NCT01981291

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

Duration of Subgluteal Sciatic Nerve Block After Intra- or Perineural Injection of Mepivacaine: a Randomized, Controlled Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: University of Parma · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Orthopedic Surgical Procedures
• Postoperative Pain

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2012-10-01
• Primary completion: 2013-07-01
• Completion: 2013-10-01
• First posted: 2013-11-11
• Last updated: 2013-11-19

Locations

1 site across 1 country: Italy