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

NCT ID: NCT01734954

Last Updated: 2013-04-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2013-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Sciatic nerve blockade at bifurcation

Ultrasound-guided block at the bifurcation of the sciatic nerve

Group Type EXPERIMENTAL

Sciatic nerve anesthesia blockade at bifurcation.

Intervention Type PROCEDURE

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.

Levobupivacaine 0.5%: 20 ml

Intervention Type DRUG

Levobupivacaine is a local anesthetic that is commonly use for anesthesia nerve blockade.

Portable Ultrasound Machine: Sonosite, M-Turbo, Bothell, WA

Intervention Type DEVICE

An ultrasound machine is a device that is widely used for the correct placement of the local anesthetic for anesthesia nerve blockade.

Insulated Needle, (Stimuplex; Braun, Melsungen, Germany)

Intervention Type DEVICE

This is a specific kind of needle that is widely used for anesthesia nerve blockade.

supplemental oxygen

Intervention Type DRUG

supplemental oxygen during the block and/or during surgery

Midazolam

Intervention Type DRUG

Intravenous midazolam for sedation during the block and/or during surgery

Intravenous analgesics

Intervention Type DRUG

Intraoperative administration intravenous of dipyrone 30-50 mg/Kg and or intravenous ketoprofen 100 mg or diclofenac 75 mg or ketorolac 30 mg

Saphenous nerve block

Intervention Type PROCEDURE

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).

Sciatic block 2 cm beyond bifurcation

Ultrasound-guided block of the sciatic nerve 2 cm beyond of the bifurcation

Group Type EXPERIMENTAL

Sciatic nerve blockade 2 cm beyond the bifurcation

Intervention Type PROCEDURE

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 0.5%: 20 ml

Intervention Type DRUG

Levobupivacaine is a local anesthetic that is commonly use for anesthesia nerve blockade.

Portable Ultrasound Machine: Sonosite, M-Turbo, Bothell, WA

Intervention Type DEVICE

An ultrasound machine is a device that is widely used for the correct placement of the local anesthetic for anesthesia nerve blockade.

Insulated Needle, (Stimuplex; Braun, Melsungen, Germany)

Intervention Type DEVICE

This is a specific kind of needle that is widely used for anesthesia nerve blockade.

supplemental oxygen

Intervention Type DRUG

supplemental oxygen during the block and/or during surgery

Midazolam

Intervention Type DRUG

Intravenous midazolam for sedation during the block and/or during surgery

Intravenous analgesics

Intervention Type DRUG

Intraoperative administration intravenous of dipyrone 30-50 mg/Kg and or intravenous ketoprofen 100 mg or diclofenac 75 mg or ketorolac 30 mg

Saphenous nerve block

Intervention Type PROCEDURE

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).

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Levobupivacaine 0.5%: 20 ml

Levobupivacaine is a local anesthetic that is commonly use for anesthesia nerve blockade.

Intervention Type DRUG

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.

Intervention Type DEVICE

Insulated Needle, (Stimuplex; Braun, Melsungen, Germany)

This is a specific kind of needle that is widely used for anesthesia nerve blockade.

Intervention Type DEVICE

supplemental oxygen

supplemental oxygen during the block and/or during surgery

Intervention Type DRUG

Midazolam

Intravenous midazolam for sedation during the block and/or during surgery

Intervention Type 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

Intervention Type DRUG

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).

Intervention Type PROCEDURE

Other Intervention Names

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Sciatic Nerve Block Sciatic nerve block Local Anesthetic Ultrasound Nerve blockade needle short bevel. oxygen

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Pablo Tobón Uribe

OTHER

Sponsor Role collaborator

Clínica CES

UNKNOWN

Sponsor Role collaborator

CES University

OTHER

Sponsor Role lead

Responsible Party

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Marta Inés Berrío Valencia

Anesthesiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marta I Berrio, MD

Role: PRINCIPAL_INVESTIGATOR

CES University, Medellín, Antioquia, Colombia

Locations

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Hospital Pablo Tobón Uribe

Medellín, Antioquia, Colombia

Site Status

Clínica CES

Medellín, Antioquia, Colombia

Site Status

Countries

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Colombia

Central Contacts

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Marta I Berrio, MD

Role: CONTACT

+57 301 4839308

Juan-Felipe Vargas, MD

Role: CONTACT

+57 311 6306919

Facility Contacts

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Marta I Berrio, MD

Role: primary

+57 3014839308

Other Identifiers

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IACES

Identifier Type: -

Identifier Source: org_study_id

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