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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

114 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-13

Study Completion Date

2021-12-01

Brief Summary

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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 .

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Detailed Description

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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.

Conditions

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Hip Fractures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Low-intervention clinical trial

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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LEVOBUPIVACAINE

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

Group Type EXPERIMENTAL

Levobupivacaine

Intervention Type DRUG

Local anaesthetic drug belonging to the amino amide group. It is the S-enantiomer of bupivacaine

ROPIVACAINE

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

Group Type EXPERIMENTAL

Ropivacaine

Intervention Type DRUG

Local anaesthetic drug belonging to the amino amide group. The name ropivacaine refers to both the racemate and the marketed S-enantiomer.

Interventions

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Ropivacaine

Local anaesthetic drug belonging to the amino amide group. The name ropivacaine refers to both the racemate and the marketed S-enantiomer.

Intervention Type DRUG

Levobupivacaine

Local anaesthetic drug belonging to the amino amide group. It is the S-enantiomer of bupivacaine

Intervention Type DRUG

Other Intervention Names

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Levobupivacaína Altan 7,5 mg/ml solución inyectable y para perfusión E F G Ropivacaína Altan 2 mg/ml solución para perfusión EFG

Eligibility Criteria

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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.

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No