Ultrasound Guidance for Interscalene Brachial Plexus Block

NCT00702416 | Completed Phase 4

• 1 other identifier: ANEST-ORT-01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Shoulder; Orthopedic Surgery; Nerve Block

Keywords

Analgesia, Patient-controlled; Anesthesia, Regional; Ultrasound; Postoperative Pain; Brachial Plexus

Outcome Measures

Primary Outcomes (1)

• Onset time of brachial plexus anesthesia

  ≤30 min

Secondary Outcomes (8)

• Successful brachial plexus anesthesia

  ≤30 min

• Additional analgesic requirements during surgery

  Duration of surgery

• Incidence of paresthesiae during the anesthetic procedure

  ≤30 min

• Incidence of blood aspiration during the anesthetic procedure

  ≤30 min

• Number of needle redirections for the performance of the block

  ≤30 min

Study Arms (2)

US Group

EXPERIMENTAL

In this group, the continuous block will be performed under real-time ultrasound (US) guidance.

Procedure: Ultrasound-guided continuous interscalene brachial plexus block; Drug: Ropivacaine; Drug: Paracetamol; Drug: Morphine; Drug: Fentanyl; Procedure: General anesthesia

ENS Group

ACTIVE COMPARATOR

In this group, the continuous block will be performed with an electrical nerve stimulation (ENS) technique.

Procedure: Continuous interscalene brachial plexus block using electrical nerve stimulation; Drug: Ropivacaine; Drug: Paracetamol; Drug: Morphine; Drug: Fentanyl; Procedure: General anesthesia

Interventions

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.

Also known as: Peripheral nerve block, Ultrasound, Regional anesthesia

US Group

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.

Also known as: Peripheral nerve block, Electrical nerve stimulation, Regional anesthesia

ENS Group

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

Also known as: Naropin, Local anesthetic, Amide local anesthetic

ENS Group; US Group

Paracetamol DRUG

1 g iv q8h

Also known as: Acetaminophen, Perfalgan, Analgesic

ENS Group; US Group

Morphine DRUG

5 mg im prn q1h (in the postoperative period)

Also known as: Opioid, Narcotic, Analgesic

ENS Group; US Group

Fentanyl DRUG

50 µg iv prn (in the intraoperative period)

Also known as: Opioid, Narcotic, Analgesic

ENS Group; US Group

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.

Also known as: Monitored anesthesia care

ENS Group; US Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Parma: lead

Study Sites (1)

University Hospital / Azienda Ospedaliero-Universitaria

Parma, PR, 43100, Italy

Location

Related Publications (4)

• Casati A, Fanelli G, Aldegheri G, Berti M, Colnaghi E, Cedrati V, Torri G. Interscalene brachial plexus anaesthesia with 0.5%, 0.75% or 1% ropivacaine: a double-blind comparison with 2% mepivacaine. Br J Anaesth. 1999 Dec;83(6):872-5. doi: 10.1093/bja/83.6.872.

  PMID: 10700785 BACKGROUND

• Stevens MF, Werdehausen R, Golla E, Braun S, Hermanns H, Ilg A, Willers R, Lipfert P. Does interscalene catheter placement with stimulating catheters improve postoperative pain or functional outcome after shoulder surgery? A prospective, randomized and double-blinded trial. Anesth Analg. 2007 Feb;104(2):442-7. doi: 10.1213/01.ane.0000253513.15336.25.

  PMID: 17242107 BACKGROUND

• Casati A, Borghi B, Fanelli G, Montone N, Rotini R, Fraschini G, Vinciguerra F, Torri G, Chelly J. Interscalene brachial plexus anesthesia and analgesia for open shoulder surgery: a randomized, double-blinded comparison between levobupivacaine and ropivacaine. Anesth Analg. 2003 Jan;96(1):253-9, table of contents. doi: 10.1097/00000539-200301000-00051.

  PMID: 12505962 BACKGROUND

• Casati A, Danelli G, Baciarello M, Corradi M, Leone S, Di Cianni S, Fanelli G. A prospective, randomized comparison between ultrasound and nerve stimulation guidance for multiple injection axillary brachial plexus block. Anesthesiology. 2007 May;106(5):992-6. doi: 10.1097/01.anes.0000265159.55179.e1.

  PMID: 17457131 BACKGROUND

MeSH Terms

Conditions

Agnosia; Pain, Postoperative

Interventions

High-Energy Shock Waves; Anesthesia, Conduction; Transcutaneous Electric Nerve Stimulation; Ropivacaine; Anesthetics, Local; Acetaminophen; Analgesics; Morphine; Analgesics, Opioid; Narcotics; Fentanyl; Anesthesia, General

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena; Anesthesia; Anesthesia and Analgesia; Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses; Acetanilides; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Piperidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Giorgio Danelli, MD

  UO II Anestesia, Rianimazione e Terapia Antalgica, AOU Parma

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 19, 2008
• First Posted: June 20, 2008
• Study Start: May 1, 2008
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: November 16, 2009

Record last verified: 2009-11

Locations

IT (1)