Comparison of Two Techniques of Sciatic Nerve Block With Levobupivacaine 0.5% in Orthopedic Surgery
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Sciatic nerve blockade at bifurcation Ultrasound-guided block at the bifurcation of the sciatic nerve |
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.
Other Names:
Drug: Levobupivacaine 0.5%: 20 ml
Levobupivacaine is a local anesthetic that is commonly use for anesthesia nerve blockade.
Other Names:
Device: Portable Ultrasound Machine: Sonosite, M-Turbo, Bothell, WA
An ultrasound machine is a device that is widely used for the correct placement of the local anesthetic for anesthesia nerve blockade.
Other Names:
Device: Insulated Needle, (Stimuplex; Braun, Melsungen, Germany)
This is a specific kind of needle that is widely used for anesthesia nerve blockade.
Other Names:
Drug: supplemental oxygen
supplemental oxygen during the block and/or during surgery
Other Names:
Drug: Midazolam
Intravenous midazolam for sedation during the block and/or during surgery
Drug: Intravenous analgesics
Intraoperative 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 block
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).
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| Experimental: Sciatic block 2 cm beyond bifurcation Ultrasound-guided block of the sciatic nerve 2 cm beyond of the bifurcation |
Procedure: Sciatic nerve blockade 2 cm beyond the bifurcation
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.
Other Names:
Drug: Levobupivacaine 0.5%: 20 ml
Levobupivacaine is a local anesthetic that is commonly use for anesthesia nerve blockade.
Other Names:
Device: Portable Ultrasound Machine: Sonosite, M-Turbo, Bothell, WA
An ultrasound machine is a device that is widely used for the correct placement of the local anesthetic for anesthesia nerve blockade.
Other Names:
Device: Insulated Needle, (Stimuplex; Braun, Melsungen, Germany)
This is a specific kind of needle that is widely used for anesthesia nerve blockade.
Other Names:
Drug: supplemental oxygen
supplemental oxygen during the block and/or during surgery
Other Names:
Drug: Midazolam
Intravenous midazolam for sedation during the block and/or during surgery
Drug: Intravenous analgesics
Intraoperative 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 block
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).
|
Outcome Measures
Primary Outcome Measures
- 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
- 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 Almost complete sensory block: Decreased sensation to pinprick with a 24 gauge hypodermic needle Feeling normal (for each component: tibial and common peroneal) compared with the contralateral leg
- Motor 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 Motor block almost complete No motor block (for the tibial component for plantarflexion and dorsiflexion with the common peroneal) compared with the contralateral leg
- First 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients scheduled for ankle or foot surgery at Hospital Pablo Tobón Uribe and Clínica CES.
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Physical status classification of the American Society of Anesthesiologists (ASA) 1-3.
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Age: 18-70 years.
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Weight: 40-100 kg
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Taller than 140 cm.
Exclusion Criteria:
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No patient acceptance.
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Contraindications for nerve block (coagulopathy, local anesthetics allergy, sepsis, infection at the site of puncture).
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Neuropathy or myopathy affecting the lower limb.
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Psychiatric or neurological diseases that alter the evaluation of patient.
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Arrhythmias.
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Heart failure.
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Diabetes Mellitus.
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Pregnancy.
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Language barriers.
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Anticoagulation.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital Pablo Tobón Uribe | Medellín | Antioquia | Colombia | 050034 |
| 2 | Clínica CES | Medellín | Antioquia | Colombia |
Sponsors and Collaborators
- CES University
- Hospital Pablo Tobón Uribe
- Clínica CES
Investigators
- Principal Investigator: Marta I Berrio, MD, CES University, Medellín, Antioquia, Colombia
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IACES