Clinical trial NCT01734954: Comparison of Two Techniques of Sciatic Nerve Block With Levobupivacaine 0.5% in Orthopedic Surgery
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anesthesia
Keywords: Nerve block
Sciatic nerve
Ultrasonography
Orthopedics
Hallux Valgus
Amputation
Arthrodesis
Arthroscopy
Fracture fixation
Osteotomy
Tendon transfer
Tenodesis
Tenotomy
Orthopedic procedure
Lead sponsor: CES University
Sponsor class: OTHER
Collaborators: name: Hospital Pablo Tobón Uribe
name: Clínica CES
First posted: 2012-11-28
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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.

Primary outcomes:
measure: Latency period of sciatic nerve block.
timeFrame: 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes and 30 minutes after nerve block.
Secondary outcomes:
measure: Success of sciatic nerve block
timeFrame: 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.
measure: Patient satisfaction
timeFrame: Postoperative 24 hours
measure: Sensory block
timeFrame: 5, 10, 15, 20, 25 and 30 minutes after the block is finished
measure: Motor block
timeFrame: 5, 10, 15, 20, 25 and 30 minutes of completion after the block is finished
measure: First analgesic
timeFrame: 5 minutes, 30 minutes, 24 hours postoperative
measure: Visual analog scale at rest
timeFrame: 5 minutes, 30 minutes, 24 hours postoperative
measure: Dynamic visual analog scale
timeFrame: 5 minutes, 30 minutes, 24 hours postoperative
measure: Intraneural injection
timeFrame: At the time of injection and execution of the block
measure: Vascular puncture
timeFrame: During the execution of the block
measure: Paresthesia during the procedure
timeFrame: At the time of the execution of the block
measure: Systemic toxicity of local anesthetics
timeFrame: During the execution of the block and 30 minutes after it
measure: Hematoma
timeFrame: During and inmmediately after the execution of the block
measure: Muscle weakness
timeFrame: 24 hours postoperative
measure: Altered sensitivity
timeFrame: 24 hours postoperative
measure: Cramps postoperative
timeFrame: 24 hours postoperative of the block
measure: Punctures
timeFrame: During the block
measure: Time for the execution of nerve block
timeFrame: In minutes: Time from placement of the transducer for the initial scan to final withdrawal of the needle
Other outcomes:
Locations:
city: Medellín
country: Colombia
facility: Hospital Pablo Tobón Uribe
state: Antioquia
city: Medellín
country: Colombia
facility: Clínica CES
state: Antioquia
Study officials:
affiliation: CES University, Medellín, Antioquia, Colombia
name: Marta I Berrio, MD
role: PRINCIPAL_INVESTIGATOR
References: