- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04773301
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Ricardo López Pérez, PhD
- Phone Number: 55779 +34923291100
- Email: ricardo.lopez@scren.es
Study Contact Backup
- Name: Carmen Arias, PhD
- Phone Number: +34923210960
Study Locations
-
-
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Salamanca, Spain, 37007
- Recruiting
- Complejo Asistencial Universitario de Salamanca
-
Contact:
- Agustín Díaz Álvarez, MD, PhD
- Email: adiazal@saludcastillayleon.es
-
Contact:
- José L González Rodríguez, MD, PhD
- Email: jlgonzalezr@saludcastillayleon.es
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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)
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
Collaborators
Investigators
- Principal Investigator: Agustín Díaz Álvarez, MD PhD, University of Salamanca
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PENG-CAD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
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