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

University of Parma

Status: Completed

Conditions: Injuries, Knee; Foot Diseases; Injuries, Leg; Orthopedic Disorders; Injuries, Foot

Treatments: Procedure: Perineural Injection for Subgluteal Sciatic Nerve Block; Drug: Ropivacaine; Procedure: Femoral Nerve Block; Procedure: Patient-Controlled Postoperative Analgesia; Procedure: Intraneural Injection for Subgluteal Sciatic Nerve Block

Study type: Interventional

Funder types: Other

Identifiers

NCT01999647

ANEST-ORT-04

Details and patient eligibility

About

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.

Full 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.

Enrollment: 64 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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 any neurological disturbance of the ipsilateral lower extremity
• Inability to satisfactorily image the sciatic nerve in the opinion of the attending anesthesiologist

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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64 participants in 2 patient groups

Perineural

Active Comparator group

Description:

Patients in this group will receive a perineural injection for subgluteal sciatic nerve block under real-time, short-axis, in-plane ultrasound guidance, in addition to a femoral nerve block and patient-controlled postoperative analgesia. Ropivacaine will be used for the sciatic nerve block, whereas the choice of agent for the femoral nerve block is left to the attending anesthesiologist.

Treatment:

Procedure: Patient-Controlled Postoperative Analgesia

Drug: Ropivacaine

Procedure: Perineural Injection for Subgluteal Sciatic Nerve Block

Procedure: Femoral Nerve Block

Intraneural

Experimental group

Description:

Patients in this group will receive an intraneural injection for subgluteal sciatic nerve block under real-time, short-axis, in-plane ultrasound guidance, in addition to a femoral nerve block and patient-controlled postoperative analgesia. Ropivacaine will be used for the sciatic nerve block, whereas the choice of agent for the femoral nerve block is left to the attending anesthesiologist.

Treatment:

Procedure: Patient-Controlled Postoperative Analgesia

Procedure: Intraneural Injection for Subgluteal Sciatic Nerve Block

Drug: Ropivacaine

Procedure: Femoral Nerve Block