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 (Peng - Pericapsular Nerve Group- and the Femoral Lateral Cutaneous Nerve) 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

Recruiting

Conditions

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 (Anticipated)

108

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Carmen Arias, PhD
  • Phone Number: +34923210960

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

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
Time Frame: 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.

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.
Time Frame: 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.

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.
Time Frame: 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.

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.
Time Frame: 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.
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.
Time Frame: 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. 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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Agustín Díaz Álvarez, MD PhD, University of Salamanca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 13, 2021

Primary Completion (Anticipated)

September 1, 2021

Study Completion (Anticipated)

October 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)

March 3, 2021

Last Update Submitted That Met QC Criteria

March 2, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hip Fractures

Clinical Trials on Levobupivacaine

3
Subscribe