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

Primary Purpose

Hip Fractures

Status
Unknown status
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Levobupivacaine
Ropivacaine
Sponsored by
Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Fractures

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Complejo Asistencial Universitario de SalamancaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

LEVOBUPIVACAINE

ROPIVACAINE

Arm Description

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

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
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.
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.
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

Full Information

First Posted
February 15, 2021
Last Updated
March 2, 2021
Sponsor
Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León
Collaborators
Instituto de Investigación Biomédica de Salamanca
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1. Study Identification

Unique Protocol Identification Number
NCT04773301
Brief Title
Comparative Study Between Levobupivacaine and Ropivacaine in the Hip Fractures of the Elderly
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 13, 2021 (Actual)
Primary Completion Date
September 2021 (Anticipated)
Study Completion Date
October 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León
Collaborators
Instituto de Investigación Biomédica de Salamanca

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fractures

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
108 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
LEVOBUPIVACAINE
Arm Type
Experimental
Arm Description
Patients treated with Levobupivacaine Altan 7.5 mg / ml solution for injection and infusion
Arm Title
ROPIVACAINE
Arm Type
Experimental
Arm Description
Patients treated with Ropivacaine Altan 2 mg / ml solution for infusion
Intervention Type
Drug
Intervention Name(s)
Levobupivacaine
Intervention Description
Local anaesthetic drug belonging to the amino amide group. It is the S-enantiomer of bupivacaine
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Intervention Description
Local anaesthetic drug belonging to the amino amide group. The name ropivacaine refers to both the racemate and the marketed S-enantiomer.
Primary Outcome Measure Information:
Title
To compare the analgesic efficacy of both local anesthetics in the regional block of hip fracture surgery
Description
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).
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.
Secondary Outcome Measure Information:
Title
To describe the behavior of this combined technique in hip fractures, establishing the latency of initiation.
Description
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.
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.
Title
To describe the behavior of this combined technique in hip fractures, establishing the duration of analgesia.
Description
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.
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.
Title
To describe the secondary effects derived from the combined technique described.
Description
Number of participants with treatment-related adverse events as assessed by CTCAE version 5.0 will be used to report toxicity and adverse events.
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.
Title
To validate in our population, especially in patients with cognitive impairment, the usefulness of the chosen analgesic scales.
Description
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
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ricardo López Pérez, PhD
Phone
+34923291100
Ext
55779
Email
ricardo.lopez@scren.es
First Name & Middle Initial & Last Name or Official Title & Degree
Carmen Arias, PhD
Phone
+34923210960
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Agustín Díaz Álvarez, MD PhD
Organizational Affiliation
University of Salamanca
Official's Role
Principal Investigator
Facility Information:
Facility Name
Complejo Asistencial Universitario de Salamanca
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Agustín Díaz Álvarez, MD, PhD
Email
adiazal@saludcastillayleon.es
First Name & Middle Initial & Last Name & Degree
José L González Rodríguez, MD, PhD
Email
jlgonzalezr@saludcastillayleon.es

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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