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

Sponsor

Ed Carlos Rey Moura (Other)

Overall Status

Completed

CT.gov ID

NCT02124005

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Knee Surgery Postoperative Pain	Drug: Bupivacaine	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

45 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 1, 2013

Actual Primary Completion Date :

Jul 1, 2015

Actual Study Completion Date :

Sep 1, 2015

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Femoral block, ultrasound, bupivacaine

Drug: Bupivacaine

Outcome Measures

Primary Outcome Measures

Pain Scores on the Visual Analog Scale [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

patients to undergo knee surgery

Exclusion Criteria:

patients with coagulopathy
pregnant
infection at the puncture site
chronic pain

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Universidade Federal de São Paulo	São Paulo	SP	Brazil	04023-061

Sponsors and Collaborators

Ed Carlos Rey Moura

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ed Carlos Rey Moura, doctor, Federal University of São Paulo

ClinicalTrials.gov Identifier:

NCT02124005

Other Study ID Numbers:

EC50 femoral block bupivacaine

First Posted:

Apr 28, 2014

Last Update Posted:

Aug 1, 2017

Last Verified:

Jul 1, 2017

Keywords provided by Ed Carlos Rey Moura, doctor, Federal University of São Paulo

Additional relevant MeSH terms:

Pain, Postoperative

Bupivacaine

Study Results

No Results Posted as of Aug 1, 2017