Continuous Femoral Block With Levobupivacaine 0.125% or Ropivacaine 0.2% in Elderly Patients With Femoral Fractures

February 18, 2020 updated by: Rafael Mercante Linhares, Hospital Municipal Miguel Couto

Comparison Between Continuous Femoral Block With Levobupivacaine 0.125% and Ropivacaine 0.2% for Preoperative Analgesia, in Patients Over 70 Years Old, With Proximal Femoral Fractures: a Randomized, Double-blind Study

This study evaluates the continuous femoral block between levobupivacaine 0.125% and ropivacaine 0.2% in patients with proximal femoral fracture.These patients will be divided into 2 groups of 35 patients, one L group (levobupivacaine 0.125%) and one R group (ropivacaine 0.2%) distributed randomly, receiving continuous infusion through patient controlled analgesia (PCA) pump with the following parameters: infusion 5 ml / h, bolus 5 ml, lockout 30 min.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Pain is associated with neurohormonal stress, myocardial ischemia and delayed mobilization, thus being able to increase the hospitalization time and associated with increased postoperative mortality. Regional anesthesia through simple or continuous femoral nerve block are options for analgesia in patients with femoral fracture, as well as analgesia by venous opioids. A potential benefit of regional anesthesia is precisely to avoid the use of opioids and other general anesthetics, which in turn are also closely related to postoperative delirium. Continuous femoral block, since the preoperative period, is associated with the reduction of acute pain and opioid consumption, in patients with femoral neck fractures. There are few studies available in the literature comparing analgesic equipotency between levobupivacaine and ropivacaine in peripheral nerve blocks. In none of them, the peripheral analgesia in the femoral nerve, for proximal femoral fracture was compared.

Study Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

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

70 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 70 years old or more
  • patients with femur fracture
  • physical status risk American Society of Anesthesiologists (ASA) P1 - P3

Exclusion Criteria:

  • physical status ASA P4
  • patients with BMI > 35
  • systemic infection
  • Injury or infection at the site of installation of the femoral perineural catheter
  • Catheter displacement of the perineural site
  • Montreal Cognitive Assessment (MoCA) < 26
  • Patients operated before 24 hours of hospital admission

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: levobupivacaine 0.125%
continuous femoral block with levobupivacaine 0.125%. Use of PCA pump with the following parameters: 5 ml/h; bolus 5 ml; lockout 30 minutes
Procedure: continuous femoral block
infusion of anesthetic by PCA pump
Active Comparator: ropivacaine 0.2%
continuous femoral block with ropivacaine 0.2%. Use of PCA pump with the following parameters: 5 ml/h; bolus 5 ml; lockout 30 minutes
Procedure: continuous femoral block
infusion of anesthetic by PCA pump

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
intensity of individual pain episodes
Time Frame: 6 hours after hospital admission
Self report pain intensity in the preoperative period. Scored 0-10 (0 = no pain; 10 = pain as bad as can be)
6 hours after hospital admission

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of PCA firing
Time Frame: 72 hours
in each patient at time of evaluation of pain
72 hours
Degree of satisfaction with analgesic therapy
Time Frame: up to 72 hours - at the moment of surgery; or at the end of 72 hours
using the 5-point rating scale (very dissatisfied, dissatisfied, neutral, satisfied or very pleased)
up to 72 hours - at the moment of surgery; or at the end of 72 hours
Quality of sleep
Time Frame: up to 72 hours
very good, good, bad and very bad
up to 72 hours
the cost of analgesic therapy
Time Frame: up to 72 hours
including catheters, PCA and medication in each patient
up to 72 hours
adverse event
Time Frame: up to 72 hours
paresthesia, nausea, vomiting, ringing in the ear, metallic taste, convulsion or cardiac arrest
up to 72 hours

Collaborators and Investigators

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

Sponsor

Hospital Municipal Miguel Couto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

August 28, 2017

Primary Completion (Anticipated)

August 8, 2020

Study Completion (Anticipated)

January 8, 2021

Study Registration Dates

First Submitted

January 8, 2019

First Submitted That Met QC Criteria

January 21, 2019

First Posted (Actual)

January 24, 2019

Study Record Updates

Last Update Posted (Actual)

February 20, 2020

Last Update Submitted That Met QC Criteria

February 18, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 65821217.5.0000.8066

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

after the finish of the study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Hip Fractures

Clinical Trials on continuous femoral block

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bulgaria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe