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Efficacy of Ultrasound-Guided Local Anesthetic Injection Into or Around the Sciatic Nerve for Lower Limb Anesthesia

Primary Purpose

Orthopedic Disorders, Foot Diseases, Injuries, Leg

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Intraneural Injection for Subgluteal Sciatic Nerve Block
Perineural Injection for Subgluteal Sciatic Nerve Block
Femoral Nerve Block
Patient-Controlled Postoperative Analgesia
Ropivacaine
Sponsored by
University of Parma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Orthopedic Disorders focused on measuring Lower Extremity, Sciatic Nerve, Anesthetics, Local, Ropivacaine, Ultrasonography

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Undergoing non-emergent orthopedic procedure of knee, leg, foot with thigh tourniquet
  • ASA Physical Status Class I-III
  • Consenting to surgery under peripheral nerve block anesthesia (sciatic + femoral/saphenous block)

Exclusion Criteria:

  • Unable to understand or communicate for the purpose of the study
  • Exhibiting any neurological disturbance of the ipsilateral lower extremity
  • Inability to satisfactorily image the sciatic nerve in the opinion of the attending anesthesiologist

Sites / Locations

  • Anesthesia, Critical Care and Pain Medicine - University of Parma

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Perineural

Intraneural

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Onset Time of Sciatic Nerve Block
Time to onset of sciatic nerve anesthesia, defined as both following criteria: Sensory: does not feel pain or discomfort when pricked with a 25G needle. Motor: able to slightly curl toes; unable to flex the ankle.

Secondary Outcome Measures

Success Rate of Sciatic Nerve Blocks
The percentage of patients who attain the criteria for block success within 30 minutes of the injection. Investigators will also report the percentage of patients who successfully complete surgery without significant additional analgesia (see below); this will be defined as "clinical success rate."
Incidence and Prevalence of Neurologic Disturbances
Patients will be interviewed at ~4 h (block resolution visit), 7 days and (if necessary) at 30 days to assess for residual neurologic disturbances in the sciatic nerve territory. The incidence/prevalence of these phenomena will be noted.
Differences in Time to Resolution of Sciatic Nerve Block
The time at which sensory and motor function of the sciatic nerve have recovered at least to the following criteria: Sensory: patients feel discomfort when pricked with a thin needle (25G) Motor: patients may move both toes and ankle, albeit with reduced strength This outcome measure will be examined by an investigator every 30-60 min and reported by patients as "time to return of sensation and movement". The investigator-reported value will be preferred if both are available.

Full Information

First Posted
November 25, 2013
Last Updated
December 2, 2013
Sponsor
University of Parma
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1. Study Identification

Unique Protocol Identification Number
NCT01999647
Brief Title
Efficacy of Ultrasound-Guided Local Anesthetic Injection Into or Around the Sciatic Nerve for Lower Limb Anesthesia
Official Title
Intraneural Injection of Ropivacaine for Subgluteal Sciatic Nerve Block Leads to Faster Onset and Higher Success Rates: a Randomized, Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Parma

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study was designed to assess whether the injection of local anesthetic into the nerve (intraneural), as opposed to around it (perineural), requires a shorter time to develop surgical anesthesia of the lower leg. 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
This will be a randomized, controlled, patient- and observer-blinded trial assessing block characteristics after intra- or perineural injection of ropivacaine for subgluteal sciatic nerve blocks performed for elective surgery of the lower limb.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Orthopedic Disorders, Foot Diseases, Injuries, Leg, Injuries, Foot, Injuries, Knee
Keywords
Lower Extremity, Sciatic Nerve, Anesthetics, Local, Ropivacaine, Ultrasonography

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Perineural
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Intraneural
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Intraneural Injection for Subgluteal Sciatic Nerve Block
Other Intervention Name(s)
Injection beneath the common investing extraneural layer, Subepineural Injection, Gluteal sciatic nerve block, Subparaneural injection
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Perineural Injection for Subgluteal Sciatic Nerve Block
Other Intervention Name(s)
Injection outside the common investing extraneural layer, Epineural injection, Extraneural injection, Injection outside the paraneurium
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Femoral Nerve Block
Intervention Description
Patients will receive an ultrasound-guided femoral nerve block using a short- or long-acting local anesthetic, as deemed indicated.
Intervention Type
Procedure
Intervention Name(s)
Patient-Controlled Postoperative Analgesia
Other Intervention Name(s)
PCA, PCIVA, PCCPNB, Patient-controlled continuous peripheral nerve block
Intervention Description
Patients will receive a patient-controlled intravenous or perineural catheter-based analgesia, depending on their preference and the anesthesiologist's indication.
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Other Intervention Name(s)
Local Anesthetic, Naropin, Naropine
Intervention Description
Thirty milliliters of 0.75% (wt/vol) ropivacaine will be used for the sciatic nerve block.
Primary Outcome Measure Information:
Title
Onset Time of Sciatic Nerve Block
Description
Time to onset of sciatic nerve anesthesia, defined as both following criteria: Sensory: does not feel pain or discomfort when pricked with a 25G needle. Motor: able to slightly curl toes; unable to flex the ankle.
Time Frame
≤30 minutes after block performance
Secondary Outcome Measure Information:
Title
Success Rate of Sciatic Nerve Blocks
Description
The percentage of patients who attain the criteria for block success within 30 minutes of the injection. Investigators will also report the percentage of patients who successfully complete surgery without significant additional analgesia (see below); this will be defined as "clinical success rate."
Time Frame
≤30 min after block performance
Title
Incidence and Prevalence of Neurologic Disturbances
Description
Patients will be interviewed at ~4 h (block resolution visit), 7 days and (if necessary) at 30 days to assess for residual neurologic disturbances in the sciatic nerve territory. The incidence/prevalence of these phenomena will be noted.
Time Frame
30 days after anesthesia performance
Title
Differences in Time to Resolution of Sciatic Nerve Block
Description
The time at which sensory and motor function of the sciatic nerve have recovered at least to the following criteria: Sensory: patients feel discomfort when pricked with a thin needle (25G) Motor: patients may move both toes and ankle, albeit with reduced strength This outcome measure will be examined by an investigator every 30-60 min and reported by patients as "time to return of sensation and movement". The investigator-reported value will be preferred if both are available.
Time Frame
<12 h
Other Pre-specified Outcome Measures:
Title
Extra- vs. Intraneural Minimum Electrical Stimulation Thresholds
Description
The minimum electrical nerve stimulation threshold will be recorded as a function of needle tip position.
Time Frame
During performance of nerve block (<30 min)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Undergoing non-emergent orthopedic procedure of knee, leg, foot with thigh tourniquet ASA Physical Status Class I-III Consenting to surgery under peripheral nerve block anesthesia (sciatic + femoral/saphenous block) Exclusion Criteria: Unable to understand or communicate for the purpose of the study Exhibiting any neurological disturbance of the ipsilateral lower extremity Inability to satisfactorily image the sciatic nerve in the opinion of the attending anesthesiologist
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marco Baciarello, MD
Organizational Affiliation
University of Parma
Official's Role
Principal Investigator
Facility Information:
Facility Name
Anesthesia, Critical Care and Pain Medicine - University of Parma
City
Parma
State/Province
PR
ZIP/Postal Code
43126
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
22005661
Citation
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.
Results Reference
background
PubMed Identifier
22609646
Citation
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.
Results Reference
background
PubMed Identifier
19608846
Citation
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.
Results Reference
background

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Efficacy of Ultrasound-Guided Local Anesthetic Injection Into or Around the Sciatic Nerve for Lower Limb Anesthesia

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