Clinical trial NCT03815565: Continuous Femoral Block With Levobupivacaine 0.125% or Ropivacaine 0.2% in Elderly Patients With Femoral Fractures
Official title: Comparison Between Continuous Femoral Block With Levobupivacaine 0.125% and Ropivacaine 0.2% for Preoperative Analgesia, in Patients Over 70 Years Old, With Proximal Femoral Fractures: a Randomized, Double-blind Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Femur Fracture
Hip Fractures
Keywords: analgesia
continuous
femoral block
Lead sponsor: Hospital Municipal Miguel Couto
Sponsor class: OTHER
First posted: 2019-01-24
Enrollment: 70
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: intensity of individual pain episodes
timeFrame: 6 hours after hospital admission
Secondary outcomes:
measure: Number of PCA firing
timeFrame: 72 hours
measure: Degree of satisfaction with analgesic therapy
timeFrame: up to 72 hours - at the moment of surgery; or at the end of 72 hours
measure: Quality of sleep
timeFrame: up to 72 hours
measure: the cost of analgesic therapy
timeFrame: up to 72 hours
measure: adverse event
timeFrame: up to 72 hours
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Rafael M Linhares
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.