surgery. However, patients can experience complications such as blurred vision, hoarseness and shortness of breath with the standard volumes of local anesthetic used in contemporary practice. Patients with respiratory diseases are precluded because of the potential effects on respiration. However, they are then exposed to the risks of general anesthesia and opioid medications which can also have detrimental effects on respiration. Ultrasound guided ISB can reduce the local anesthetic volume required to produce anesthesia for shoulder surgery; this may reduce the complications from ISB to allow patients previously unable to benefit to have this technique, such as patients with obesity and respiratory disease. In order to do so the investigators will use an up-down methodology to find the minimum volume of local anesthetic to provide sufficient anesthesia for shoulder surgery.

Conditions

Shoulder Pain

Keywords

ISPB; Brachial Plexus Block; Anesthesia; Pain Management; Surgery

Outcome Measures

Primary Outcomes (1)

• MEAV95 of ropivacaine 0.75%

  to determine the MEAV95 of ropivacaine 0.75% at the level of root C5-6 using the dose-finding protocol. The success of surgical anesthesia is defined by the presence of sensory blockade (no sensation/score of 0 to pinprick testing) 30 minutes post injection of local anesthetic

  30 minutes post injection

Secondary Outcomes (8)

• Motor blockade

  30 minutes

• Bedside spirometry

  30 minutes post block, 30min post-surgery, and 2 hours post surgery

• Diaphragmatic excursion

  30 minutes post block, and 2 hours post surgery

• Complications

  30 minutes

• Pain Scores on Visual Analog Scale

  at baseline, after surgery at 30 and 60 minutes in the PACU, and at 1 hour intervals until discharge

Study Arms (1)

Local Anesthestic Dose

EXPERIMENTAL

Procedure: Dose of of ropivacaine 0.75% used in block procedure

Interventions

Dose of of ropivacaine 0.75% used in block procedure PROCEDURE

Local Anesthestic Dose

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing elective arthroscopic shoulder surgery in the sitting position
• Patients aged \>=18 and \<=75 years
• ASA I-III

You may not qualify if:

• Patient refusal for surgery under ISBPB with sedation
• Lack of capacity to provide informed consent
• Pre-existing COPD, unstable asthma or diaphragmatic dysfunction
• Coagulopathy
• Infection at injection site
• Allergy to local anesthetics
• Opioid tolerance (\>30mg oral morphine or equivalent/day for \>1 week)
• BMI\>40
• Inability to complete questionnaires and assessments (consent, follow-up phone call) due to language barrier
• Pregnancy or lactation

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead
• The Physicians' Services Incorporated Foundation: collaborator

Study Sites (1)

Sunnybrook Health Sciences Centre - Holland Orthopaedic and Arthritic Centre

Toronto, Ontario, M4Y 1H1, Canada

RECRUITING

Related Links

• Facility website

MeSH Terms

Conditions

Shoulder Pain; Agnosia

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Colin McCartney

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

• Stephen Choi

  Sunnybrook Health Sciences Centre

  STUDY CHAIR

• Jane Wang

  Sunnybrook Health Sciences Centre

  STUDY CHAIR

• Moein Tavakkoli Zadeh

  Sunnybrook Health Sciences Centre

  STUDY CHAIR

Central Study Contacts

Colin McCartney

CONTACT

(416) 480-6100; colin.mccartney@sunnybrook.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Anesthesiologist and Director of Research

Study Record Dates

• First Submitted: October 4, 2012
• First Posted: October 10, 2012
• Study Start: October 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: June 2, 2014

Record last verified: 2014-05

Locations

CA (1)