NCT03815565

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 28, 2017

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

January 8, 2019

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 24, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 8, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 8, 2021

Completed
Last Updated

February 20, 2020

Status Verified

February 1, 2020

Enrollment Period

2.9 years

First QC Date

January 8, 2019

Last Update Submit

February 18, 2020

Conditions

Femur FractureHip Fractures

Keywords

analgesiacontinuousfemoral block

Outcome Measures

Primary Outcomes (1)

  • 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)

    6 hours after hospital admission

Secondary Outcomes (5)

  • Number of PCA firing

    72 hours

  • Degree of satisfaction with analgesic therapy

    up to 72 hours - at the moment of surgery; or at the end of 72 hours

  • Quality of sleep

    up to 72 hours

  • the cost of analgesic therapy

    up to 72 hours

  • adverse event

    up to 72 hours

Study Arms (2)

levobupivacaine 0.125%

EXPERIMENTAL

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

ropivacaine 0.2%

ACTIVE COMPARATOR

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

Interventions

continuous femoral blockPROCEDURE

infusion of anesthetic by PCA pump

levobupivacaine 0.125%ropivacaine 0.2%

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rafael M Linhares

Rio de Janeiro, 22776050, Brazil

RECRUITING

Related Publications (4)

  • 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.

    PMID: 27871587BACKGROUND

  • 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.

    PMID: 26330019RESULT

  • 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.

    PMID: 12791436RESULT

  • 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.

    PMID: 24764520RESULT

MeSH Terms

Conditions

Femoral FracturesHip FracturesAgnosia

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesLeg InjuriesHip InjuriesPerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Rafael Linhares

CONTACT

+55 21 981436088rafaellinhares@me.com

Ismar Cavalcanti

CONTACT

+55 21 999822993ismarcavalcanti@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Only the pharmacist chief knows which participant belongs to each arm
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: randomized
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Anesthesiology and Pain Medicine Department

Study Record Dates

First Submitted

January 8, 2019

First Posted

January 24, 2019

Study Start

August 28, 2017

Primary Completion

August 8, 2020

Study Completion

January 8, 2021

Last Updated

February 20, 2020

Record last verified: 2020-02

Locations

BR(1)