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

April 17, 2013 updated by: Marta Inés Berrío Valencia, CES University

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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
66

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Latency period of sciatic nerve block.
Time Frame: 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.
5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes and 30 minutes after nerve block.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
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
Time Frame: 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.
Postoperative 24 hours
Sensory block
Time Frame: 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 leg
5, 10, 15, 20, 25 and 30 minutes after the block is finished
Motor block
Time Frame: 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 leg
5, 10, 15, 20, 25 and 30 minutes of completion after the block is finished
First analgesic
Time Frame: 5 minutes, 30 minutes, 24 hours postoperative
Time of first analgesic requirement in postoperative
5 minutes, 30 minutes, 24 hours postoperative
Visual analog scale at rest
Time Frame: 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
5 minutes, 30 minutes, 24 hours postoperative
Dynamic visual analog scale
Time Frame: 5 minutes, 30 minutes, 24 hours postoperative
Pain rating ranging from zero to ten with the movement
5 minutes, 30 minutes, 24 hours postoperative
Intraneural injection
Time Frame: 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
At the time of injection and execution of the block
Vascular puncture
Time Frame: 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
During the execution of the block
Paresthesia during the procedure
Time Frame: At the time of the execution of the block
Paresthesia during the procedure
At the time of the execution of the block
Systemic toxicity of local anesthetics
Time Frame: During the execution of the block and 30 minutes after it
Systemic toxicity of local anesthetics
During the execution of the block and 30 minutes after it
Hematoma
Time Frame: During and inmmediately after the execution of the block
Hematoma
During and inmmediately after the execution of the block
Muscle weakness
Time Frame: 24 hours postoperative
Subjective reduction in muscle strength at 24 hours postoperative
24 hours postoperative
Altered sensitivity
Time Frame: 24 hours postoperative
Subjective decreased sensitivity at 24 hours postoperative
24 hours postoperative
Cramps postoperative
Time Frame: 24 hours postoperative of the block
Feeling cramps within 24 hours of the block
24 hours postoperative of the block
Punctures
Time Frame: During the block
Number of skin punctures during the block
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
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
CES University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Hospital Pablo Tobón Uribe
Clinica CES

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Marta I Berrio, MD, CES University, Medellín, Antioquia, Colombia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2013

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2013

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 10, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 27, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 28, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 19, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 17, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IACES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings