Back to resultsEvaluation of the Minimum Effective Concentration of Bupivacaine (EC50) in Femoral Block for Analgesia by Ultrasound After Knee Surgery
Primary Purpose
Knee Surgery, Postoperative Pain
Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Bupivacaine
Sponsored by
About this trial
This is an interventional treatment trial for Knee Surgery focused on measuring Knee surgery, Femoral block, Bupivacaine, Ultrasound
Eligibility Criteria
Inclusion Criteria:
- patients to undergo knee surgery
Exclusion Criteria:
- patients with coagulopathy
- pregnant
- infection at the puncture site
- chronic pain
Sites / Locations
- Universidade Federal de São Paulo
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Femoral block, ultrasound, bupivacaine
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02124005
Brief Title
Evaluation of the Minimum Effective Concentration of Bupivacaine (EC50) in Femoral Block for Analgesia by Ultrasound After Knee Surgery
Official Title
Evaluation of the Minimum Effective Concentration of Bupivacaine (EC50) in Femoral Block for Analgesia by Ultrasound After Knee Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
July 2013 (Actual)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
September 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ed Carlos Rey Moura
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Surgery, Postoperative Pain
Keywords
Knee surgery, Femoral block, Bupivacaine, Ultrasound
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Femoral block, ultrasound, bupivacaine
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Primary Outcome Measure Information:
Title
Pain Scores on the Visual Analog Scale
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.
Time Frame
two years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
patients to undergo knee surgery
Exclusion Criteria:
patients with coagulopathy
pregnant
infection at the puncture site
chronic pain
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ed Carlos Moura, research
Organizational Affiliation
Federal University of São Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidade Federal de São Paulo
City
São Paulo
State/Province
SP
ZIP/Postal Code
04023-061
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Evaluation of the Minimum Effective Concentration of Bupivacaine (EC50) in Femoral Block for Analgesia by Ultrasound After Knee Surgery
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