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

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

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 .

Study Overview

• Status: Completed
• Conditions: Hip Fractures
• Intervention / Treatment: Drug: Levobupivacaine; Drug: Ropivacaine

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.

• Study Type: Interventional
• Enrollment (Actual): 114
• Phase: Phase 4

Contacts and Locations

Study Locations

• Spain
  • Salamanca, Spain, 37007
    • Complejo Asistencial Universitario de Salamanca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LEVOBUPIVACAINE; Patients treated with Levobupivacaine Altan 7.5 mg / ml solution for injection and infusion	Drug: Levobupivacaine; Local anaesthetic drug belonging to the amino amide group. It is the S-enantiomer of bupivacaine; Other Names: Levobupivacaína Altan 7,5 mg/ml solución inyectable y para perfusión E F G
Experimental: ROPIVACAINE; Patients treated with Ropivacaine Altan 2 mg / ml solution for infusion	Drug: Ropivacaine; Local anaesthetic drug belonging to the amino amide group. The name ropivacaine refers to both the racemate and the marketed S-enantiomer.; Other Names: Ropivacaína Altan 2 mg/ml solución para perfusión EFG

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the Analgesic Efficacy of Both Local Anesthetics in the Regional Block of Hip Fracture Surgery	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.	6h, 12h, 24h and 48h

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Latency of Initiation.	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.	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 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.
Usefulness of the Chosen Analgesic Scale in Our Population, Especially in Patients With Cognitive Impairment.	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=Max	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.

Collaborators and Investigators

• Sponsor: Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León
• Collaborators: Instituto de Investigación Biomédica de Salamanca
• Investigators: Principal Investigator: Agustín Díaz Álvarez, MD PhD, University of Salamanca

Publications and helpful links

General Publications

• 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.

Helpful Links

• Trial results

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2021
• Primary Completion (Actual): November 26, 2021
• Study Completion (Actual): December 1, 2021

Study Registration Dates

• First Submitted: February 15, 2021
• First Submitted That Met QC Criteria: February 24, 2021
• First Posted (Actual): February 26, 2021

Study Record Updates

• Last Update Posted (Actual): July 19, 2024
• Last Update Submitted That Met QC Criteria: July 18, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Fractures, Bone; Hip Fractures; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine; Levobupivacaine
• Other Study ID Numbers: PENG-CAD; 2020-004697-21 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No