Saphenous Nerve Block: Single Shot Versus Continuous Infusion to Supplement a Continuous Sciatic Nerve Block After Major Ankle Surgery
NCT ID: NCT01445210
Last Updated: 2012-10-19
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
50 participants
INTERVENTIONAL
2011-09-30
2012-10-31
Brief Summary
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Sensation from the ankle are carried by three nerves: The tibial and peroneal nerve (unified in the sciatic nerve) and the saphenous nerve.
Study purpose is to test whether continuous infusion of local analgesics by saphenous nerve catheter provide a better treatment of pain in comparison with a single injection nerve block. In addition cost-effectiveness of the two methods are compared.
The 50 patients of the trial are randomized in clusters of ten. We intend to do a preliminary analysis of the data from the first 40 patients. However, it is not an interim analysis. Fifty patients will be included independent of the result of the preliminary analysis. The random allocation of the last 10 patients will also be double-blinded.
Detailed Description
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Continuous, peripheral nerve block with catheter technique for two days minimizes the need for systemic analgesics. Today such a continuous sciatic nerve block is part of the standard pain treatment after major ankle surgery on Aarhus University Hospital. Despite accurate placement of the catheter many patients are in great pain because the saphenous nerve remain unaffected. A single injection block relieve the pain but a block with Ropivacaine only last 8-15 hours.
Severe postoperative pain leads to 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.
The aim of the study establish whether continuous saphenous nerve block is efficient (pain relief or reduced opioid consumption) and justified (cost-effectiveness analysis) compared with single injection block.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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0,2% Ropivacaine
Patients randomized to the experimental group receive a continuous infusion of 0,2 % Ropivacaine by elastomeric infusion pump at 5 ml/h in the saphenous catheter after major ankle surgery. Infusion for 48 postoperative hours.
All patients receive a preoperative single shot of Ropivacaine around saphenous and sciatic nerve and a postoperative continuous sciatic nerve block.
Continuous saphenous nerve block
0,2% Ropivacaine by elastomeric infusion pump at 5 ml/h for 48 postoperative hours
Control
Patients randomized to the control group receive a continuous infusion of isoton saline by elastomeric infusion pump at 5 ml/h in their catheter after major ankle surgery. Infusion for 48 postoperative hours.
All patients receive a preoperative single shot of Ropivacaine around saphenous and sciatic nerve and a postoperative continuous sciatic nerve block.
Placebo
Isoton saline by elastomeric infusion pump at 5 ml/h for 48 postoperative hours
Interventions
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Continuous saphenous nerve block
0,2% Ropivacaine by elastomeric infusion pump at 5 ml/h for 48 postoperative hours
Placebo
Isoton saline by elastomeric infusion pump at 5 ml/h for 48 postoperative hours
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* subtalar fusion
* ankle fusion (non arthroscopic)
Exclusion Criteria
* infection in the region of needle insertion
* systemic infection
* preoperative consumption of high dose opioid
* preoperative sciatic or femoral nerve neuropathy
* preoperative sensory deficit in either of the lower extremities
* Charcot-Marie-Tooth disorder
* diabetic neuropathy
* severe peripheral vascular disease
* allergy to local anesthetics
* lack of understanding of Numeric Rank Scale (NRS)
* communication problems
* dementia
* body mass index above 35
* bilateral continuous sciatic nerve block
* lack of consent
18 Years
ALL
No
Sponsors
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Aarhus University Hospital
OTHER
University of Aarhus
OTHER
Responsible Party
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Principal Investigators
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Thomas F Bendtsen, ph.d., MD
Role: PRINCIPAL_INVESTIGATOR
Aarhus University Hospital
Locations
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Aarhus University Hospital
Aarhus, , Denmark
Countries
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References
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Fisker AK, Iversen BN, Christensen S, Linde F, Nielsen KK, Borglum J, Bendtsen TF. Combined saphenous and sciatic catheters for analgesia after major ankle surgery: a double-blinded randomized controlled trial. Can J Anaesth. 2015 Aug;62(8):875-82. doi: 10.1007/s12630-015-0379-y. Epub 2015 Apr 8.
Other Identifiers
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2011-0184
Identifier Type: -
Identifier Source: org_study_id