Comparative Study Between Levobupivacaine and Ropivacaine in the Hip Fractures of the Elderly
- Registration Number
- NCT04773301
- Lead Sponsor
- Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 114
- 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).
- Rejection of the technique.
- Allergy to any of the drugs.
- Coagulation disorders.
- Local infections instead of puncture.
- Vascular prostheses at the femoral level.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ROPIVACAINE Ropivacaine Patients treated with Ropivacaine Altan 2 mg / ml solution for infusion LEVOBUPIVACAINE Levobupivacaine Patients treated with Levobupivacaine Altan 7.5 mg / ml solution for injection and infusion
- Primary Outcome Measures
Name Time Method Evaluation of the Analgesic Efficacy of Both Local Anesthetics in the Regional Block of Hip Fracture Surgery 6h, 12h, 24h and 48h The primary measure of efficacy in this study will be the difference in block duration. To evaluate this, the need for rescue medication will be assessed at several time points, including 6, 12, 24, and 48 hours.
- Secondary Outcome Measures
Name Time Method Usefulness of the Chosen Analgesic Scale in Our Population, Especially in Patients With Cognitive Impairment. 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. 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. 0=Min - 5=Max Paint Assessment in Advanced Dementia Scale (PAINAD):Breathing (independent of vocalization), Negative vocalization, Facial expression, Body language and Consolability. 0=Min - 5=MaxSecondary Effects Derived From the Combined Technique Described. 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. Number of participants with treatment-related adverse events as assessed by CTCAE version 5.0 will be used to report toxicity and adverse events.
Latency of Initiation. 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. This study aims to describe the behavior of the combined technique in hip fractures by establishing the latency of initiation.
Latency: evaluated by analgesic scales up to 48 hours. Analgesic scales: EVN - numerical verbal scale- (0= No pain (min) - 10=The worst pain imaginable (max)), Algoplus (0=min - 5=max) and PAINAD -Paint Assessment in Advanced Dementia- (0=min - 10=Max). They will be carried out at 6, 12, 24 and 48 h after the procedure blocking. In both scales, the lowest values are those of better outcome and the highest are those of worst outcome.
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.
Trial Locations
- Locations (1)
Complejo Asistencial Universitario de Salamanca
🇪🇸Salamanca, Spain