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
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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