Comparison of Ultrasound and Nerve Stimulation Technique for Continuous Sciatic Nerve Block
NCT ID: NCT00497276
Last Updated: 2009-12-21
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
NA
100 participants
INTERVENTIONAL
2007-08-31
2009-10-31
Brief Summary
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Inaccurate catheter placement and spread of local anesthetic account for most failures.
The most prevalent method to place the catheter is the traditional nerve stimulation technique relying on surface anatomic landmarks and electrical stimulation to localize the sciatic nerve. In recent years ultrasound technique has been applied to provide real-time, visual guidance of catheter placement.
The purpose of this randomized, controlled trial is to compare the success rate, patient acceptance and cost-effectiveness of the ultrasound and nerve stimulation techniques.
Detailed Description
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Single-shot technique provides analgesia for two to 30 hours even using analgesics with prolonged effect (bupivacaine, levobupivacaine, ropivacaine). The duration of the block depends on the local analgesic and the anatomical location. Popliteal block with bupivacaine last up to 24 hours. Continuous, peripheral nerve block with catheter technique for two days minimizes the need for systemic analgesics and their adverse effects. Continuous, peripheral nerve block has gained popularity for foot and ankle surgery, because better analgesia is obtained compared to intravenous opioids, and similar analgesia with fewer adverse effects compared to epidural catheter technique.
Today the nerve stimulation technique is the most prevalent technique to introduce catheters for peripheral nerve blocks. The success rate for postoperative analgesia after foot and ankle surgery with popliteal catheters is variable - typically 70% in our department. The patients with catheter failure have severe postoperative pain, high opioid dosages, cognitive blurring, nausea, vomiting, reduced ambulation, increased surgical stress response and increased morbidity. Pain problems and adverse effects prolongs postoperative observation time and maybe also time to discharge.
Ultrasound technique was employed for peripheral nerve blocks for the first time in 1978. However the utility was technically limited. In recent years, the evolution of high-frequency transducers and mobile ultrasound units have facilitated the application of ultrasound-guided peripheral nerve blocks. This technique allows dynamic visualization of nerves, needle tip location and spread of local analgesic in real-time.
The empirical basis supporting the theoretical advantages of ultrasound-guided regional anesthesia consists mainly of observational studies. A few, randomized, controlled trials comparing ultrasound- and nerve stimulation technique favour the benefit of ultrasound concerning success rate, sensory onset time, duration of block, patient satisfaction and quality of block.
The purpose of this study is to establish whether ultrasound technique has higher success rate, better patient satisfaction and higher cost-effectiveness compared to electrical nerve stimulation using popliteal, sciatic catheters for postoperative analgesia after foot and ankle surgery.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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I
Ultrasound guided placement of popliteal catheter
placement of popliteal catheter
Bolus naropin 7,5 mg/ml 30 ml; infusion bupivacaine 2,5 mg/ml 5-10 ml/h
II
Nerve stimulation guided placement of popliteal catheter
placement of popliteal catheter
Bolus naropin 7,5 mg/ml 30 ml; infusion bupivacaine 2,5 mg/ml 5-10 ml/h
Interventions
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placement of popliteal catheter
Bolus naropin 7,5 mg/ml 30 ml; infusion bupivacaine 2,5 mg/ml 5-10 ml/h
Eligibility Criteria
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Inclusion Criteria
* calcaneus osteotomy
* subtalar arthrodesis
* total ankle arthroplasty
* ankle arthrodesis (non-arthroscopic) minimum age 18 years ASA I-III informed consent
Exclusion Criteria
* infection in the region of needle insertion
* systemic infection
* preoperative sciatic nerve neuropathy
* preoperative motor or sensory deficit in the operative extremity
* Charcot-Marie-Tooth disorder
* diabetic neuropathy
* severe peripheral vascular disease
* allergy to local anesthetics
* lack of understanding of the visual analogue scale
* communication problems
* dementia
* body mass index above 35
18 Years
ALL
No
Sponsors
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National Board of Health, Denmark
OTHER_GOV
University of Aarhus
OTHER
Responsible Party
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Danish Centre for Health Technology Assessment (DACEHTA)
Principal Investigators
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Thomas F Bendtsen, Ph.d.
Role: PRINCIPAL_INVESTIGATOR
Department of Anesthesiology, Aarhus University Hospital, Norrebrogade, DK-8000 Aarhus C, Denmark
Locations
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Department of Anesthesiology, Aarhus University Hospital
Aarhus, , Denmark
Countries
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References
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Ehlers L, Jensen JM, Bendtsen TF. Cost-effectiveness of ultrasound vs nerve stimulation guidance for continuous sciatic nerve block. Br J Anaesth. 2012 Nov;109(5):804-8. doi: 10.1093/bja/aes259. Epub 2012 Jul 31.
Bendtsen TF, Nielsen TD, Rohde CV, Kibak K, Linde F. Ultrasound guidance improves a continuous popliteal sciatic nerve block when compared with nerve stimulation. Reg Anesth Pain Med. 2011 Mar-Apr;36(2):181-4. doi: 10.1097/aap.0b013e31820d421f.
Other Identifiers
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0-204-03-8/27
Identifier Type: -
Identifier Source: org_study_id