Hip Fractures
Conditions
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.
Interventions
DRUGLevobupivacaine
Local anaesthetic drug belonging to the amino amide group. It is the S-enantiomer of bupivacaine
DRUGRopivacaine
Local anaesthetic drug belonging to the amino amide group. The name ropivacaine refers to both the racemate and the marketed S-enantiomer.
Sponsors
Instituto de Investigación Biomédica de Salamanca
Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Low-intervention clinical trial
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the Analgesic Efficacy of Both Local Anesthetics in the Regional Block of Hip Fracture Surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Latency of Initiation. | 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. | 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. |
| Secondary Effects Derived From the Combined Technique Described. | 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. |
| Usefulness of the Chosen Analgesic Scale in Our Population, Especially in Patients With Cognitive Impairment. | 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. 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 |
Countries
Spain
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 56 |
| 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. | 52 |
| Total | 108 |
Baseline characteristics
| Characteristic | LEVOBUPIVACAINE | ROPIVACAINE | Total |
|---|---|---|---|
| Age, Continuous | 86.40 years STANDARD_DEVIATION 7.56 | 86.13 years STANDARD_DEVIATION 8.47 | 86.27 years STANDARD_DEVIATION 7.99 |
| Patients Treated | 56 Participants | 52 Participants | 108 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment Spain | 56 participants | 52 participants | 108 participants |
| Sex: Female, Male Female | 41 Participants | 43 Participants | 84 Participants |
| Sex: Female, Male Male | 15 Participants | 9 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 56 | 0 / 52 |
| other Total, other adverse events | 0 / 56 | 0 / 52 |
| serious Total, serious adverse events | 0 / 56 | 0 / 52 |
Outcome results
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.
Time frame: 6h, 12h, 24h and 48h
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| LEVOBUPIVACAINE | Evaluation of the Analgesic Efficacy of Both Local Anesthetics in the Regional Block of Hip Fracture Surgery | 12h | 12 Participants |
| LEVOBUPIVACAINE | Evaluation of the Analgesic Efficacy of Both Local Anesthetics in the Regional Block of Hip Fracture Surgery | 48h | 10 Participants |
| LEVOBUPIVACAINE | Evaluation of the Analgesic Efficacy of Both Local Anesthetics in the Regional Block of Hip Fracture Surgery | 24h | 21 Participants |
| LEVOBUPIVACAINE | Evaluation of the Analgesic Efficacy of Both Local Anesthetics in the Regional Block of Hip Fracture Surgery | No rescue | 3 Participants |
| LEVOBUPIVACAINE | Evaluation of the Analgesic Efficacy of Both Local Anesthetics in the Regional Block of Hip Fracture Surgery | 6h | 10 Participants |
| ROPIVACAINE | Evaluation of the Analgesic Efficacy of Both Local Anesthetics in the Regional Block of Hip Fracture Surgery | No rescue | 3 Participants |
| ROPIVACAINE | Evaluation of the Analgesic Efficacy of Both Local Anesthetics in the Regional Block of Hip Fracture Surgery | 6h | 4 Participants |
| ROPIVACAINE | Evaluation of the Analgesic Efficacy of Both Local Anesthetics in the Regional Block of Hip Fracture Surgery | 12h | 14 Participants |
| ROPIVACAINE | Evaluation of the Analgesic Efficacy of Both Local Anesthetics in the Regional Block of Hip Fracture Surgery | 24h | 17 Participants |
| ROPIVACAINE | Evaluation of the Analgesic Efficacy of Both Local Anesthetics in the Regional Block of Hip Fracture Surgery | 48h | 14 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.
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.
Population: EVN, ALGOPLUS and PAINAD pain rating scales in patients treated with Levobupivacaine or Ropivacaine
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LEVOBUPIVACAINE | Latency of Initiation. | 24h | 4.33 score on a scale | Standard Deviation 2.79 |
| LEVOBUPIVACAINE | Latency of Initiation. | 12h | 2.50 score on a scale | Standard Deviation 2.26 |
| LEVOBUPIVACAINE | Latency of Initiation. | 48h | 4.72 score on a scale | Standard Deviation 2.66 |
| LEVOBUPIVACAINE | Latency of Initiation. | 6h | 1.92 score on a scale | Standard Deviation 1.04 |
| ROPIVACAINE | Latency of Initiation. | 48h | 4.58 score on a scale | Standard Deviation 2.84 |
| ROPIVACAINE | Latency of Initiation. | 24h | 3.5 score on a scale | Standard Deviation 2.82 |
| ROPIVACAINE | Latency of Initiation. | 6h | 1.68 score on a scale | Standard Deviation 2.56 |
| ROPIVACAINE | Latency of Initiation. | 12h | 2.91 score on a scale | Standard Deviation 3.15 |
| ALGOPLUS Scale - LEVOBUPIVACAINE | Latency of Initiation. | 48h | 2.32 score on a scale | Standard Deviation 1.27 |
| ALGOPLUS Scale - LEVOBUPIVACAINE | Latency of Initiation. | 6h | 0.94 score on a scale | Standard Deviation 1.25 |
| ALGOPLUS Scale - LEVOBUPIVACAINE | Latency of Initiation. | 12h | 1.3 score on a scale | Standard Deviation 1.06 |
| ALGOPLUS Scale - LEVOBUPIVACAINE | Latency of Initiation. | 24h | 2.16 score on a scale | Standard Deviation 1.37 |
| ALGOPLUS Scale - ROPIVACAINE | Latency of Initiation. | 24h | 1.70 score on a scale | Standard Deviation 1.28 |
| ALGOPLUS Scale - ROPIVACAINE | Latency of Initiation. | 6h | 0.75 score on a scale | Standard Deviation 1.04 |
| ALGOPLUS Scale - ROPIVACAINE | Latency of Initiation. | 12h | 1.38 score on a scale | Standard Deviation 1.43 |
| ALGOPLUS Scale - ROPIVACAINE | Latency of Initiation. | 48h | 2.21 score on a scale | Standard Deviation 1.33 |
| PAINAD Scale - LEVOBUPIVACAINE | Latency of Initiation. | 12h | 1.95 score on a scale | Standard Deviation 1.69 |
| PAINAD Scale - LEVOBUPIVACAINE | Latency of Initiation. | 24h | 3.22 score on a scale | Standard Deviation 1.99 |
| PAINAD Scale - LEVOBUPIVACAINE | Latency of Initiation. | 48h | 3.75 score on a scale | Standard Deviation 2.33 |
| PAINAD Scale - LEVOBUPIVACAINE | Latency of Initiation. | 6h | 1.46 score on a scale | Standard Deviation 2.05 |
| PAINAD Scale - ROPIVACAINE | Latency of Initiation. | 12h | 1.84 score on a scale | Standard Deviation 1.99 |
| PAINAD Scale - ROPIVACAINE | Latency of Initiation. | 48h | 3.36 score on a scale | Standard Deviation 2.14 |
| PAINAD Scale - ROPIVACAINE | Latency of Initiation. | 6h | 1.04 score on a scale | Standard Deviation 1.67 |
| PAINAD Scale - ROPIVACAINE | Latency of Initiation. | 24h | 2.76 score on a scale | Standard Deviation 2.17 |
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.
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
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
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.