Femur Fracture, Hip Fractures
Conditions
Keywords
analgesia, continuous, femoral block
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.
Interventions
PROCEDUREcontinuous femoral block
infusion of anesthetic by PCA pump
Sponsors
Hospital Municipal Miguel Couto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Only the pharmacist chief knows which participant belongs to each arm
Intervention model description
randomized
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| intensity of individual pain episodes | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of PCA firing | 72 hours | in each patient at time of evaluation of pain |
| Degree of satisfaction with analgesic therapy | 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) |
| Quality of sleep | up to 72 hours | very good, good, bad and very bad |
| the cost of analgesic therapy | up to 72 hours | including catheters, PCA and medication in each patient |
| adverse event | up to 72 hours | paresthesia, nausea, vomiting, ringing in the ear, metallic taste, convulsion or cardiac arrest |
Countries
Brazil
Contacts
Primary ContactRafael Linhares
Backup ContactIsmar Cavalcanti
Outcome results
None listed