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

Comparison of Two Techniques of Ultrasound-guided Sciatic Nerve Block Using Levobupivacaine 0.5% in Orthopedic Surgery at the Hospital Pablo Tobon Uribe - Clínica CES, 2013, Randomized Clinical Trial

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Anticipated): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Colombia
  • Antioquia
    • Medellín, Antioquia, Colombia, 050034
      • Hospital Pablo Tobón Uribe
    • Medellín, Antioquia, Colombia
      • Clinica Ces

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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: Sciatic Nerve Block; Drug: Levobupivacaine 0.5%: 20 ml; Levobupivacaine is a local anesthetic that is commonly use for anesthesia nerve blockade.; Other Names: Local Anesthetic; 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: Ultrasound; Device: Insulated Needle, (Stimuplex; Braun, Melsungen, Germany); This is a specific kind of needle that is widely used for anesthesia nerve blockade.; Other Names: Nerve blockade needle short bevel.; Drug: supplemental oxygen; supplemental oxygen during the block and/or during surgery; Other Names: oxygen; 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).
Experimental: Sciatic block 2 cm beyond bifurcation; Ultrasound-guided block of the sciatic nerve 2 cm beyond of the bifurcation	Drug: Levobupivacaine 0.5%: 20 ml; Levobupivacaine is a local anesthetic that is commonly use for anesthesia nerve blockade.; Other Names: Local Anesthetic; 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: Ultrasound; Device: Insulated Needle, (Stimuplex; Braun, Melsungen, Germany); This is a specific kind of needle that is widely used for anesthesia nerve blockade.; Other Names: Nerve blockade needle short bevel.; Drug: supplemental oxygen; supplemental oxygen during the block and/or during surgery; Other Names: oxygen; 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).; 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: Sciatic nerve block

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes and 30 minutes after nerve block.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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; 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	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; Motor block almost complete; No motor block (for the tibial component for plantarflexion and dorsiflexion with the common peroneal) compared with the contralateral leg	5, 10, 15, 20, 25 and 30 minutes of completion after the block is finished
First analgesic	Time of first analgesic requirement in postoperative	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	5 minutes, 30 minutes, 24 hours postoperative
Dynamic visual analog scale	Pain rating ranging from zero to ten with the movement	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	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	During the execution of the block
Paresthesia during the procedure	Paresthesia during the procedure	At the time of the execution of the block
Systemic toxicity of local anesthetics	Systemic toxicity of local anesthetics	During the execution of the block and 30 minutes after it
Hematoma	Hematoma	During and inmmediately after the execution of the block
Muscle weakness	Subjective reduction in muscle strength at 24 hours postoperative	24 hours postoperative
Altered sensitivity	Subjective decreased sensitivity at 24 hours postoperative	24 hours postoperative
Cramps postoperative	Feeling cramps within 24 hours of the block	24 hours postoperative of the block
Punctures	Number of skin punctures during the block	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	In minutes: Time from placement of the transducer for the initial scan to final withdrawal of the needle

Collaborators and Investigators

• Sponsor: CES University
• Collaborators: Hospital Pablo Tobón Uribe; Clinica CES
• Investigators: Principal Investigator: Marta I Berrio, MD, CES University, Medellín, Antioquia, Colombia

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Anticipated): August 1, 2013
• Study Completion (Anticipated): September 1, 2013

Study Registration Dates

• First Submitted: November 10, 2012
• First Submitted That Met QC Criteria: November 27, 2012
• First Posted (Estimate): November 28, 2012

Study Record Updates

• Last Update Posted (Estimate): April 19, 2013
• Last Update Submitted That Met QC Criteria: April 17, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Keywords: Ultrasonography; Amputation; Arthroscopy; Orthopedics; Hallux Valgus; Nerve block; Arthrodesis; Sciatic nerve; Osteotomy; Fracture fixation; Tenotomy; Tendon transfer; Tenodesis; Orthopedic procedure
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Anesthetics; Midazolam; Anesthetics, Local; Levobupivacaine; Analgesics
• Other Study ID Numbers: IACES