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

NCT01734954 | Unknown

• 1 other identifier: IACES
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 2

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.

Conditions

Anesthesia

Keywords

Nerve block; Sciatic nerve; Ultrasonography; Orthopedics; Hallux Valgus; Amputation; Arthrodesis; Arthroscopy; Fracture fixation; Osteotomy; Tendon transfer; Tenodesis; Tenotomy; Orthopedic procedure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (17)

• 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.

• Patient satisfaction

  Postoperative 24 hours

• Sensory block

  5, 10, 15, 20, 25 and 30 minutes after the block is finished

• Motor block

  5, 10, 15, 20, 25 and 30 minutes of completion after the block is finished

• First analgesic

  5 minutes, 30 minutes, 24 hours postoperative

Study Arms (2)

Sciatic nerve blockade at bifurcation

EXPERIMENTAL

Ultrasound-guided block at the bifurcation of the sciatic nerve

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

Sciatic block 2 cm beyond bifurcation

EXPERIMENTAL

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

Interventions

Sciatic nerve anesthesia blockade at bifurcation. 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.

Also known as: Sciatic Nerve Block

Sciatic nerve blockade at bifurcation

Sciatic nerve blockade 2 cm beyond the bifurcation 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.

Also known as: Sciatic nerve block

Sciatic block 2 cm beyond bifurcation

Levobupivacaine 0.5%: 20 ml DRUG

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

Also known as: Local Anesthetic

Sciatic block 2 cm beyond bifurcation; Sciatic nerve blockade at bifurcation

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

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

Also known as: Ultrasound

Sciatic block 2 cm beyond bifurcation; Sciatic nerve blockade at bifurcation

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

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

Also known as: Nerve blockade needle short bevel.

Sciatic block 2 cm beyond bifurcation; Sciatic nerve blockade at bifurcation

supplemental oxygen DRUG

supplemental oxygen during the block and/or during surgery

Also known as: oxygen

Sciatic block 2 cm beyond bifurcation; Sciatic nerve blockade at bifurcation

Midazolam DRUG

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

Sciatic block 2 cm beyond bifurcation; Sciatic nerve blockade at bifurcation

Intravenous analgesics DRUG

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

Sciatic block 2 cm beyond bifurcation; Sciatic nerve blockade at bifurcation

Saphenous nerve block 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; Sciatic nerve blockade at bifurcation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CES University: lead
• Hospital Pablo Tobón Uribe: collaborator
• Clínica CES: collaborator

Study Sites (2)

Hospital Pablo Tobón Uribe

Medellín, Antioquia, 050034, Colombia

Location

Clínica CES

Medellín, Antioquia, Colombia

Location

MeSH Terms

Conditions

Hallux Valgus; Ankylosis

Interventions

Levobupivacaine; Anesthetics, Local; Ultrasonography; Oxygen; Midazolam

Condition Hierarchy (Ancestors)

Foot Deformities; Musculoskeletal Diseases; Joint Diseases

Intervention Hierarchy (Ancestors)

Bupivacaine; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Chalcogens; Elements; Inorganic Chemicals; Gases; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Marta I Berrio, MD

  CES University, Medellín, Antioquia, Colombia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marta I Berrio, MD

CONTACT

+57 301 4839308; martaberrio@gmail.com

Juan-Felipe Vargas, MD

CONTACT

+57 311 6306919; vargasj@une.net.co

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist

Study Record Dates

• First Submitted: November 10, 2012
• First Posted: November 28, 2012
• Study Start: April 1, 2013
• Primary Completion: August 1, 2013
• Study Completion: September 1, 2013
• Last Updated: April 19, 2013

Record last verified: 2013-04

Locations

CO (2)