Phase 4 N=114 Randomized Treatment

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

Hip Fractures

Bottom Line

View on ClinicalTrials.gov: NCT04773301 ↗

Enrolled (actual)

114

Serious AEs

0.0%

Results posted

Jul 2024

Primary outcome: Primary: Evaluation of the Analgesic Efficacy of Both Local Anesthetics in the Regional Block of Hip Fracture Surgery — 10; 4; 12; 14 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Levobupivacaine (Drug); Ropivacaine (Drug)
Age: Older Adult · 65+ yrs
Sex: All
Sponsor: Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León
Primary completion: Nov 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Evaluation of the Analgesic Efficacy of Both Local Anesthetics in the Regional Block of Hip Fracture Surgery	10; 4; 12; 14; 21; 17	—
SECONDARY Latency of Initiation.	1.92; 1.68; 0.94; 0.75; 1.46; 1.04	—
SECONDARY Secondary Effects Derived From the Combined Technique Described.	—	—
SECONDARY Usefulness of the Chosen Analgesic Scale in Our Population, Especially in Patients With Cognitive Impairment.	—	—

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 .

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04773301). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.