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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-004697-21 | EudraCT Number |
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| Name | Class |
|---|---|
| Instituto de Investigación Biomédica de Salamanca | OTHER |
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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 .
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LEVOBUPIVACAINE | Experimental | Patients treated with Levobupivacaine Altan 7.5 mg / ml solution for injection and infusion |
|
| ROPIVACAINE | Experimental | Patients treated with Ropivacaine Altan 2 mg / ml solution for infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levobupivacaine | Drug | Local anaesthetic drug belonging to the amino amide group. It is the S-enantiomer of bupivacaine |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Agustín Díaz Álvarez, MD PhD | University of Salamanca | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Complejo Asistencial Universitario de Salamanca | Salamanca | 37007 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38337464 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | LEVOBUPIVACAINE | Patients treated with Levobupivacaine Altan 7.5 mg / ml solution for injection and infusion Levobupivacaine: Local anaesthetic drug belonging to the amino amide group. It is the S-enantiomer of bupivacaine |
| FG001 | ROPIVACAINE | Patients treated with Ropivacaine Altan 2 mg / ml solution for infusion Ropivacaine: Local anaesthetic drug belonging to the amino amide group. The name ropivacaine refers to both the racemate and the marketed S-enantiomer. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | LEVOBUPIVACAINE | Patients treated with Levobupivacaine Altan 7.5 mg / ml solution for injection and infusion Levobupivacaine: Local anaesthetic drug belonging to the amino amide group. It is the S-enantiomer of bupivacaine |
| BG001 | ROPIVACAINE |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | 6h, 12h, 24h and 48h |
|
At 48 h it is considered the end of follow-up
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | LEVOBUPIVACAINE | Patients treated with Levobupivacaine Altan 7.5 mg / ml solution for injection and infusion Levobupivacaine: Local anaesthetic drug belonging to the amino amide group. It is the S-enantiomer of bupivacaine |
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The age of the patients often makes it difficult for researchers to interpret pain scales.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Agustín Díaz Álvarez | Complejo Asistencial Universitario de Salamanca - Instituto de Investigación Biomédica de Salamanca (IBSAL) | 0034 923291353 | adiazal@saludcastillayleon.es |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 1, 2020 | Apr 6, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 1, 2020 | Apr 6, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D006620 | Hip Fractures |
| ID | Term |
|---|---|
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
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| ID | Term |
|---|---|
| D000077554 | Levobupivacaine |
| D000077212 | Ropivacaine |
| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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Low-intervention clinical trial
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| Ropivacaine | Drug | Local anaesthetic drug belonging to the amino amide group. The name ropivacaine refers to both the racemate and the marketed S-enantiomer. |
|
|
| 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. |
Patients treated with Ropivacaine Altan 2 mg / ml solution for infusion Ropivacaine: Local anaesthetic drug belonging to the amino amide group. The name ropivacaine refers to both the racemate and the marketed S-enantiomer. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Patients Treated | Count of Participants | Participants |
|
|
|
| Secondary | 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. | EVN, ALGOPLUS and PAINAD pain rating scales in patients treated with Levobupivacaine or Ropivacaine | Posted | Mean | Standard Deviation | score on a scale | 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 | 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. | Not Posted | 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. | Participants |
| Secondary | 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 | Not Posted | 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. | Participants |
| 0 |
| 56 |
| 0 |
| 56 |
| 0 |
| 56 |
| EG001 | ROPIVACAINE | Patients treated with Ropivacaine Altan 2 mg / ml solution for infusion Ropivacaine: Local anaesthetic drug belonging to the amino amide group. The name ropivacaine refers to both the racemate and the marketed S-enantiomer. | 0 | 52 | 0 | 52 | 0 | 52 |
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| D007869 |
| Leg Injuries |
| Aniline Compounds |
| D000588 | Amines |
| 12h |
|
| 24h |
|
| 48h |
|