NCT01999647

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

Intraneural Injection of Ropivacaine for Subgluteal Sciatic Nerve Block Leads to Faster Onset and Higher Success Rates: a Randomized, Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (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), 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.

Conditions

• Orthopedic Disorders
• Foot Diseases
• Injuries, Leg
• Injuries, Foot
• Injuries, Knee

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	Ropivacaine	Thirty milliliters of 0.75% (wt/vol) ropivacaine will be used for the sciatic nerve block.

Timeline

• Start date: 2011-12-01
• Primary completion: 2012-09-01
• Completion: 2012-12-01
• First posted: 2013-12-03
• Last updated: 2013-12-04

Locations

1 site across 1 country: Italy