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

NCT01981291 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2013-11-19

No results posted yet for this study

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.

Conditions

  • Orthopedic Surgical Procedures
  • Postoperative Pain

Interventions

PROCEDURE

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.

PROCEDURE

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.

PROCEDURE

Femoral Nerve Block

Patients will receive an ultrasound-guided femoral nerve block using a short- or long-acting local anesthetic, as deemed indicated.

PROCEDURE

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.

DRUG

Mepivacaine

Thirty milliliters of 1.5% (wt/vol) mepivacaine will be used for the sciatic nerve block.

Sponsors & Collaborators

  • University of Parma

    lead OTHER

Principal Investigators

  • Marco Baciarello, MD · University of Parma

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2013-07-31
Completion
2013-10-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01981291 on ClinicalTrials.gov