Anesthesia | Comparison of Two Techniques of Sciatic Nerve Block With Levobupivacaine 0.5% in Orthopedic Surgery
Anesthesia research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Procedure:Sciatic nerve anesthesia blockade at bifurcation.A proximal and distal initial scan and define the site to block the bifurcation. A puncture with an insulated needle guided by ultrasound and injection of levobupivacaine circumferential in 0.5% and a total volume of 20 mL.
Procedure:Sciatic nerve blockade 2 cm beyond the bifurcationA proximal and distal initial scan and define the sites to block: tibial and peroneal nerves separate distal 2 cm from the bifurcation site. A puncture with an insulated needle guided by ultrasound and injection of levobupivacaine circumferential in 0.5% 10 mL tibial nerve and 10 mL to the peroneal nerve.
Drug:Levobupivacaine 0.5%: 20 mlLevobupivacaine is a local anesthetic that is commonly use for anesthesia nerve blockade.
Device:Portable Ultrasound Machine: Sonosite, M-Turbo, Bothell, WAAn ultrasound machine is a device that is widely used for the correct placement of the local anesthetic for anesthesia nerve blockade.
Device:Insulated Needle, (Stimuplex; Braun, Melsungen, Germany)This is a specific kind of needle that is widely used for anesthesia nerve blockade.
Drug:supplemental oxygensupplemental oxygen during the block and/or during surgery
Drug:MidazolamIntravenous midazolam for sedation during the block and/or during surgery
Drug:Intravenous analgesicsIntraoperative administration intravenous of dipyrone 30-50 mg/Kg and or intravenous ketoprofen 100 mg or diclofenac 75 mg or ketorolac 30 mg
Procedure:Saphenous nerve blockDepending on sensitive territory committed by the type of surgery suprapatellar saphenous nerve block guided by ultrasound with 100 mm Stimuplex needle and injection of levobupivacaine 0.5% (total volume: 5 ml).
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Sciatic nerve blockade at bifurcationUltrasound-guided block at the bifurcation of the sciatic nerve
Sciatic block 2 cm beyond bifurcationUltrasound-guided block of the sciatic nerve 2 cm beyond of the bifurcation
Start Date: April 2013
Completed Date: September 2013
Primary Outcome: Latency period of sciatic nerve block.
Secondary Outcome: Success of sciatic nerve block
Study sponsors, principal investigator, and references
Principal Investigator: Marta I Berrio, MD
Lead Sponsor: CES University
Collaborator: Hospital Pablo Tobón Uribe