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

NCT ID: NCT03815565

Last Updated: 2020-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-28

Study Completion Date

2021-01-08

Brief Summary

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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

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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.

Conditions

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Femur Fracture Hip Fractures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
Only the pharmacist chief knows which participant belongs to each arm

Study Groups

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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

Group Type EXPERIMENTAL

continuous femoral block

Intervention Type PROCEDURE

infusion of anesthetic by PCA pump

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

Group Type ACTIVE_COMPARATOR

continuous femoral block

Intervention Type PROCEDURE

infusion of anesthetic by PCA pump

Interventions

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continuous femoral block

infusion of anesthetic by PCA pump

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hospital Municipal Miguel Couto

OTHER

Sponsor Role lead

Responsible Party

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Rafael Mercante Linhares

Head of Anesthesiology and Pain Medicine Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Rafael M Linhares

Rio de Janeiro, , Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Rafael Linhares

Role: CONTACT

+55 21 981436088

Ismar Cavalcanti

Role: CONTACT

+55 21 999822993

Facility Contacts

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Rafael Linhares

Role: primary

+55 21 981436088

Ismar Cavalcanti

Role: backup

+55 21 999822993

References

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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.

Reference Type BACKGROUND
PMID: 27871587 (View on PubMed)

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.

Reference Type RESULT
PMID: 26330019 (View on PubMed)

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.

Reference Type RESULT
PMID: 12791436 (View on PubMed)

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.

Reference Type RESULT
PMID: 24764520 (View on PubMed)

Other Identifiers

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65821217.5.0000.8066

Identifier Type: -

Identifier Source: org_study_id

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