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NCT04773301

Comparative Study Between Levobupivacaine and Ropivacaine in the Hip Fractures of the Elderly

Completed Phase 4 Results posted Last updated 19 July 2024
What this trial tests

Phase 4 trial testing Levobupivacaine in Hip Fractures in 114 participants. Completed in 1 December 2021.

Timeline
13 February 2021
Primary endpoint
26 November 2021
1 December 2021

Quick facts

Lead sponsorFundación Instituto de Estudios de Ciencias de la Salud de Castilla y León
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment114
Start date13 February 2021
Primary completion26 November 2021
Estimated completion1 December 2021
Sites1 location across Spain

Drugs / interventions tested

Conditions studied

Sponsor

Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León — full company profile →

Who can join

65 and older, any sex, with Hip Fractures. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Evaluation of the Analgesic Efficacy of Both Local Anesthetics in the Regional Block of Hip Fracture Surgery Primary · 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.

6h
GroupValue95% CI
LEVOBUPIVACAINE10
ROPIVACAINE4
12h
GroupValue95% CI
LEVOBUPIVACAINE12
ROPIVACAINE14
24h
GroupValue95% CI
LEVOBUPIVACAINE21
ROPIVACAINE17
48h
GroupValue95% CI
LEVOBUPIVACAINE10
ROPIVACAINE14
No rescue
GroupValue95% CI
LEVOBUPIVACAINE3
ROPIVACAINE3
Latency of Initiation. Secondary · 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 anal

6h
GroupValue95% CI
EVN Scale - LEVOBUPIVACAINE1.92± 1.04
EVN - Scale ROPIVACAINE1.68± 2.56
ALGOPLUS Scale - LEVOBUPIVACAINE0.94± 1.25
ALGOPLUS Scale - ROPIVACAINE0.75± 1.04
PAINAD Scale - LEVOBUPIVACAINE1.46± 2.05
PAINAD Scale - ROPIVACAINE1.04± 1.67
12h
GroupValue95% CI
EVN Scale - LEVOBUPIVACAINE2.50± 2.26
EVN - Scale ROPIVACAINE2.91± 3.15
ALGOPLUS Scale - LEVOBUPIVACAINE1.3± 1.06
ALGOPLUS Scale - ROPIVACAINE1.38± 1.43
PAINAD Scale - LEVOBUPIVACAINE1.95± 1.69
PAINAD Scale - ROPIVACAINE1.84± 1.99
24h
GroupValue95% CI
EVN Scale - LEVOBUPIVACAINE4.33± 2.79
EVN - Scale ROPIVACAINE3.5± 2.82
ALGOPLUS Scale - LEVOBUPIVACAINE2.16± 1.37
ALGOPLUS Scale - ROPIVACAINE1.70± 1.28
PAINAD Scale - LEVOBUPIVACAINE3.22± 1.99
PAINAD Scale - ROPIVACAINE2.76± 2.17
48h
GroupValue95% CI
EVN Scale - LEVOBUPIVACAINE4.72± 2.66
EVN - Scale ROPIVACAINE4.58± 2.84
ALGOPLUS Scale - LEVOBUPIVACAINE2.32± 1.27
ALGOPLUS Scale - ROPIVACAINE2.21± 1.33
PAINAD Scale - LEVOBUPIVACAINE3.75± 2.33
PAINAD Scale - ROPIVACAINE3.36± 2.14

Sponsor's own description

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 .

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. 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.
    Salgado-García D, Díaz-Álvarez A, González-Rodríguez JL, López-Iglesias MR, et al · · 2024 · cited 3× · PMID 38337464 · DOI 10.3390/jcm13030770
  2. Low-Dose Subarachnoid Anesthesia Combined with PENG and FLCN Blocks Reduces Hypotensive Episodes Without Compromising Anesthetic Depth and Duration in Hip Fracture Surgery: A Retrospective Observational Study.
    Salgado-García D, Díaz-Álvarez A, González-Rodríguez JL, López-Iglesias MR, et al · · 2025 · PMID 41155796 · DOI 10.3390/medicina61101808

Verify or expand the search:

Other trials of Levobupivacaine

Trials testing the same drug.

Other recruiting trials for Hip Fractures

Currently open trials in the same condition.

Other Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León trials

Trials by the same sponsor.

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Data sources for this page

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing