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

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02124005
• Other study ID #: EC50 femoral block bupivacaine
• Status: Completed
• Phase: Phase 4
• First received: April 13, 2014
• Last updated: July 29, 2017
• Start date: July 2013
• Est. completion date: September 2015

Study information

• Verified date: July 2017
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: September 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• patients to undergo knee surgery

Exclusion Criteria:

• patients with coagulopathy

• pregnant

• infection at the puncture site

• chronic pain

Related Conditions & MeSH terms

• Knee Surgery
• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Bupivacaine

Locations

Country	Name	City	State
Brazil	Universidade Federal de São Paulo	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Ed Carlos Rey Moura

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Scores on the Visual Analog Scale	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