Ultrasound Guidance for Interscalene Brachial Plexus Block - Full Text View

Sponsored by:	University of Parma
Information provided by:	University of Parma
ClinicalTrials.gov Identifier:	NCT00702416

Purpose

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.

Condition	Intervention	Phase
Shoulder Orthopedic Surgery Nerve Block	Procedure: Ultrasound-guided continuous interscalene brachial plexus block Procedure: Continuous interscalene brachial plexus block using electrical nerve stimulation Drug: Ropivacaine Drug: Paracetamol Drug: Morphine Drug: Fentanyl Procedure: General anesthesia	Phase IV

MedlinePlus related topics: Anesthesia Ultrasound

Drug Information available for: Fentanyl Citrate Fentanyl Ropivacaine Ropivacaine Hydrochloride Ropivacaine monohydrochloride Acetaminophen

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Ultrasound Guidance or Electrical Nerve Stimulation for Interscalene Brachial Plexus Block: a Randomized, Controlled Trial

Further study details as provided by University of Parma:

Primary Outcome Measures:

Onset time of brachial plexus anesthesia [ Time Frame: ≤30 min ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Successful brachial plexus anesthesia [ Time Frame: ≤30 min ] [ Designated as safety issue: No ]
Additional analgesic requirements during surgery [ Time Frame: Duration of surgery ] [ Designated as safety issue: No ]
Incidence of paresthesiae during the anesthetic procedure [ Time Frame: ≤30 min ] [ Designated as safety issue: Yes ]
Incidence of blood aspiration during the anesthetic procedure [ Time Frame: ≤30 min ] [ Designated as safety issue: Yes ]
Number of needle redirections for the performance of the block [ Time Frame: ≤30 min ] [ Designated as safety issue: No ]
Pain during performance of the block [ Time Frame: ≤30 min ] [ Designated as safety issue: No ]
Pain at rest and on movement (visual analog scale) [ Time Frame: q8h until 48 h after surgery ] [ Designated as safety issue: No ]
Local anesthetic consumption on patient-controlled pump [ Time Frame: ≤48 h ] [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	May 2008
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 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. 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 Drug: Paracetamol 1 g iv q8h Drug: Morphine 5 mg im prn q1h (in the postoperative period) Drug: 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.
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 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 Drug: Paracetamol 1 g iv q8h Drug: Morphine 5 mg im prn q1h (in the postoperative period) Drug: 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.

Arms

Assigned Interventions

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

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.

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

Drug: Paracetamol

1 g iv q8h

Drug: Morphine

5 mg im prn q1h (in the postoperative period)

Drug: 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.

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

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

Drug: Paracetamol

1 g iv q8h

Drug: Morphine

5 mg im prn q1h (in the postoperative period)

Drug: 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.

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.

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00702416

Contacts

Contact: Giorgio Danelli, MD

+39-052-170-3515

gdanelli@ao.pr.it

Locations

Italy, PR
University Hospital / Azienda Ospedaliero-Universitaria	Recruiting
Parma, PR, Italy, 43100
Contact: Guido Fanelli, MD +39-052-170-3567 guido.fanelli@unipr.it
Contact: Giorgio Danelli, MD +39-052-170-3515 gdanelli@ao.pr.it
Principal Investigator: Giorgio Danelli, MD
Sub-Investigator: Alessandro Dallospedale
Sub-Investigator: Alessandra Markidis, MD

Sponsors and Collaborators

University of Parma

Investigators

Principal Investigator:

Giorgio Danelli, MD

UO II Anestesia, Rianimazione e Terapia Antalgica, AOU Parma

More Information

Publications:

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.

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.

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.

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.

Responsible Party:	University of Parma ( Guido Fanelli, MD )
Study ID Numbers:	ANEST-ORT-01
Study First Received:	June 19, 2008
Last Updated:	July 25, 2008
ClinicalTrials.gov Identifier:	NCT00702416
Health Authority:	Italy: Ethics Committee

Keywords provided by University of Parma:

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

Study placed in the following topic categories:

Morphine
Fentanyl
Ropivacaine

Pain
Acetaminophen
Pain, Postoperative

Additional relevant MeSH terms:

Anesthetics, Intravenous
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Narcotics
Anesthetics, Local
Pharmacologic Actions
Adjuvants, Anesthesia

Analgesics, Non-Narcotic
Sensory System Agents
Anesthetics, General
Therapeutic Uses
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on January 15, 2009