Trial Outcomes & Findings for Comparative Study Between Levobupivacaine and Ropivacaine in the Hip Fractures of the Elderly (NCT NCT04773301)
NCT ID: NCT04773301
Last Updated: 2024-07-19
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
114 participants
Primary outcome timeframe
6h, 12h, 24h and 48h
Results posted on
2024-07-19
Participant Flow
Participant milestones
| Measure |
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
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
57
|
57
|
|
Overall Study
COMPLETED
|
56
|
52
|
|
Overall Study
NOT COMPLETED
|
1
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
LEVOBUPIVACAINE
n=56 Participants
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
|
ROPIVACAINE
n=52 Participants
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.
|
Total
n=108 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
86.40 years
STANDARD_DEVIATION 7.56 • n=56 Participants
|
86.13 years
STANDARD_DEVIATION 8.47 • n=52 Participants
|
86.27 years
STANDARD_DEVIATION 7.99 • n=108 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=56 Participants
|
43 Participants
n=52 Participants
|
84 Participants
n=108 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=56 Participants
|
9 Participants
n=52 Participants
|
24 Participants
n=108 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Spain
|
56 participants
n=56 Participants
|
52 participants
n=52 Participants
|
108 participants
n=108 Participants
|
|
Patients Treated
|
56 Participants
n=56 Participants
|
52 Participants
n=52 Participants
|
108 Participants
n=108 Participants
|
PRIMARY outcome
Timeframe: 6h, 12h, 24h and 48hThe 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.
Outcome measures
| Measure |
LEVOBUPIVACAINE
n=56 Participants
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
|
ROPIVACAINE
n=52 Participants
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.
|
ALGOPLUS Scale - 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
Algoplus Scale (ALGSC): Face, looks, complaints, body and behavior. 0=Min - 5=Max
|
ALGOPLUS Scale - 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.
Algoplus Scale (ALGSC): Face, looks, complaints, body and behavior. 0=Min - 5=Max
|
PAINAD Scale - 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
Paint Assessment in Advanced Dementia Scale (PAINAD):Breathing (independent of vocalization), Negative vocalization, Facial expression, Body language and Consolability. 0=Min - 10=Max
|
PAINAD Scale - 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.
Paint Assessment in Advanced Dementia Scale (PAINAD):Breathing (independent of vocalization), Negative vocalization, Facial expression, Body language and Consolability. 0=Min - 10=Max
|
|---|---|---|---|---|---|---|
|
Evaluation of the Analgesic Efficacy of Both Local Anesthetics in the Regional Block of Hip Fracture Surgery
6h
|
10 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
|
Evaluation of the Analgesic Efficacy of Both Local Anesthetics in the Regional Block of Hip Fracture Surgery
12h
|
12 Participants
|
14 Participants
|
—
|
—
|
—
|
—
|
|
Evaluation of the Analgesic Efficacy of Both Local Anesthetics in the Regional Block of Hip Fracture Surgery
24h
|
21 Participants
|
17 Participants
|
—
|
—
|
—
|
—
|
|
Evaluation of the Analgesic Efficacy of Both Local Anesthetics in the Regional Block of Hip Fracture Surgery
48h
|
10 Participants
|
14 Participants
|
—
|
—
|
—
|
—
|
|
Evaluation of the Analgesic Efficacy of Both Local Anesthetics in the Regional Block of Hip Fracture Surgery
No rescue
|
3 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
LEVOBUPIVACAINE
n=56 Participants
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
|
ROPIVACAINE
n=52 Participants
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.
|
ALGOPLUS Scale - LEVOBUPIVACAINE
n=56 Participants
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
Algoplus Scale (ALGSC): Face, looks, complaints, body and behavior. 0=Min - 5=Max
|
ALGOPLUS Scale - ROPIVACAINE
n=52 Participants
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.
Algoplus Scale (ALGSC): Face, looks, complaints, body and behavior. 0=Min - 5=Max
|
PAINAD Scale - LEVOBUPIVACAINE
n=56 Participants
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
Paint Assessment in Advanced Dementia Scale (PAINAD):Breathing (independent of vocalization), Negative vocalization, Facial expression, Body language and Consolability. 0=Min - 10=Max
|
PAINAD Scale - ROPIVACAINE
n=52 Participants
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.
Paint Assessment in Advanced Dementia Scale (PAINAD):Breathing (independent of vocalization), Negative vocalization, Facial expression, Body language and Consolability. 0=Min - 10=Max
|
|---|---|---|---|---|---|---|
|
Latency of Initiation.
6h
|
1.92 score on a scale
Standard Deviation 1.04
|
1.68 score on a scale
Standard Deviation 2.56
|
0.94 score on a scale
Standard Deviation 1.25
|
0.75 score on a scale
Standard Deviation 1.04
|
1.46 score on a scale
Standard Deviation 2.05
|
1.04 score on a scale
Standard Deviation 1.67
|
|
Latency of Initiation.
12h
|
2.50 score on a scale
Standard Deviation 2.26
|
2.91 score on a scale
Standard Deviation 3.15
|
1.3 score on a scale
Standard Deviation 1.06
|
1.38 score on a scale
Standard Deviation 1.43
|
1.95 score on a scale
Standard Deviation 1.69
|
1.84 score on a scale
Standard Deviation 1.99
|
|
Latency of Initiation.
24h
|
4.33 score on a scale
Standard Deviation 2.79
|
3.5 score on a scale
Standard Deviation 2.82
|
2.16 score on a scale
Standard Deviation 1.37
|
1.70 score on a scale
Standard Deviation 1.28
|
3.22 score on a scale
Standard Deviation 1.99
|
2.76 score on a scale
Standard Deviation 2.17
|
|
Latency of Initiation.
48h
|
4.72 score on a scale
Standard Deviation 2.66
|
4.58 score on a scale
Standard Deviation 2.84
|
2.32 score on a scale
Standard Deviation 1.27
|
2.21 score on a scale
Standard Deviation 1.33
|
3.75 score on a scale
Standard Deviation 2.33
|
3.36 score on a scale
Standard Deviation 2.14
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 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
Outcome measures
Outcome data not reported
Adverse Events
LEVOBUPIVACAINE
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
ROPIVACAINE
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Agustín Díaz Álvarez
Complejo Asistencial Universitario de Salamanca - Instituto de Investigación Biomédica de Salamanca (IBSAL)
Phone: 0034 923291353
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place