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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| continuous femoral block | Procedure | infusion of anesthetic by PCA pump |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of PCA firing | in each patient at time of evaluation of pain | 72 hours |
| Degree of satisfaction with analgesic therapy | using the 5-point rating scale (very dissatisfied, dissatisfied, neutral, satisfied or very pleased) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rafael Linhares | Contact | +55 21 981436088 | rafaellinhares@me.com | |
| Ismar Cavalcanti | Contact | +55 21 999822993 | ismarcavalcanti@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rafael M Linhares | Recruiting | Rio de Janeiro | 22776050 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27871587 | Background | 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. | |
| 26330019 | Result | 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. |
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after the finish of the study
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| ID | Term |
|---|---|
| D005264 | Femoral Fractures |
| D006620 | Hip Fractures |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D007869 | Leg Injuries |
| D025981 | Hip Injuries |
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randomized
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Only the pharmacist chief knows which participant belongs to each arm
| up to 72 hours - at the moment of surgery; or at the end of 72 hours |
| Quality of sleep | very good, good, bad and very bad | up to 72 hours |
| the cost of analgesic therapy | including catheters, PCA and medication in each patient | up to 72 hours |
| adverse event | paresthesia, nausea, vomiting, ringing in the ear, metallic taste, convulsion or cardiac arrest | up to 72 hours |
| 12791436 | Result | 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. |
| 24764520 | Result | 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. |
| D010468 |
| Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |