Comparison of Two Techniques of Sciatic Nerve Block With Levobupivacaine 0.5% in Orthopedic Surgery
- Conditions
- Anesthesia
- Interventions
- Procedure: Sciatic nerve anesthesia blockade at bifurcation.Procedure: Sciatic nerve blockade 2 cm beyond the bifurcationDevice: Insulated Needle, (Stimuplex; Braun, Melsungen, Germany)Drug: Intravenous analgesicsProcedure: Saphenous nerve block
- Registration Number
- NCT01734954
- Lead Sponsor
- CES University
- Brief Summary
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.
- Detailed 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 66
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sciatic nerve blockade at bifurcation Sciatic nerve anesthesia blockade at bifurcation. Ultrasound-guided block at the bifurcation of the sciatic nerve Sciatic nerve blockade at bifurcation Insulated Needle, (Stimuplex; Braun, Melsungen, Germany) Ultrasound-guided block at the bifurcation of the sciatic nerve Sciatic nerve blockade at bifurcation supplemental oxygen Ultrasound-guided block at the bifurcation of the sciatic nerve Sciatic nerve blockade at bifurcation Intravenous analgesics Ultrasound-guided block at the bifurcation of the sciatic nerve Sciatic nerve blockade at bifurcation Saphenous nerve block Ultrasound-guided block at the bifurcation of the sciatic nerve Sciatic block 2 cm beyond bifurcation Sciatic nerve blockade 2 cm beyond the bifurcation Ultrasound-guided block of the sciatic nerve 2 cm beyond of the bifurcation Sciatic block 2 cm beyond bifurcation Insulated Needle, (Stimuplex; Braun, Melsungen, Germany) Ultrasound-guided block of the sciatic nerve 2 cm beyond of the bifurcation Sciatic block 2 cm beyond bifurcation supplemental oxygen Ultrasound-guided block of the sciatic nerve 2 cm beyond of the bifurcation Sciatic block 2 cm beyond bifurcation Intravenous analgesics Ultrasound-guided block of the sciatic nerve 2 cm beyond of the bifurcation Sciatic block 2 cm beyond bifurcation Saphenous nerve block Ultrasound-guided block of the sciatic nerve 2 cm beyond of the bifurcation Sciatic nerve blockade at bifurcation Midazolam Ultrasound-guided block at the bifurcation of the sciatic nerve Sciatic block 2 cm beyond bifurcation Midazolam Ultrasound-guided block of the sciatic nerve 2 cm beyond of the bifurcation
- Primary Outcome Measures
Name Time Method Latency period of sciatic nerve block. 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes and 30 minutes after nerve block. Once the nerve blockade is done, a sensory evaluation will be performed in the surgical area every five minutes to determine the onset of the sensory nerve blockade in minutes.
- Secondary Outcome Measures
Name Time Method Success of sciatic nerve block Every 5 minutes until 30 minutes until the end of the procedure for the nerve block; an additional measure will be performed at the end of of the surgery. The time to achieve a complete sensory nerve block, reached maximum at 30 minutes, in full distribution of tibial nerve and common fibular nerve for anesthesia.
Patient satisfaction Postoperative 24 hours Using a categorical score we will measure satisfaction of nerve-block-procedure satisfaction and analgesia quality one day after surgery: patients will choose one of three options: no satisfied, satisfied or very satisfied.
Sensory block 5, 10, 15, 20, 25 and 30 minutes after the block is finished Evaluation in 5, 10, 15, 20, 25 and 30 minutes after the procedure in the distribution of the common peroneal and tibial nerves
0: Complete sensory block
1. Almost complete sensory block: Decreased sensation to pinprick with a 24 gauge hypodermic needle
2. Feeling normal (for each component: tibial and common peroneal) compared with the contralateral legMotor block 5, 10, 15, 20, 25 and 30 minutes of completion after the block is finished Evaluation in 5, 10, 15, 20, 25 and 30 minutes after the procedure in the distribution of the common peroneal and tibial nerves 0: Complete motor blockade
1. Motor block almost complete
2. No motor block (for the tibial component for plantarflexion and dorsiflexion with the common peroneal) compared with the contralateral legFirst analgesic 5 minutes, 30 minutes, 24 hours postoperative Time of first analgesic requirement in postoperative
Visual analog scale at rest 5 minutes, 30 minutes, 24 hours postoperative Pain rating ranging from zero to ten VAS 0: no pain VAS 1-3: Mild pain VAS 4-6: Moderate Pain VAS 7-10: Severe pain
Dynamic visual analog scale 5 minutes, 30 minutes, 24 hours postoperative Pain rating ranging from zero to ten with the movement
Intraneural injection At the time of injection and execution of the block Increased diameter nerve or visualized by ultrasound visualization of the needle into the nerve at the time of injection
Vascular puncture During the execution of the block Puncture of one or more blood vessels to visualize the needle within the vessel or to aspirate blood during block
Paresthesia during the procedure At the time of the execution of the block Paresthesia during the procedure
Systemic toxicity of local anesthetics During the execution of the block and 30 minutes after it Systemic toxicity of local anesthetics
Hematoma During and inmmediately after the execution of the block Hematoma
Muscle weakness 24 hours postoperative Subjective reduction in muscle strength at 24 hours postoperative
Altered sensitivity 24 hours postoperative Subjective decreased sensitivity at 24 hours postoperative
Cramps postoperative 24 hours postoperative of the block Feeling cramps within 24 hours of the block
Punctures During the block Number of skin punctures during the block
Time for the execution of nerve block In minutes: Time from placement of the transducer for the initial scan to final withdrawal of the needle Time from placement of the transducer for the initial scan to final withdrawal of the needle
Trial Locations
- Locations (2)
Hospital Pablo Tobón Uribe
🇨🇴Medellín, Antioquia, Colombia
Clínica CES
🇨🇴Medellín, Antioquia, Colombia