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

NCT01734954 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2013-04-19

No results posted yet for this study

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

Interventions

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.

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.

DRUG

Levobupivacaine 0.5%: 20 ml

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

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.

DEVICE

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

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

DRUG

supplemental oxygen

supplemental oxygen during the block and/or during surgery

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).

Sponsors & Collaborators

  • Hospital Pablo Tobón Uribe

    collaborator OTHER
  • Clínica CES

    collaborator UNKNOWN
  • CES University

    lead OTHER

Principal Investigators

  • Marta I Berrio, MD · CES University, Medellín, Antioquia, Colombia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2013-08-31
Completion
2013-09-30

Countries

  • Colombia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01734954 on ClinicalTrials.gov