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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2014-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Shoulder Pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Local Anesthestic Dose

Group Type EXPERIMENTAL

Dose of of ropivacaine 0.75% used in block procedure

Intervention Type PROCEDURE

Interventions

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Dose of of ropivacaine 0.75% used in block procedure

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No