Nerve Block Clinical Trial
Official title:
Ultrasound Guidance or Electrical Nerve Stimulation for Interscalene Brachial Plexus Block: a Randomized, Controlled Trial
Verified date | November 2009 |
Source | University of Parma |
Contact | n/a |
Is FDA regulated | No |
Health authority | Italy: Ethics Committee |
Study type | Interventional |
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.
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Italy | University Hospital / Azienda Ospedaliero-Universitaria | Parma | PR |
Lead Sponsor | Collaborator |
---|---|
University of Parma |
Italy,
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
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 |
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