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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
66
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.
A 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.
Levobupivacaine is a local anesthetic that is commonly use for anesthesia nerve blockade.
An ultrasound machine is a device that is widely used for the correct placement of the local anesthetic for anesthesia nerve blockade.
This is a specific kind of needle that is widely used for anesthesia nerve blockade.
supplemental oxygen during the block and/or during surgery
Intravenous midazolam for sedation during the block and/or during surgery
Intraoperative administration intravenous of dipyrone 30-50 mg/Kg and or intravenous ketoprofen 100 mg or diclofenac 75 mg or ketorolac 30 mg
Depending 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).
Hospital Pablo Tobón Uribe
Medellín, Antioquia, Colombia
Clínica CES
Medellín, Antioquia, Colombia
Latency period of sciatic 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.
Time frame: 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes and 30 minutes after nerve block.
Success of sciatic nerve block
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.
Time frame: 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.
Patient satisfaction
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.
Time frame: Postoperative 24 hours
Sensory block
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 leg
Time frame: 5, 10, 15, 20, 25 and 30 minutes after the block is finished
Motor block
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 leg
Time frame: 5, 10, 15, 20, 25 and 30 minutes of completion after the block is finished
First analgesic
Time of first analgesic requirement in postoperative
Time frame: 5 minutes, 30 minutes, 24 hours postoperative
Visual analog scale at rest
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
Time frame: 5 minutes, 30 minutes, 24 hours postoperative
Dynamic visual analog scale
Pain rating ranging from zero to ten with the movement
Time frame: 5 minutes, 30 minutes, 24 hours postoperative
Intraneural injection
Increased diameter nerve or visualized by ultrasound visualization of the needle into the nerve at the time of injection
Time frame: At the time of injection and execution of the block
Vascular puncture
Puncture of one or more blood vessels to visualize the needle within the vessel or to aspirate blood during block
Time frame: During the execution of the block
Paresthesia during the procedure
Paresthesia during the procedure
Time frame: At the time of the execution of the block
Systemic toxicity of local anesthetics
Systemic toxicity of local anesthetics
Time frame: During the execution of the block and 30 minutes after it
Hematoma
Hematoma
Time frame: During and inmmediately after the execution of the block
Muscle weakness
Subjective reduction in muscle strength at 24 hours postoperative
Time frame: 24 hours postoperative
Altered sensitivity
Subjective decreased sensitivity at 24 hours postoperative
Time frame: 24 hours postoperative
Cramps postoperative
Feeling cramps within 24 hours of the block
Time frame: 24 hours postoperative of the block
Punctures
Number of skin punctures during the block
Time frame: During the block
Time for the execution of nerve block
Time from placement of the transducer for the initial scan to final withdrawal of the needle
Time frame: In minutes: Time from placement of the transducer for the initial scan to final withdrawal of the needle
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