Duration of Sciatic Nerve Block After Injection of Local Anesthetic In or Around the Nerve
NCT ID: NCT01981291
Last Updated: 2013-11-19
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
PHASE4
120 participants
INTERVENTIONAL
2012-10-31
2013-10-31
Brief Summary
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Some reports of accidental intraneural injection mention an extremely long duration. When different drugs and doses were evaluated in a clinical trial of intraneural injection, a longer-than-expected duration was reported.
The investigators will compare the two types of injection using the same drug, so as to determine if there is an actual difference in duration.
Detailed Description
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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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Perineural
Patients in this group will receive a perineural injection of mepivacaine for subgluteal sciatic nerve block, in addition to a femoral nerve block and patient-controlled postoperative analgesia.
Perineural Injection for Subgluteal Sciatic Nerve Block
The injection will start as the needle indents the outermost discernible layer of the nerve (epineurium) under ultrasound guidance. The injection will be adjudicated as "intraneural" if the drug infiltrates the space between the epimysium of the surrounding muscles and the outer epineurium of the sciatic nerve.
Short-axis real-time ultrasound imaging will be used, with an in-plane needle approach.
Femoral Nerve Block
Patients will receive an ultrasound-guided femoral nerve block using a short- or long-acting local anesthetic, as deemed indicated.
Patient-controlled postoperative analgesia
Patients will receive a patient-controlled intravenous or perineural catheter-based analgesia, depending on their preference and the anesthesiologist's indication.
Mepivacaine
Thirty milliliters of 1.5% (wt/vol) mepivacaine will be used for the sciatic nerve block.
Intraneural
Patients in this group will receive an intraneural injection of mepivacaine for subgluteal sciatic nerve block, in addition to a femoral nerve block and patient-controlled postoperative analgesia.
Intraneural Injection for Subgluteal Sciatic Nerve Block
The injection will start as the needle penetrates the outermost discernible layer of the nerve (epineurium) under ultrasound guidance. The injection will be adjudicated as "intraneural" if nerve cross section expansion and a reduction in echogenicity are observed.
Short-axis real-time ultrasound imaging will be used, with an in-plane needle approach.
Femoral Nerve Block
Patients will receive an ultrasound-guided femoral nerve block using a short- or long-acting local anesthetic, as deemed indicated.
Patient-controlled postoperative analgesia
Patients will receive a patient-controlled intravenous or perineural catheter-based analgesia, depending on their preference and the anesthesiologist's indication.
Mepivacaine
Thirty milliliters of 1.5% (wt/vol) mepivacaine will be used for the sciatic nerve block.
Interventions
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Intraneural Injection for Subgluteal Sciatic Nerve Block
The injection will start as the needle penetrates the outermost discernible layer of the nerve (epineurium) under ultrasound guidance. The injection will be adjudicated as "intraneural" if nerve cross section expansion and a reduction in echogenicity are observed.
Short-axis real-time ultrasound imaging will be used, with an in-plane needle approach.
Perineural Injection for Subgluteal Sciatic Nerve Block
The injection will start as the needle indents the outermost discernible layer of the nerve (epineurium) under ultrasound guidance. The injection will be adjudicated as "intraneural" if the drug infiltrates the space between the epimysium of the surrounding muscles and the outer epineurium of the sciatic nerve.
Short-axis real-time ultrasound imaging will be used, with an in-plane needle approach.
Femoral Nerve Block
Patients will receive an ultrasound-guided femoral nerve block using a short- or long-acting local anesthetic, as deemed indicated.
Patient-controlled postoperative analgesia
Patients will receive a patient-controlled intravenous or perineural catheter-based analgesia, depending on their preference and the anesthesiologist's indication.
Mepivacaine
Thirty milliliters of 1.5% (wt/vol) mepivacaine will be used for the sciatic nerve block.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* ASA Physical Status Class I-III
* Consenting to surgery under peripheral nerve block anesthesia (sciatic + femoral/saphenous block)
Exclusion Criteria
* Exhibiting signs of neuropathy in the ipsilateral extremity
* Inability to satisfactorily image the sciatic nerve in the opinion of the attending anesthesiologist
18 Years
ALL
No
Sponsors
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University of Parma
OTHER
Responsible Party
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Marco Baciarello
Assistant Professor, Anesthesia, Critical Care and Pain Medicine
Principal Investigators
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Marco Baciarello, MD
Role: PRINCIPAL_INVESTIGATOR
University of Parma
Locations
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Anesthesia, Critical Care and Pain Medicine - University of Parma
Parma, PR, Italy
Countries
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References
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Benhamou D, Blonski E, Levy P, Plessis E, Chalhoub V. Ultra-long duration of a peripheral nerve block: a possible consequence of intraneural (subepineural) local anaesthetic injection. Ann Fr Anesth Reanim. 2010 Jul-Aug;29(7-8):589-91. doi: 10.1016/j.annfar.2010.05.032. Epub 2010 Jul 13.
Nader A, Kendall MC, De Oliveira GS Jr, Puri L, Tureanu L, Brodskaia A, Asher Y, Parimi V, McCarthy RJ. A dose-ranging study of 0.5% bupivacaine or ropivacaine on the success and duration of the ultrasound-guided, nerve-stimulator-assisted sciatic nerve block: a double-blind, randomized clinical trial. Reg Anesth Pain Med. 2013 Nov-Dec;38(6):492-502. doi: 10.1097/AAP.0b013e3182a4bddf.
Other Identifiers
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ANEST-ORT-03
Identifier Type: -
Identifier Source: org_study_id