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Clinical Trials/NCT01734954
NCT01734954
Unknown
Not Applicable

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

CES University2 sites in 1 country66 target enrollmentApril 2013

Overview

Phase
Not Applicable
Intervention
Sciatic nerve anesthesia blockade at bifurcation.
Conditions
Anesthesia
Sponsor
CES University
Enrollment
66
Locations
2
Primary Endpoint
Latency period of sciatic nerve block.
Last Updated
13 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2013
End Date
September 2013
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
CES University
Responsible Party
Principal Investigator
Principal Investigator

Marta Inés Berrío Valencia

Anesthesiologist

CES University

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-
  • 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.

Arms & Interventions

Sciatic nerve blockade at bifurcation

Ultrasound-guided block at the bifurcation of the sciatic nerve

Intervention: Sciatic nerve anesthesia blockade at bifurcation.

Sciatic nerve blockade at bifurcation

Ultrasound-guided block at the bifurcation of the sciatic nerve

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

Sciatic nerve blockade at bifurcation

Ultrasound-guided block at the bifurcation of the sciatic nerve

Intervention: supplemental oxygen

Sciatic nerve blockade at bifurcation

Ultrasound-guided block at the bifurcation of the sciatic nerve

Intervention: Midazolam

Sciatic nerve blockade at bifurcation

Ultrasound-guided block at the bifurcation of the sciatic nerve

Intervention: Intravenous analgesics

Sciatic nerve blockade at bifurcation

Ultrasound-guided block at the bifurcation of the sciatic nerve

Intervention: Saphenous nerve block

Sciatic block 2 cm beyond bifurcation

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

Intervention: Sciatic nerve blockade 2 cm beyond the bifurcation

Sciatic block 2 cm beyond bifurcation

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

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

Sciatic block 2 cm beyond bifurcation

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

Intervention: supplemental oxygen

Sciatic block 2 cm beyond bifurcation

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

Intervention: Midazolam

Sciatic block 2 cm beyond bifurcation

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

Intervention: Intravenous analgesics

Sciatic block 2 cm beyond bifurcation

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

Intervention: Saphenous nerve block

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • 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)
  • Visual analog scale at rest(5 minutes, 30 minutes, 24 hours postoperative)
  • Dynamic visual analog scale(5 minutes, 30 minutes, 24 hours postoperative)
  • Intraneural injection(At the time of injection and execution of the block)
  • Vascular puncture(During the execution of the block)
  • Paresthesia during the procedure(At the time of the execution of the block)
  • Systemic toxicity of local anesthetics(During the execution of the block and 30 minutes after it)
  • Hematoma(During and inmmediately after the execution of the block)
  • Muscle weakness(24 hours postoperative)
  • Altered sensitivity(24 hours postoperative)
  • Cramps postoperative(24 hours postoperative of the block)
  • Punctures(During the block)
  • Time for the execution of nerve block(In minutes: Time from placement of the transducer for the initial scan to final withdrawal of the needle)

Study Sites (2)

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