Comparison of Two Techniques of Sciatic Nerve Block With Levobupivacaine 0.5% in Orthopedic Surgery

CES University

Status: Unknown

Conditions: Anesthesia

Treatments: Drug: Midazolam; Procedure: Sciatic nerve anesthesia blockade at bifurcation.; Drug: Intravenous analgesics; Drug: supplemental oxygen; Device: Insulated Needle, (Stimuplex; Braun, Melsungen, Germany); Procedure: Sciatic nerve blockade 2 cm beyond the bifurcation; Procedure: Saphenous nerve block; Device: Portable Ultrasound Machine: Sonosite, M-Turbo, Bothell, WA; Drug: Levobupivacaine 0.5%: 20 ml

Study type: Interventional

Funder types: Other

Identifiers

NCT01734954

IACES

Details and patient eligibility

About

The purpose of this study is to evaluate the latency period (timing between the injection of the local anesthetic and the onset of complete sensory nerve block) of two approaches for ultrasound-guided popliteal sciatic nerve block: One of the approaches is the injection of the anesthetic just at the site of the bifurcation of the sciatic nerve and the other one is injecting the local anesthetic at least 2 cm beyond the bifurcation of the aforementioned nerve. Our main hypothesis is that the first approach will decrease the latency period, and probably, will increase the success rate of the nerve block as well as patient satisfaction.

Full description

Compare the effectiveness of nerve blockade at the bifurcation site of the sciatic nerve versus distal (tibial and peroneal) using only levobupivacaine 0.5%. The primary outcome is the latency period of the nerve blockade; the secondary outcomes are rate of success of the procedure as well as patient satisfaction.

Enrollment: 66 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients scheduled for ankle or foot surgery at Hospital Pablo Tobón Uribe and Clínica CES.
• Physical status classification of the American Society of Anesthesiologists (ASA) 1-3.
• Age: 18-70 years.
• Weight: 40-100 kg
• Taller than 140 cm.

Exclusion criteria

• No patient acceptance.
• Contraindications for nerve block (coagulopathy, local anesthetics allergy, sepsis, infection at the site of puncture).
• Neuropathy or myopathy affecting the lower limb.
• Psychiatric or neurological diseases that alter the evaluation of patient.
• Arrhythmias.
• Heart failure.
• Diabetes Mellitus.
• Pregnancy.
• Language barriers.
• Anticoagulation.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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66 participants in 2 patient groups

Sciatic nerve blockade at bifurcation

Experimental group

Description:

Ultrasound-guided block at the bifurcation of the sciatic nerve

Treatment:

Drug: Levobupivacaine 0.5%: 20 ml

Procedure: Saphenous nerve block

Drug: Intravenous analgesics

Device: Portable Ultrasound Machine: Sonosite, M-Turbo, Bothell, WA

Drug: Midazolam

Device: Insulated Needle, (Stimuplex; Braun, Melsungen, Germany)

Drug: supplemental oxygen

Procedure: Sciatic nerve anesthesia blockade at bifurcation.

Sciatic block 2 cm beyond bifurcation

Experimental group

Description:

Ultrasound-guided block of the sciatic nerve 2 cm beyond of the bifurcation

Treatment:

Drug: Levobupivacaine 0.5%: 20 ml

Procedure: Saphenous nerve block

Drug: Intravenous analgesics

Device: Portable Ultrasound Machine: Sonosite, M-Turbo, Bothell, WA

Drug: Midazolam

Procedure: Sciatic nerve blockade 2 cm beyond the bifurcation

Device: Insulated Needle, (Stimuplex; Braun, Melsungen, Germany)

Drug: supplemental oxygen