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Completed

NCT Number: NCT00702416

Ultrasound Guidance for Interscalene Brachial Plexus Block

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.

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Key information

Conditions

Shoulder Agnosia Nerve Block Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Orthopedic Surgery Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Postoperative Complications Signs and Symptoms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Hospital / Azienda Ospedaliero-Universitaria

Parma, PR, 43100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultrasound-guided continuous interscalene brachial plexus block

Procedure

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: Peripheral nerve block, Ultrasound, Regional anesthesia

Continuous interscalene brachial plexus block using electrical nerve stimulation

Procedure

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: Peripheral nerve block, Electrical nerve stimulation, Regional anesthesia

Ropivacaine

Drug

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

Paracetamol

Drug

1 g iv q8h

Other names: Acetaminophen, Perfalgan, Analgesic

Morphine

Drug

5 mg im prn q1h (in the postoperative period)

Other names: Opioid, Narcotic, Analgesic

Fentanyl

Drug

50 µg iv prn (in the intraoperative period)

Other names: Opioid, Narcotic, Analgesic

General Anesthesia

Procedure

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

Primary outcomes

  1. Onset time of brachial plexus anesthesia

    Time frame: ≤30 min

Secondary outcomes

  1. Successful brachial plexus anesthesia

    Time frame: ≤30 min

  2. Additional analgesic requirements during surgery

    Time frame: Duration of surgery

  3. Incidence of paresthesiae during the anesthetic procedure

    Time frame: ≤30 min

  4. Incidence of blood aspiration during the anesthetic procedure

    Time frame: ≤30 min

  5. Number of needle redirections for the performance of the block

    Time frame: ≤30 min

  6. Pain during performance of the block

    Time frame: ≤30 min

  7. Pain at rest and on movement (visual analog scale)

    Time frame: q8h until 48 h after surgery

  8. Local anesthetic consumption on patient-controlled pump

    Time frame: ≤48 h

Sponsors and collaborators

Lead sponsor

University of Parma

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jun 20, 2008
Registry last updated
Nov 16, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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