Comparative Study Between Levobupivacaine and Ropivacaine in the Hip Fractures of the Elderly

Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León

Status and phase: Completed; Phase 4

Conditions: Hip Fractures

Treatments: Drug: Ropivacaine; Drug: Levobupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT04773301

2020-004697-21 (EudraCT Number)

PENG-CAD

Details and patient eligibility

About

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 .

Full 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.

Enrollment: 114 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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114 participants in 2 patient groups

LEVOBUPIVACAINE

Experimental group

Description:

Patients treated with Levobupivacaine Altan 7.5 mg / ml solution for injection and infusion

Treatment:

Drug: Levobupivacaine

ROPIVACAINE

Experimental group

Description:

Patients treated with Ropivacaine Altan 2 mg / ml solution for infusion

Treatment:

Drug: Ropivacaine