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

Primary Purpose

Femur Fracture, Hip Fractures

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
continuous femoral block
Sponsored by
Hospital Municipal Miguel Couto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Femur Fracture focused on measuring analgesia, continuous, femoral block

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Rafael M LinharesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

levobupivacaine 0.125%

ropivacaine 0.2%

Arm Description

continuous femoral block with levobupivacaine 0.125%. Use of PCA pump with the following parameters: 5 ml/h; bolus 5 ml; lockout 30 minutes

continuous femoral block with ropivacaine 0.2%. Use of PCA pump with the following parameters: 5 ml/h; bolus 5 ml; lockout 30 minutes

Outcomes

Primary Outcome Measures

intensity of individual pain episodes
Self report pain intensity in the preoperative period. Scored 0-10 (0 = no pain; 10 = pain as bad as can be)

Secondary Outcome Measures

Number of PCA firing
in each patient at time of evaluation of pain
Degree of satisfaction with analgesic therapy
using the 5-point rating scale (very dissatisfied, dissatisfied, neutral, satisfied or very pleased)
Quality of sleep
very good, good, bad and very bad
the cost of analgesic therapy
including catheters, PCA and medication in each patient
adverse event
paresthesia, nausea, vomiting, ringing in the ear, metallic taste, convulsion or cardiac arrest

Full Information

First Posted
January 8, 2019
Last Updated
February 18, 2020
Sponsor
Hospital Municipal Miguel Couto
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1. Study Identification

Unique Protocol Identification Number
NCT03815565
Brief Title
Continuous Femoral Block With Levobupivacaine 0.125% or Ropivacaine 0.2% in Elderly Patients With Femoral Fractures
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 28, 2017 (Actual)
Primary Completion Date
August 8, 2020 (Anticipated)
Study Completion Date
January 8, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Municipal Miguel Couto

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Femur Fracture, Hip Fractures
Keywords
analgesia, continuous, femoral block

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized
Masking
ParticipantInvestigator
Masking Description
Only the pharmacist chief knows which participant belongs to each arm
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
levobupivacaine 0.125%
Arm Type
Experimental
Arm Description
continuous femoral block with levobupivacaine 0.125%. Use of PCA pump with the following parameters: 5 ml/h; bolus 5 ml; lockout 30 minutes
Arm Title
ropivacaine 0.2%
Arm Type
Active Comparator
Arm Description
continuous femoral block with ropivacaine 0.2%. Use of PCA pump with the following parameters: 5 ml/h; bolus 5 ml; lockout 30 minutes
Intervention Type
Procedure
Intervention Name(s)
continuous femoral block
Intervention Description
infusion of anesthetic by PCA pump
Primary Outcome Measure Information:
Title
intensity of individual pain episodes
Description
Self report pain intensity in the preoperative period. Scored 0-10 (0 = no pain; 10 = pain as bad as can be)
Time Frame
6 hours after hospital admission
Secondary Outcome Measure Information:
Title
Number of PCA firing
Description
in each patient at time of evaluation of pain
Time Frame
72 hours
Title
Degree of satisfaction with analgesic therapy
Description
using the 5-point rating scale (very dissatisfied, dissatisfied, neutral, satisfied or very pleased)
Time Frame
up to 72 hours - at the moment of surgery; or at the end of 72 hours
Title
Quality of sleep
Description
very good, good, bad and very bad
Time Frame
up to 72 hours
Title
the cost of analgesic therapy
Description
including catheters, PCA and medication in each patient
Time Frame
up to 72 hours
Title
adverse event
Description
paresthesia, nausea, vomiting, ringing in the ear, metallic taste, convulsion or cardiac arrest
Time Frame
up to 72 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rafael Linhares
Phone
+55 21 981436088
Email
rafaellinhares@me.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ismar Cavalcanti
Phone
+55 21 999822993
Email
ismarcavalcanti@gmail.com
Facility Information:
Facility Name
Rafael M Linhares
City
Rio de Janeiro
ZIP/Postal Code
22776050
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rafael Linhares
Phone
+55 21 981436088
Email
rafaellinhares@me.com
First Name & Middle Initial & Last Name & Degree
Ismar Cavalcanti
Phone
+55 21 999822993
Email
ismarcavalcanti@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
after the finish of the study
Citations:
PubMed Identifier
27871587
Citation
Joshi G, Gandhi K, Shah N, Gadsden J, Corman SL. Peripheral nerve blocks in the management of postoperative pain: challenges and opportunities. J Clin Anesth. 2016 Dec;35:524-529. doi: 10.1016/j.jclinane.2016.08.041. Epub 2016 Oct 20.
Results Reference
background
PubMed Identifier
26330019
Citation
Ritcey B, Pageau P, Woo MY, Perry JJ. Regional Nerve Blocks For Hip and Femoral Neck Fractures in the Emergency Department: A Systematic Review. CJEM. 2016 Jan;18(1):37-47. doi: 10.1017/cem.2015.75. Epub 2015 Sep 2.
Results Reference
result
PubMed Identifier
12791436
Citation
Morrison SR, Magaziner J, McLaughlin MA, Orosz G, Silberzweig SB, Koval KJ, Siu AL. The impact of post-operative pain on outcomes following hip fracture. Pain. 2003 Jun;103(3):303-311. doi: 10.1016/S0304-3959(02)00458-X.
Results Reference
result
PubMed Identifier
24764520
Citation
Szucs S, Iohom G, O'Donnell B, Sajgalik P, Ahmad I, Salah N, Shorten G. Analgesic efficacy of continuous femoral nerve block commenced prior to operative fixation of fractured neck of femur. Perioper Med (Lond). 2012 Jun 27;1:4. doi: 10.1186/2047-0525-1-4. eCollection 2012.
Results Reference
result

Learn more about this trial

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

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