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

Study Overview
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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 .

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.

Official Title
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Randomized and Controlled Phase IV Clinical Trial on the Analgesic Effectiveness of the Combined Blockade (Peng - Pericapsular Nerve Group- and the Femoral Lateral Cutaneous Nerve) in the Hip Fractures of the Elderly: Comparative Study Between Levobupivacaine and Ropivacaine

Conditions
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Hip Fractures

Intervention / Treatment
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* Drug: Levobupivacaine
* Drug: Ropivacaine


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LEVOBUPIVACAINE<br>Patients treated with Levobupivacaine Altan 7.5 mg / ml solution for injection and infusion | Drug: Levobupivacaine<br>* Local anaesthetic drug belonging to the amino amide group. It is the S-enantiomer of bupivacaine<br>|
| Experimental: ROPIVACAINE<br>Patients treated with Ropivacaine Altan 2 mg / ml solution for infusion | Drug: Ropivacaine<br>* Local anaesthetic drug belonging to the amino amide group. The name ropivacaine refers to both the racemate and the marketed S-enantiomer.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the analgesic efficacy of both local anesthetics in the regional block of hip fracture surgery | The primary endpoint of study efficacy will be the difference in the duration of the block. To compare the analgesic efficacy, we will use 3 assessment scales: Numerical Visual Scale (EVN), Algoplus Scale (ALGSC), and Paint Assessment in Advanced Dementia Scale (PAINAD). | 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. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To describe the behavior of this combined technique in hip fractures, establishing the latency of initiation. | Latency: evaluated by analgesic scales up to 10 minutes. Analgesic scales: EVN, Algoplus and PAINAD at rest and in activity. They will be carried out on arrival of the patient to the operating room, continuous until 10 minutes after the nerve block, in the sitting position to perform the subarachnoid block, upon discharge from the PACU, and at 6, 12, 24 h after the procedure blocking, and end of effect after blocking. Need and rescue drugs: rescue analgesia will be prescribed for the hospital ward, in case it is necessary. The need, drug and time of administration will be collected regarding the execution of the blockade. | 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. | 
| To describe the behavior of this combined technique in hip fractures, establishing the duration of analgesia. | Latency: evaluated by analgesic scales up to 10 minutes. Analgesic scales: EVN, Algoplus and PAINAD at rest and in activity. They will be carried out on arrival of the patient to the operating room, continuous until 10 minutes after the nerve block, in the sitting position to perform the subarachnoid block, upon discharge from the PACU, and at 6, 12, 24 h after the procedure blocking, and end of effect after blocking. Need and rescue drugs: rescue analgesia will be prescribed for the hospital ward, in case it is necessary. The need, drug and time of administration will be collected regarding the execution of the blockade. | 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. | 
| To describe the secondary effects derived from the combined technique described. | Number of participants with treatment-related adverse events as assessed by CTCAE version 5.0 will be used to report toxicity and adverse events. | 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. | 
| To validate in our population, especially in patients with cognitive impairment, the usefulness of the chosen analgesic scales. | We will use 3 assessment scales: Numerical Visual Scale (EVN): 0=No pain - 5=The worst pain imaginable Algoplus Scale (ALGSC): Face, looks, complaints, body and behavior. Paint Assessment in Advanced Dementia Scale (PAINAD):Breathing (independent of vocalization), Negative vocalization, Facial expression, Body language and Consolability | 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. |