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

Hospital Municipal Miguel Couto

Status: Unknown

Conditions: Hip Fractures; Femur Fracture

Treatments: Procedure: continuous femoral block

Study type: Interventional

Funder types: Other

Identifiers

NCT03815565

65821217.5.0000.8066

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 estimated patients

Sex: All

Ages: 70+ years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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70 participants in 2 patient groups

levobupivacaine 0.125%

Experimental group

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

Treatment:

Procedure: continuous femoral block

ropivacaine 0.2%

Active Comparator group

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

Treatment:

Procedure: continuous femoral block