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

NCT ID: NCT02124005

Last Updated: 2017-08-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2015-09-30

Brief 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.

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.

Conditions

Knee Surgery; Postoperative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Femoral block, ultrasound, bupivacaine

Group Type: EXPERIMENTAL

Bupivacaine

Intervention Type: DRUG

Interventions

Bupivacaine

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• patients to undergo knee surgery

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ed Carlos Rey Moura

OTHER

Sponsor Role: lead

Responsible Party

Ed Carlos Rey Moura

doctor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Ed Carlos Moura, research

Role: PRINCIPAL_INVESTIGATOR

Federal University of São Paulo

Locations

Universidade Federal de São Paulo

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

EC50 femoral block bupivacaine

Identifier Type: -

Identifier Source: org_study_id