Ultrasound Guidance for Interscalene Brachial Plexus Block

November 13, 2009 updated by: University of Parma

Ultrasound Guidance or Electrical Nerve Stimulation for Interscalene Brachial Plexus Block: a Randomized, Controlled Trial

This study has been designed to assess the possible advantages of using ultrasound imaging to block the brachial plexus (i.e., nerves of the upper limb) in patients undergoing shoulder surgery.

The ultrasound technique will be compared with the current gold standard, electrical nerve stimulation.

The aim of this study is to define which technique is better in terms of time to onset of anesthesia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study will compare real-time ultrasound (US) guidance and electrical nerve stimulation (ENS) in terms of onset time for interscalene brachial plexus anesthesia.

The main hypothesis is that direct visualization of neural structures under US guidance will grant better local anesthetic (LA) disposition around the roots of the plexus, thus improving onset times.

Perineural catheters will be used to maintain regional analgesia for 48 hours after surgery. We hypothesize that US guidance may also help physicians place perineural catheters more precisely, thus improving analgesia in the following hours to days.

Finally, we will investigate for possible differences in minor adverse events such as vascular puncture, pain during the anesthetic procedure.

Study Type

Interventional

Enrollment (Anticipated)

50

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

  • Italy
    • PR
      • Parma, PR, Italy, 43100
        • University Hospital / Azienda Ospedaliero-Universitaria

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

14 years to 81 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ASA Physical Status Class I-III
  • Elective surgery of the shoulder
  • Informed consent to regional anesthesia

Exclusion Criteria:

  • Inability to effectively communicate
  • Chronic opioid use
  • Absence of informed consent to participation to the study
  • Ipsilateral upper limb neurological deficits
  • Known allergy to study medications
  • Contraindications to continuous block placement

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 Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: US Group
In this group, the continuous block will be performed under real-time ultrasound (US) guidance.
Procedure: Ultrasound-guided continuous interscalene brachial plexus block

With patients in the supine position, a high-frequency (10-12 MHz) ultrasound transducer in a sterile sheath will be applied to explore the interscalene region and locate the brachial plexus. The transducer will be positioned so as to image the C5 and C6 roots in a single view. Visualization of the C7 root in the same scan will be sought, but will not be required.

A 50-mm, 20 G needle will be advanced in-plane from the postero-lateral side of the transducer. Injection of the local anesthetic will be performed in small aliquots while repositioning of the needle in order to optimize spread of the injectate around the nerve roots.

At the end of the injection, a catheter will be threaded through the needle. The catheter will be positioned to lie deep and close to the imaged nerve roots.

Other Names:
  • Ultrasound
  • Regional anesthesia
  • Peripheral nerve block
Drug: Ropivacaine

Block induction [1% (wt/vol) solution]:

20 ml (200 mg)

Postoperative analgesia [0.2% (wt/vol) solution]:

  • Background infusion: 4 ml/h (8 mg/h)
  • Incremental on-demand dose: 2 ml (4 mg)
  • Lockout time: 15 min
Other Names:
  • Naropin
  • Local anesthetic
  • Amide local anesthetic
Drug: Paracetamol
1 g iv q8h
Other Names:
  • Perfalgan
  • Acetaminophen
  • Analgesic
Drug: Morphine
5 mg im prn q1h (in the postoperative period)
Other Names:
  • Narcotic
  • Opioid
  • Analgesic
Drug: Fentanyl
50 µg iv prn (in the intraoperative period)
Other Names:
  • Narcotic
  • Opioid
  • Analgesic
Procedure: General anesthesia

Will be given in case of block failure and/or patient discomfort intractable with fentanyl during the procedure.

The technique will be left at the discretion of the attending anesthesiologist. Monitored anesthesia care will also be acceptable; the block will be considered as failed in that case as well.

Other Names:
  • Monitored anesthesia care
Active Comparator: ENS Group
In this group, the continuous block will be performed with an electrical nerve stimulation (ENS) technique.
Drug: Ropivacaine

Block induction [1% (wt/vol) solution]:

20 ml (200 mg)

Postoperative analgesia [0.2% (wt/vol) solution]:

  • Background infusion: 4 ml/h (8 mg/h)
  • Incremental on-demand dose: 2 ml (4 mg)
  • Lockout time: 15 min
Other Names:
  • Naropin
  • Local anesthetic
  • Amide local anesthetic
Drug: Paracetamol
1 g iv q8h
Other Names:
  • Perfalgan
  • Acetaminophen
  • Analgesic
Drug: Morphine
5 mg im prn q1h (in the postoperative period)
Other Names:
  • Narcotic
  • Opioid
  • Analgesic
Drug: Fentanyl
50 µg iv prn (in the intraoperative period)
Other Names:
  • Narcotic
  • Opioid
  • Analgesic
Procedure: General anesthesia

Will be given in case of block failure and/or patient discomfort intractable with fentanyl during the procedure.

The technique will be left at the discretion of the attending anesthesiologist. Monitored anesthesia care will also be acceptable; the block will be considered as failed in that case as well.

Other Names:
  • Monitored anesthesia care
Procedure: Continuous interscalene brachial plexus block using electrical nerve stimulation

With patients in the supine position, the head will be rotated to the contralateral side. The interscalene groove will be palpated.

A 35-mm, 20 G needle will be inserted at the estimated C6 level (cricoid cartilage) with a 30-45° angle to the skin. The needle will be advanced along a line joining the insertion site to the axilla.

An electrical nerve stimulator will be used at an initial intensity of 1.0 mA (frequency: 2 Hz, pulse width: 0.2 ms). A musculocutaneous or axillary-nerve mediated twitch will be sought

Injection of the local anesthetic will start with a visible motor response at a current <0.5 mA. The catheter will be positioned to as to elicit a motor response at ≤0.4 mA.

Other Names:
  • Regional anesthesia
  • Peripheral nerve block
  • Electrical nerve stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Onset time of brachial plexus anesthesia
Time Frame: ≤30 min
≤30 min

Secondary Outcome Measures

Outcome Measure
Time Frame
Successful brachial plexus anesthesia
Time Frame: ≤30 min
≤30 min
Additional analgesic requirements during surgery
Time Frame: Duration of surgery
Duration of surgery
Incidence of paresthesiae during the anesthetic procedure
Time Frame: ≤30 min
≤30 min
Incidence of blood aspiration during the anesthetic procedure
Time Frame: ≤30 min
≤30 min
Number of needle redirections for the performance of the block
Time Frame: ≤30 min
≤30 min
Pain during performance of the block
Time Frame: ≤30 min
≤30 min
Pain at rest and on movement (visual analog scale)
Time Frame: q8h until 48 h after surgery
q8h until 48 h after surgery
Local anesthetic consumption on patient-controlled pump
Time Frame: ≤48 h
≤48 h

Collaborators and Investigators

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

Sponsor

University of Parma

Investigators

  • Principal Investigator: Giorgio Danelli, MD, UO II Anestesia, Rianimazione e Terapia Antalgica, AOU Parma

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

May 1, 2008

Primary Completion (Actual)

November 1, 2009

Study Completion (Actual)

November 1, 2009

Study Registration Dates

First Submitted

June 19, 2008

First Submitted That Met QC Criteria

June 19, 2008

First Posted (Estimate)

June 20, 2008

Study Record Updates

Last Update Posted (Estimate)

November 16, 2009

Last Update Submitted That Met QC Criteria

November 13, 2009

Last Verified

November 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANEST-ORT-01

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.

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