Effects of Technique on the Local Anesthetic Dose Required for Interscalene Brachial Plexus Block

Effects of Ultrasound Guidance on the Minimum Effective Anesthetic Volume Required for Interscalene Brachial Plexus Block Versus Nerve Stimulator Guidance

Interscalene brachial plexus block (ISBPB) is a common nerve block given to patients who are undergoing shoulder surgery. This block has a low, but still significant, rate of complications. Reducing the volume of local anesthetic given during the block may allow some of these complications to be avoided. Participants will be randomly assigned to a group to undergo ISBPB under ultrasound or nerve stimulator guidance. Each group will initially receive 10mL of local anesthetic. The volume used for each subsequent patient depends upon the success or failure of the previous patient's block - a failure will cause the volume given to increase by 2.5mL, while a success will cause the volume to decrease by the same amount. We hypothesize that the minimum effective anesthetic volume in 50% of patients will be significantly lower in the ultrasound guided group than in the nerve stimulator group. We further hypothesize that this lower volume will lead to a decreased rate of complications.

Study Overview

• Status: Unknown
• Conditions: Arthroscopic Shoulder Surgery
• Intervention / Treatment: Other: Ultrasound Minimum Effective Anesthetic Volume; Other: Nerve Stimulator Minimum Effective Anesthetic Volume

Detailed Description

This will be a randomized, single-blind, up-down sequential allocation study. Patients will be randomly assigned to one of two groups, and receive either an ultrasound-guided or nerve-stimulator guided interscalene brachial plexus block. The initial local anesthetic volume in both groups will be 10mL. The outcome of each patient's block will determine the dose for the subsequent patient. When an effective ISBPB is observed, as defined by a NRS (patient-rated pain on a scale from 0 to 10) rating of 0 within 30 minutes post-surgery, the volume of local anesthetic solution used for the next patient will be decreased by 2.5mL. Conversely, when an ineffective ISBPB is observed, the volume of local anesthetic used for the next patient will be increased by 2.5mL.

The goal of this study is to determine the minimum effective anesthetic volume of ropivacaine 0.5% providing analgesia in patients when using either ultrasound or a nerve stimulator to guide placement of the block. The primary outcome measure will be the pain score of the patient on a numeric rating score during the 30 minutes after surgery.

A number of previous studies have suggested that ultrasound-guidance is beneficial for peripheral nerve blocks in terms of block performance time, success rates, and block quality. Some studies have also shown that ultrasound-guidance can reduce the volume of local anesthetic needed to perform a successful block. This study may reveal that less local anesthetic is needed under ultrasound guidance than under nerve stimulator, which may potentially reduce some of the common complications of ISBPB.

We hypothesize that ISBPB done under ultrasound guidance will have a lower minimum effective local anesthetic volume than ISBPB done under nerve stimulation. Further, we hypothesize that the lower volume will reduce the incidence of some of the complications of ISBPB.

Using lower volumes of local anesthetic while still maintaining effective analgesia may reduce some of the common complications of ISBPB. It may also allow this beneficial analgesic technique to be given to patients with some respiratory risk factors who are currently unable to receive it.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M4N 3M5
      • Recruiting
      • Sunnybrook Health Sciences Centre
      • Contact: Colin J McCartney, MD; Phone Number: 3230 416-480-6100; Email: cjlmccartney@sympatico.ca
      • Principal Investigator: Colin J McCartney, MD
      • Sub-Investigator: Andrew McNaught, MD
      • Sub-Investigator: Uma D Shastri, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients receiving interscalene brachial plexus block for arthroscopic shoulder surgery

Exclusion Criteria:

• ASA >III, and body mass index (BMI) >35, pre-existing chronic obstructive pulmonary disease (COPD), unstable asthma, psychiatric history, renal or hepatic impairment, allergy to ropivacaine, and opioid tolerance (>30 mg oral morphine or equivalent per day).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1 - Ultrasound; Participants will receive an ultrasound guided interscalene brachial plexus block	Other: Ultrasound Minimum Effective Anesthetic Volume; Each sequential participant in this group will be assigned a dose based on the success or failure of the previous participant's block. The starting dose will be 10mL of 0.5% ropivacaine. Each success will decrease the dose by 2.5mL and each failure will subsequently increase the dose by 2.5mL.
Active Comparator: 2 - Nerve Stimulator; Participants will receive a nerve stimulator guided interscalene brachial plexus block	Other: Nerve Stimulator Minimum Effective Anesthetic Volume; Each sequential participant in this group will be assigned a dose based on the success or failure of the previous participant's block. The starting dose will be 10mL of 0.5% ropivacaine. Each success will decrease the dose by 2.5mL and each failure will subsequently increase the dose by 2.5mL.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pain Rating as based on 11 point NRS scale	within 30 minutes or less post-surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
Diaphragmatic Function (as assessed by diaphragmatic movement on ultrasound)	within 30 minutes post-block

Collaborators and Investigators

• Sponsor: Sunnybrook Health Sciences Centre
• Investigators: Principal Investigator: Colin J McCartney, MD, Sunnybrook Health Sciences Centre

Study record dates

Study Major Dates

• Study Start: August 1, 2008
• Primary Completion (Anticipated): February 1, 2009
• Study Completion (Anticipated): July 1, 2009

Study Registration Dates

• First Submitted: August 5, 2008
• First Submitted That Met QC Criteria: August 5, 2008
• First Posted (Estimate): August 8, 2008

Study Record Updates

• Last Update Posted (Estimate): August 8, 2008
• Last Update Submitted That Met QC Criteria: August 5, 2008
• Last Verified: August 1, 2008

More Information

Terms related to this study

• Keywords: Regional Anesthesia; Interscalene Brachial Plexus Block; Ultrasound guided peripheral nerve block; Minimum Effective Anesthetic Volume; Nerve Stimulator guided peripheral nerve block
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: SHSCA02