Magnetic Resonance Imaging of Interscalene Plexus Block

July 9, 2014 updated by: Prof. Peter Gerner, M.D., Paracelsus Medical University

Magnetic Resonance Imaging of Local Anesthetic Distribution: A Comparison of 5 and 15 Milliliters of Ropivacaine 0,75% for Ultrasound Guided Interscalene Plexus Blockade

Interscalene plexus block is a widely used technique to provide anesthesia and analgesia for surgery at the upper extremity (shoulder and upper arm); it is standard-of-care in many institutions worldwide. Local anesthetic is being injected around the nerves supplying the arm (Plexus brachialis) at a specific location in the arm (between the scalenus muscles, thus called "interscalene plexus block"). The optimal volume of injection with regard to efficacy, safety and avoidance of untoward effects has been subject to intense debate for a long time. In spite of evidence that small volumes (between 5 and 7 mls) are effective for adequate postoperative analgesia, larger volumes up to 40 mls are still frequently used in many practices. However, with the use of such large doses, adverse events are known to occur with increased frequency, including paralysis of the diaphragm or spread of local anesthetic to the spinal cord.

This study is intended to help evaluate the effects of small or larger injection of local anesthetic around the brachial plexus, and to correlate the distribution with clinical efficacy, block duration, and possible side effects. It is a randomized, controlled, observer-blinded trial; patients undergoing shoulder or upper arm surgery will be randomly allocated to receive either 5mls or 20mls of local anesthetic for their interscalene plexus block. Magnetic resonance imaging will be performed immediately afterwards, followed by a series of neurological exams during the hospital stay. Test of lung function (spirometry) and ultrasound of the diaphragm will be used to evaluate effects of the block on respiratory mechanics.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background: Interscalene plexus blockade (ISB) is frequently used during surgery of the upper limb. The use of ultrasound has significantly reduced time of onset and total volume of local anesthetics in comparison to nerve localization by stimulators. (1-4) The introduction of this technique has been correlated with decreased volumes of effective local anesthetics from 40 milliliters and more down to 10 milliliters and less.(3-4) As the injection site of ISB is located in close proximity to the anatomical structures of the spinal cord, spread of local anesthetics could potentially cause adverse events, including contralateral blockade and total spinal anesthesia. Case reports on these complications have been published previously. (5-11)In a recently published study we showed that the phenomenon of epidural spread can be reproduced in cadavers and seems to be positively correlated to injection-volumes exceeding 10 milliliters.(12) Moreover, we observed a trend towards cranial spread of the contrast agent in all investigated specimens along the course of the nerval roots towards the spinal cord. In another cadaveric study by Orebauch et al., cranial epidural spread was also detectable following injection of dye into the nerval roots of the brachial plexus.(13) Magnetic resonance imaging has not yet been used for visualization of the spread of local anaesthetics in ISB.

Given that ultrasound provides excellent visualization of target-structures in regional anesthesia and therefore enables physicians to place injection needles with enormous accuracy, the question arises whether there is a critical volume for local anesthetics increasing complications such as epidural spread and in consequence contralateral blockade.

The aim of this study is to confirm the findings of our cadaveric study in vivo and to show that the frequency of epidural spread correlates with injection of increased volumes of local anesthetics.

Primary endpoint: Spread of local anesthetics to the epidural space

Secondary endpoints:

  • Contralateral epidural spread.
  • Spread of local anesthetics to the phrenic nerve.
  • Bed side spirometry and ultrasound investigation of the diaphragm in the PACU.
  • Oxygen saturation in the PACU
  • Self-reported block duration.
  • Self reported pain scores for the first 24 postoperative hours
  • Time to first analgesic consumption on demand.
  • Total analgesic consumption (ropivacaine PCA).

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Salzburg, Austria, 5020
        • Paracelsus Medical University, Department of Anesthesiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age between 18 and 75 years
  • Surgery of the shoulder (shoulder arthroscopy, open shoulder joint surgery, rotator cuff surgery, tendon transfer, shoulder arthroplasty, humerus fracture surgery)
  • Patients willing to undergo magnetic resonance imaging prior to surgery
  • Informed consent to participate in the study
  • American Society of Anesthesiologists physical score I, II or III

Exclusion Criteria:

  • Refusal to participate in the study
  • Inability to understand the study protocol due to language barrier
  • Serious cardiac or pulmonary disease such as decompensated heart failure, recent myocardial infarction (less than one month in the past), heart block greater than 2nd degree, obstructive sleep apnea and chronic obstructive lung disease greater than 2nd degree
  • renal impairment with an calculated glomerular filtration rate below 60ml/min
  • Hypersensitivity to ropivacaine or gadolinium or other contraindications against peripheral nerve blocks
  • Chronic opioid usage greater than 15 mg oral morphine equivalents daily, the daily use of adjunctive pain medications (gabapentins, tricyclic antidepressants, serotonin-norepinephrine reuptake inhibitors)
  • Schizophrenia or bipolar disorders, uncontrolled anxiety, claustrophobia
  • Peripheral neuropathy
  • Hepatic or renal impairment
  • Ongoing illicit drug or alcohol abuse
  • Metal implants or other contraindications for magnetic resonance imaging
  • Coagulopathy
  • Participation in additional clinical trials within 4 weeks before screening
  • Hearing impairment
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Interscalene Nerve Block - 5ml

ultrasound guided interscalene plexus block (UISB)

Ropivacaine 0.75%, 20ml Gadopentetate-Dimeglumine 0.05 mmol Shoulder Surgery
Procedure: Interscalene Nerve Block
ultrasound guided interscalene plexus block (UISB) immediately before magnetic resonance imaging of the neck.
Drug: Gadopentetate-Dimeglumine 0.0125 mmol
0.0125 mmol of gadopentetate-dimeglumine
Other Names:
  • Magnevist
Drug: Ropivacaine 0.75%, 5ml
5 ml of ropivacaine 0.75%
Other Names:
  • Naropin
Procedure: Shoulder Surgery
As per individual requirement (patient-dependent)
ACTIVE_COMPARATOR: Interscalene Nerve Block - 20ml

ultrasound guided interscalene plexus block (UISB)

Ropivacaine 0.75%, 5ml Gadopentetate-Dimeglumine 0.0125 mmol Shoulder Surgery
Procedure: Interscalene Nerve Block
ultrasound guided interscalene plexus block (UISB) immediately before magnetic resonance imaging of the neck.
Procedure: Shoulder Surgery
As per individual requirement (patient-dependent)
Drug: Ropivacaine 0.75%, 20ml
20 ml of ropivacaine 0.75%
Other Names:
  • Naropin
Drug: Gadopentetate-Dimeglumine 0.05 mmol
0.05 mmol of gadopentetate-dimeglumine
Other Names:
  • Magnevist

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Spread of local anesthetics to the epidural space
Time Frame: 10 minutes
Spread of local anesthetics to the epidural space, as seen in the magnetic resonance imaging
10 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Contralateral epidural spread
Time Frame: 10 min
as seen on MRI
10 min
Spread of local anesthetics to the phrenic nerve
Time Frame: 10 minutes
as seen on MRI
10 minutes
Bed side spirometry and ultrasound investigation of the diaphragm in the PACU
Time Frame: 24 hours
24 hours
Oxygen saturation in the PACU
Time Frame: 2-6 hours
2-6 hours
Self-reported block duration
Time Frame: 24 hours
24 hours
Self reported pain scores for the first 24 postoperative hours
Time Frame: 24 hrs
24 hrs
Time to first analgesic consumption on demand
Time Frame: 24 hours
24 hours
Total analgesic consumption (ropivacaine PCA).
Time Frame: 24 hours
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Paracelsus Medical University

Investigators

  • Study Chair: Peter Gerner, MD, Department of Anesthesiology, Perioperative Medicine and Intensive Care, Paracelsus Medical University, Salzburg, Austria
  • Principal Investigator: Gerhard Fritsch, MD, Department of Anesthesiology, Perioperative Medicine and Intensive Care, Paracelsus Medical University, Salzburg, Austria

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (ACTUAL)

July 1, 2014

Study Completion (ACTUAL)

July 1, 2014

Study Registration Dates

First Submitted

April 17, 2014

First Submitted That Met QC Criteria

June 24, 2014

First Posted (ESTIMATE)

June 26, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

July 10, 2014

Last Update Submitted That Met QC Criteria

July 9, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MR-ISB-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Disorder of Shoulder

Clinical Trials on Interscalene Nerve Block

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Sri Lanka

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe