Ultrasound Guidance for Interscalene Brachial Plexus Block
NCT ID: NCT00702416
Last Updated: 2009-11-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
50 participants
INTERVENTIONAL
2008-05-31
2009-11-30
Brief Summary
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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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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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US Group
In this group, the continuous block will be performed under real-time ultrasound (US) guidance.
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.
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)
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
In this group, the continuous block will be performed with an electrical nerve stimulation (ENS) technique.
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.
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)
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.
Interventions
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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.
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)
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Elective surgery of the shoulder
* Informed consent to regional anesthesia
Exclusion Criteria
* 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
18 Years
85 Years
ALL
No
Sponsors
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University of Parma
OTHER
Responsible Party
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University of Parma
Principal Investigators
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Giorgio Danelli, MD
Role: PRINCIPAL_INVESTIGATOR
UO II Anestesia, Rianimazione e Terapia Antalgica, AOU Parma
Locations
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University Hospital / Azienda Ospedaliero-Universitaria
Parma, PR, Italy
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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ANEST-ORT-01
Identifier Type: -
Identifier Source: org_study_id
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