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Duration of Sciatic Nerve Block After Injection of Local Anesthetic In or Around the Nerve

Primary Purpose

Orthopedic Surgical Procedures, Postoperative Pain

Status
Completed
Phase
Phase 4
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
Mepivacaine
Sponsored by
University of Parma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Orthopedic Surgical Procedures focused on measuring Lower Extremity, Sciatic Nerve, Anesthesia, Regional, Anesthetics, Local, Mepivacaine, 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 signs of neuropathy in the ipsilateral 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 of mepivacaine for subgluteal sciatic nerve block, in addition to a femoral nerve block and patient-controlled postoperative analgesia.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Block Onset Time
Time to onset of sciatic nerve anesthesia, defined as meeting at least the 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.
Success Rate of Anesthetic Nerve Blocks
The percentage of patients who attain the criteria for block success within 30 minutes of the injeciton. 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.

Full Information

First Posted
November 4, 2013
Last Updated
November 18, 2013
Sponsor
University of Parma
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1. Study Identification

Unique Protocol Identification Number
NCT01981291
Brief Title
Duration of Sciatic Nerve Block After Injection of Local Anesthetic In or Around the Nerve
Official Title
Duration of Subgluteal Sciatic Nerve Block After Intra- or Perineural Injection of Mepivacaine: a Randomized, Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
October 2013 (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), leads to longer anesthesia and analgesia of the leg. 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
This randomized, controlled trial will investigate prospectively for differences in sensory and motor block duration after intra- or perineural injection of 1.5% (wt/vol) mepivacaine, a short-acting local anesthetic.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Orthopedic Surgical Procedures, Postoperative Pain
Keywords
Lower Extremity, Sciatic Nerve, Anesthesia, Regional, Anesthetics, Local, Mepivacaine, Ultrasonography

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Perineural
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Intraneural
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Intraneural Injection for Subgluteal Sciatic Nerve Block
Other Intervention Name(s)
Injection beneath the common investing external 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 external layer, Epineural injection, Extraneural injection
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)
Mepivacaine
Other Intervention Name(s)
Local Anesthetic, Carbocaine
Intervention Description
Thirty milliliters of 1.5% (wt/vol) mepivacaine will be used for the sciatic nerve block.
Primary Outcome Measure Information:
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
Secondary Outcome Measure Information:
Title
Block Onset Time
Description
Time to onset of sciatic nerve anesthesia, defined as meeting at least the 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 min
Title
Success Rate of Anesthetic Nerve Blocks
Description
The percentage of patients who attain the criteria for block success within 30 minutes of the injeciton. 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
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
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 the procedure)

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 signs of neuropathy in the ipsilateral 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
20630694
Citation
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.
Results Reference
background
PubMed Identifier
24108248
Citation
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.
Results Reference
background

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Duration of Sciatic Nerve Block After Injection of Local Anesthetic In or Around the Nerve

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