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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2013 by CES University
Sponsor:
Collaborators:
Hospital Pablo Tobón Uribe
Clínica CES
Information provided by (Responsible Party):
Marta Inés Berrío Valencia, CES University
ClinicalTrials.gov Identifier:
NCT01734954
First received: November 10, 2012
Last updated: April 17, 2013
Last verified: April 2013
  Purpose

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 Intervention
Anesthesia
Procedure: Sciatic nerve anesthesia blockade at bifurcation.
Procedure: Sciatic nerve blockade 2 cm beyond the 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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by CES University:

Primary Outcome Measures:
  • Latency period of sciatic nerve block. [ Time Frame: 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes and 30 minutes after nerve block. ] [ Designated as safety issue: No ]
    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 [ 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. ] [ Designated as safety issue: No ]
    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 [ Time Frame: Postoperative 24 hours ] [ Designated as safety issue: No ]
    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 [ Time Frame: 5, 10, 15, 20, 25 and 30 minutes after the block is finished ] [ Designated as safety issue: No ]

    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

  • Motor block [ Time Frame: 5, 10, 15, 20, 25 and 30 minutes of completion after the block is finished ] [ Designated as safety issue: No ]

    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

  • First analgesic [ Time Frame: 5 minutes, 30 minutes, 24 hours postoperative ] [ Designated as safety issue: No ]
    Time of first analgesic requirement in postoperative

  • Visual analog scale at rest [ Time Frame: 5 minutes, 30 minutes, 24 hours postoperative ] [ Designated as safety issue: No ]
    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 [ Time Frame: 5 minutes, 30 minutes, 24 hours postoperative ] [ Designated as safety issue: No ]
    Pain rating ranging from zero to ten with the movement

  • Intraneural injection [ Time Frame: At the time of injection and execution of the block ] [ Designated as safety issue: Yes ]
    Increased diameter nerve or visualized by ultrasound visualization of the needle into the nerve at the time of injection

  • Vascular puncture [ Time Frame: During the execution of the block ] [ Designated as safety issue: Yes ]
    Puncture of one or more blood vessels to visualize the needle within the vessel or to aspirate blood during block

  • Paresthesia during the procedure [ Time Frame: At the time of the execution of the block ] [ Designated as safety issue: Yes ]
    Paresthesia during the procedure

  • Systemic toxicity of local anesthetics [ Time Frame: During the execution of the block and 30 minutes after it ] [ Designated as safety issue: Yes ]
    Systemic toxicity of local anesthetics

  • Hematoma [ Time Frame: During and inmmediately after the execution of the block ] [ Designated as safety issue: Yes ]
    Hematoma

  • Muscle weakness [ Time Frame: 24 hours postoperative ] [ Designated as safety issue: Yes ]
    Subjective reduction in muscle strength at 24 hours postoperative

  • Altered sensitivity [ Time Frame: 24 hours postoperative ] [ Designated as safety issue: Yes ]
    Subjective decreased sensitivity at 24 hours postoperative

  • Cramps postoperative [ Time Frame: 24 hours postoperative of the block ] [ Designated as safety issue: Yes ]
    Feeling cramps within 24 hours of the block

  • Punctures [ Time Frame: During the block ] [ Designated as safety issue: No ]
    Number of skin punctures during the block

  • Time for the execution of nerve block [ Time Frame: In minutes: Time from placement of the transducer for the initial scan to final withdrawal of the needle ] [ Designated as safety issue: No ]
    Time from placement of the transducer for the initial scan to final withdrawal of the needle


Estimated Enrollment: 66
Study Start Date: April 2013
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Sciatic Nerve Block
Drug: Levobupivacaine 0.5%: 20 ml
Levobupivacaine is a local anesthetic that is commonly use for anesthesia nerve blockade.
Other Name: 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 Name: Ultrasound
Device: Insulated Needle, (Stimuplex; Braun, Melsungen, Germany)
This is a specific kind of needle that is widely used for anesthesia nerve blockade.
Other Name: Nerve blockade needle short bevel.
Drug: supplemental oxygen
supplemental oxygen during the block and/or during surgery
Other Name: 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
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 Name: Sciatic nerve block
Drug: Levobupivacaine 0.5%: 20 ml
Levobupivacaine is a local anesthetic that is commonly use for anesthesia nerve blockade.
Other Name: 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 Name: Ultrasound
Device: Insulated Needle, (Stimuplex; Braun, Melsungen, Germany)
This is a specific kind of needle that is widely used for anesthesia nerve blockade.
Other Name: Nerve blockade needle short bevel.
Drug: supplemental oxygen
supplemental oxygen during the block and/or during surgery
Other Name: 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).

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01734954

Contacts
Contact: Marta I Berrio, MD +57 301 4839308 martaberrio@gmail.com
Contact: Juan-Felipe Vargas, MD +57 311 6306919 vargasj@une.net.co

Locations
Colombia
Hospital Pablo Tobón Uribe Recruiting
Medellín, Antioquia, Colombia, 050034
Contact: Marta I Berrio, MD    +57 3014839308    martaberrio@gmail.com   
Principal Investigator: Marta I Berrio, MD         
Sub-Investigator: Juan-Felipe Vargas, MD         
Clínica CES Active, not recruiting
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
  More Information

Additional Information:
No publications provided

Responsible Party: Marta Inés Berrío Valencia, Anesthesiologist, CES University
ClinicalTrials.gov Identifier: NCT01734954     History of Changes
Other Study ID Numbers: IACES
Study First Received: November 10, 2012
Last Updated: April 17, 2013
Health Authority: Colombia: National Institutes of Health

Keywords provided by CES University:
Hallux Valgus
Nerve block
Sciatic nerve
Ultrasonography
Orthopedics
Amputation
Arthrodesis
Arthroscopy
Fracture fixation
Osteotomy
Tendon transfer
Tenodesis
Tenotomy
Orthopedic procedure

Additional relevant MeSH terms:
Analgesics
Anesthetics
Midazolam
Levobupivacaine
Bupivacaine
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Adjuvants, Anesthesia
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 26, 2014