Evaluation of the Minimum Effective Concentration of Bupivacaine (EC50) in Femoral Block for Analgesia by Ultrasound After Knee Surgery

July 29, 2017 updated by: Ed Carlos Rey Moura
The purpose of the study is to determine the minimum effective concentration of bupivacaine (EC50) in femoral block for analgesia by ultrasound after knee surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

45 patients classified as ASA P1 or P2 aged between 18 and 65 candidates for elective knee operation via arthroscopy were included in the study. All patients received femoral nerve block guided by ultrasound with bupivacaine, 22 ml. The first patient at a concentration of 0.25%. The other patients with higher or lower concentrations if the first patient has pain> 3 or <3 on visual analogic scale respectively after awakening of surgical anesthesia. For surgical anesthesia each patient will undergo general anesthesia. At the end of the surgical procedure and anesthetic awakening patients will be evaluated for analgesia by verbal numeric scale. The modified Dixon method was used to find the EC50 and EC95 of bupivacaine for analgesia of femoral nerve block guided by ultrasound. Concentration still correlated with motor block and side effects.

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • São Paulo, SP, Brazil, 04023-061
        • Universidade Federal de Sao Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients to undergo knee surgery

Exclusion Criteria:

  • patients with coagulopathy
  • pregnant
  • infection at the puncture site
  • chronic pain

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Femoral block, ultrasound, bupivacaine
Drug: Bupivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Scores on the Visual Analog Scale
Time Frame: two years
45 patients classified as ASA P1 or P2 aged between 18 and 65 candidates for elective knee operation via arthroscopy were included in the study. All patients received femoral nerve block guided by ultrasound with bupivacaine, 22 ml. The first patient at a concentration of 0.25%. The other patients with higher or lower concentrations if the first patient has pain> 3 or <3 on visual analogic scale respectively after awakening of surgical anesthesia. For surgical anesthesia each patient will undergo general anesthesia. At the end of the surgical procedure and anesthetic awakening patients will be evaluated for analgesia by verbal numeric scale. The modified Dixon method was used to find the EC50 and EC95 of bupivacaine for analgesia of femoral nerve block guided by ultrasound. Concentration still correlated with motor block and side effects.
two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ed Carlos Rey Moura

Investigators

  • Principal Investigator: Ed Carlos Moura, research, Federal University of São Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2013

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

April 13, 2014

First Submitted That Met QC Criteria

April 24, 2014

First Posted (Estimate)

April 28, 2014

Study Record Updates

Last Update Posted (Actual)

August 1, 2017

Last Update Submitted That Met QC Criteria

July 29, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EC50 femoral block bupivacaine

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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