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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| US Group | Experimental | In this group, the continuous block will be performed under real-time ultrasound (US) guidance. |
|
| ENS Group | Active Comparator | In this group, the continuous block will be performed with an electrical nerve stimulation (ENS) technique. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Onset time of brachial plexus anesthesia | ≤30 min |
| Measure | Description | Time Frame |
|---|---|---|
| Successful brachial plexus anesthesia | ≤30 min | |
| Additional analgesic requirements during surgery | Duration of surgery | |
| Incidence of paresthesiae during the anesthetic procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Giorgio Danelli, MD | UO II Anestesia, Rianimazione e Terapia Antalgica, AOU Parma | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital / Azienda Ospedaliero-Universitaria | Parma | PR | 43100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10700785 | Background | 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. | |
| 17242107 | 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. |
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| 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. |
|
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| Ropivacaine | Drug | Block induction [1% (wt/vol) solution]: 20 ml (200 mg) Postoperative analgesia [0.2% (wt/vol) solution]:
|
|
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| Paracetamol | Drug | 1 g iv q8h |
|
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| Morphine | Drug | 5 mg im prn q1h (in the postoperative period) |
|
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| Fentanyl | Drug | 50 µg iv prn (in the intraoperative period) |
|
|
| 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. |
|
|
| ≤30 min |
| Incidence of blood aspiration during the anesthetic procedure | ≤30 min |
| Number of needle redirections for the performance of the block | ≤30 min |
| Pain during performance of the block | ≤30 min |
| Pain at rest and on movement (visual analog scale) | q8h until 48 h after surgery |
| Local anesthetic consumption on patient-controlled pump | ≤48 h |
| 12505962 | 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. |
| 17457131 | 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. |
| ID | Term |
|---|---|
| D000377 | Agnosia |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D019220 | High-Energy Shock Waves |
| D000765 | Anesthesia, Conduction |
| D004561 | Transcutaneous Electric Nerve Stimulation |
| D000077212 | Ropivacaine |
| D000779 | Anesthetics, Local |
| D000082 | Acetaminophen |
| D000700 | Analgesics |
| D009020 | Morphine |
| D000701 | Analgesics, Opioid |
| D009294 | Narcotics |
| D005283 | Fentanyl |
| D000768 | Anesthesia, General |
| ID | Term |
|---|---|
| D000069453 | Ultrasonic Waves |
| D013016 | Sound |
| D011840 | Radiation, Nonionizing |
| D011827 | Radiation |
| D055585 | Physical Phenomena |
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
| D000698 | Analgesia |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D000777 | Anesthetics |
| D002492 | Central Nervous System Depressants |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |
| D000083 | Acetanilides |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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