Clinical trial NCT04773301: Comparative Study Between Levobupivacaine and Ropivacaine in the Hip Fractures of the Elderly
Official title: Randomized and Controlled Phase IV Clinical Trial on the Analgesic Effectiveness of the Combined Blockade in the Hip Fractures of the Elderly: Comparative Study Between Levobupivacaine and Ropivacaine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hip Fractures
Lead sponsor: Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León
Sponsor class: OTHER
Collaborators: name: Instituto de Investigación Biomédica de Salamanca
First posted: 2021-02-26
Enrollment: 114
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Low-intervention clinical trial
Primary purpose: TREATMENT

Brief summary: Prospective, low-level, non-commercial intervention, comparative clinical trial (phase IV) of balanced, randomized groups, to compare the analgesic efficacy of the local anesthetics Ropivacaine and Levobupivacaine in peripheral nerve block in hip fracture surgery in the elderly .

Detailed description: There are several studies that try to identify the ideal anesthetic for the management and control of pain in hip fracture surgery in the elderly. The optimum would be to use an anesthetic with the lowest possible latency, since this will favor the start of surgery. And, at the same time, with a more lasting analgesia with the least motor impairment. Therefore, it is essential to collect data on efficacy (effective block that allows us to mobilize the patient), latency, and analgesic scales appropriate to the cognitive state of the study sample.

Eligibility criteria: Inclusion Criteria:

* The patient will have to voluntarily sign and understand the informed consent that will be provided in writing.
* Patients over 65 years of age, with a hip fracture, who are going to be operated on at the Salamanca University Assistance Complex (CAUSA).

Exclusion Criteria:

* Rejection of the technique.
* Allergy to any of the drugs.
* Coagulation disorders.
* Local infections instead of puncture.
* Vascular prostheses at the femoral level.

Primary outcomes:
measure: Evaluation of the Analgesic Efficacy of Both Local Anesthetics in the Regional Block of Hip Fracture Surgery
timeFrame: 6h, 12h, 24h and 48h
Secondary outcomes:
measure: Latency of Initiation.
timeFrame: The duration of treatment for each patient will be considered until the evaluation of the analgesic scale corresponding to 48 hours after the procedure is performed.
measure: Secondary Effects Derived From the Combined Technique Described.
timeFrame: The duration of treatment for each patient will be considered until the evaluation of the analgesic scale corresponding to 48 hours after the procedure is performed.
measure: Usefulness of the Chosen Analgesic Scale in Our Population, Especially in Patients With Cognitive Impairment.
timeFrame: The duration of treatment for each patient will be considered until the evaluation of the analgesic scale corresponding to 48 hours after the procedure is performed.
Other outcomes:
Locations:
city: Salamanca
country: Spain
facility: Complejo Asistencial Universitario de Salamanca
Study officials:
affiliation: University of Salamanca
name: Agustín Díaz Álvarez, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Salgado-Garcia D, Diaz-Alvarez A, Gonzalez-Rodriguez JL, Lopez-Iglesias MR, Sanchez-Lopez E, Sanchez-Ledesma MJ, Martinez-Trufero MI. Comparison of the Analgesic Efficacy between Levobupivacaine 0.25% and Ropivacaine 0.375% for PENG (Pericapsular Nerve Group) Block in the Context of Hip Fracture Surgery of Elderly Patients: A Single-Center, Randomized, and Controlled Clinical Trial. J Clin Med. 2024 Jan 29;13(3):770. doi: 10.3390/jcm13030770.