Ultrasound Guidance for Interscalene Brachial Plexus Block

Nerve Block Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00702416
• Other study ID #: ANEST-ORT-01
• Status: Completed
• Phase: Phase 4
• First received: June 19, 2008
• Last updated: November 13, 2009
• Start date: May 2008
• Est. completion date: November 2009

Study information

• Verified date: November 2009
• Source: University of Parma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nerve Block
• Orthopedic Surgery
• Shoulder

Intervention

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.
• 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.

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
• Paracetamol
1 g iv q8h
• Morphine
5 mg im prn q1h (in the postoperative period)
• Fentanyl
50 µg iv prn (in the intraoperative period)

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.

Locations

Country	Name	City	State
Italy	University Hospital / Azienda Ospedaliero-Universitaria	Parma	PR

Sponsors (1)

Lead Sponsor	Collaborator
University of Parma

Country where clinical trial is conducted

Italy, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Onset time of brachial plexus anesthesia		=30 min	No
Secondary	Successful brachial plexus anesthesia		=30 min	No
Secondary	Additional analgesic requirements during surgery		Duration of surgery	No
Secondary	Incidence of paresthesiae during the anesthetic procedure		=30 min	Yes
Secondary	Incidence of blood aspiration during the anesthetic procedure		=30 min	Yes
Secondary	Number of needle redirections for the performance of the block		=30 min	No
Secondary	Pain during performance of the block		=30 min	No
Secondary	Pain at rest and on movement (visual analog scale)		q8h until 48 h after surgery	No
Secondary	Local anesthetic consumption on patient-controlled pump		=48 h	No