Efficacy of Ultrasound-Guided Local Anesthetic Injection Into or Around the Sciatic Nerve for Lower Limb Anesthesia
NCT ID: NCT01999647
Last Updated: 2013-12-04
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
64 participants
INTERVENTIONAL
2011-12-31
2012-12-31
Brief Summary
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The investigators will compare the two types of injection using the same drug, so as to determine if there is an actual difference onset time. They will also examine the overall success rate of either kind of sciatic nerve blocks as the sole anesthetic for non-emergent orthopedic surgery.
The safety of these procedures will be examined by in-hospital and phone-call follow-up contacts.
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 for subgluteal sciatic nerve block under real-time, short-axis, in-plane ultrasound guidance, in addition to a femoral nerve block and patient-controlled postoperative analgesia. Ropivacaine will be used for the sciatic nerve block, whereas the choice of agent for the femoral nerve block is left to the attending anesthesiologist.
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.
Ropivacaine
Thirty milliliters of 0.75% (wt/vol) ropivacaine will be used for the sciatic nerve block.
Intraneural
Patients in this group will receive an intraneural injection for subgluteal sciatic nerve block under real-time, short-axis, in-plane ultrasound guidance, in addition to a femoral nerve block and patient-controlled postoperative analgesia. Ropivacaine will be used for the sciatic nerve block, whereas the choice of agent for the femoral nerve block is left to the attending anesthesiologist.
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.
Ropivacaine
Thirty milliliters of 0.75% (wt/vol) ropivacaine 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.
Ropivacaine
Thirty milliliters of 0.75% (wt/vol) ropivacaine 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 any neurological disturbance of the ipsilateral lower 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 of Anesthesiology, 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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Tran DQ, Dugani S, Pham K, Al-Shaafi A, Finlayson RJ. A randomized comparison between subepineural and conventional ultrasound-guided popliteal sciatic nerve block. Reg Anesth Pain Med. 2011 Nov-Dec;36(6):548-52. doi: 10.1097/AAP.0b013e318235f566.
Andersen HL, Andersen SL, Tranum-Jensen J. Injection inside the paraneural sheath of the sciatic nerve: direct comparison among ultrasound imaging, macroscopic anatomy, and histologic analysis. Reg Anesth Pain Med. 2012 Jul-Aug;37(4):410-4. doi: 10.1097/AAP.0b013e31825145f3.
Robards C, Hadzic A, Somasundaram L, Iwata T, Gadsden J, Xu D, Sala-Blanch X. Intraneural injection with low-current stimulation during popliteal sciatic nerve block. Anesth Analg. 2009 Aug;109(2):673-7. doi: 10.1213/ane.0b013e3181aa2d73.
Other Identifiers
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ANEST-ORT-04
Identifier Type: -
Identifier Source: org_study_id