Hip FracturesPhase 4NCT04773301
Comparative Study Between Levobupivacaine and Ropivacaine in the Hip Fractures of the Elderly
A Phase 4 study testing Levobupivacaine and Ropivacaine in people with Hip Fractures, run by Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León at 1 site in Spain.
Trial 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 . Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hip Fractures
- What is being tested?
- Levobupivacaine and Ropivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteSpain
- Study dates
- 13 Feb 2021to 1 Dec 2021
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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).
Who cannot join
- Rejection of the technique.
- Allergy to any of the drugs.
- Coagulation disorders.
- Local infections instead of puncture.
- Vascular prostheses at the femoral level.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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 .
Read the 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.
- Conditions
- Hip Fractures
- Being tested
- Levobupivacaine, Ropivacaine
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevobupivacaineDrug
Also called Levobupivacaína Altan 7,5 mg/ml solución inyectable y para perfusión E F G
Local anaesthetic drug belonging to the amino amide group. It is the S-enantiomer of bupivacaine
RopivacaineDrug
Also called Ropivacaína Altan 2 mg/ml solución para perfusión EFG
Local anaesthetic drug belonging to the amino amide group. The name ropivacaine refers to both the racemate and the marketed S-enantiomer.
| Study group | Role | What they receive |
|---|---|---|
| LEVOBUPIVACAINE | Experimental | Patients treated with Levobupivacaine Altan 7.5 mg / ml solution for injection and infusion Receives: Drug: Levobupivacaine |
| ROPIVACAINE | Experimental | Patients treated with Ropivacaine Altan 2 mg / ml solution for infusion Receives: Drug: Ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6h, 12h, 24h and 48h
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2021
- Study start13 Feb 2021
- Primary completion26 Nov 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hip FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Low-intervention clinical trial
- Masking
- None (open label)
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Investigación Biomédica de Salamanca
- Responsible party
- Sponsor
- Investigators
- Agustín Díaz Álvarez, MD PhD, Principal investigator, University of Salamanca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04773301
- Sponsor's protocol ID
- PENG-CAD
- Other IDs
- 2020-004697-21
- Status last verified
- Jul 2024
- First submitted
- 15 Feb 2021
- Last updated
- 19 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 38337464
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04773301
- Acronym / sponsor ID
- PENG-CAD
- Conditions
- Hip Fractures
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y LeónUniversity, hospital or other
- Collaborators
- Instituto de Investigación Biomédica de Salamanca
- Study start
- 13 Feb 2021 (actual)
- Primary completion
- 26 Nov 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 26 Feb 2021 (actual)
- Results
- Posted 19 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Low-intervention clinical trial
| Arm | Type | Receives |
|---|---|---|
| LEVOBUPIVACAINE | Experimental | Drug: LevobupivacainePatients treated with Levobupivacaine Altan 7.5 mg / ml solution for injection and infusion |
| ROPIVACAINE | Experimental | Drug: RopivacainePatients treated with Ropivacaine Altan 2 mg / ml solution for infusion |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (5 listed)
- Rejection of the technique.
- Allergy to any of the drugs.
- Coagulation disorders.
- Local infections instead of puncture.
- Vascular prostheses at the femoral level.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LevobupivacaineAlso: Levobupivacaína Altan 7,5 mg/ml solución inyectable y para perfusión E F GLocal anaesthetic drug belonging to the amino amide group. It is the S-enantiomer of bupivacaine | Drug | LEVOBUPIVACAINE |
| RopivacaineAlso: Ropivacaína Altan 2 mg/ml solución para perfusión EFGLocal anaesthetic drug belonging to the amino amide group. The name ropivacaine refers to both the racemate and the marketed S-enantiomer. | Drug | ROPIVACAINE |
Primary outcome
Evaluation of the Analgesic Efficacy of Both Local Anesthetics in the Regional Block of Hip Fracture Surgery
Time frame: 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.
3 secondary outcomes
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.
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.
Usefulness of the Chosen Analgesic Scale in Our Population, Especially in Patients With Cognitive Impairment.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 38337464Salgado-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Agustín Díaz Álvarez, MD PhD principal investigator
University of Salamanca
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Levobupivacaine and Ropivacaine in people with Hip Fractures, run by Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the Analgesic Efficacy of Both Local Anesthetics in the Regional Block of Hip Fracture Surgery (time frame: 6h, 12h, 24h and 48h). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04773301, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2024.