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

NCT04773301 | Completed Phase 4 Results

• 2 other identifiers: PENG-CAD2020-004697-21
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

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 .

Conditions

Hip Fractures

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• 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.

• 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.

• 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.

Study Arms (2)

LEVOBUPIVACAINE

EXPERIMENTAL

Patients treated with Levobupivacaine Altan 7.5 mg / ml solution for injection and infusion

Drug: Levobupivacaine

ROPIVACAINE

EXPERIMENTAL

Patients treated with Ropivacaine Altan 2 mg / ml solution for infusion

Drug: Ropivacaine

Interventions

Levobupivacaine DRUG

Local anaesthetic drug belonging to the amino amide group. It is the S-enantiomer of bupivacaine

Also known as: Levobupivacaína Altan 7,5 mg/ml solución inyectable y para perfusión E F G

LEVOBUPIVACAINE

Ropivacaine DRUG

Local anaesthetic drug belonging to the amino amide group. The name ropivacaine refers to both the racemate and the marketed S-enantiomer.

Also known as: Ropivacaína Altan 2 mg/ml solución para perfusión EFG

ROPIVACAINE

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• Rejection of the technique.
• Allergy to any of the drugs.
• Coagulation disorders.
• Local infections instead of puncture.
• Vascular prostheses at the femoral level.

Sponsors & Collaborators

• Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León: lead
• Instituto de Investigación Biomédica de Salamanca: collaborator

Study Sites (1)

Complejo Asistencial Universitario de Salamanca

Salamanca, 37007, Spain

Location

Related Publications (1)

• 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.

  PMID: 38337464 RESULT

MeSH Terms

Conditions

Hip Fractures

Interventions

Levobupivacaine; Ropivacaine

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Bupivacaine; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Limitations and Caveats

The age of the patients often makes it difficult for researchers to interpret pain scales.

Results Point of Contact

• Title: Dr. Agustín Díaz Álvarez
• Organization: Complejo Asistencial Universitario de Salamanca - Instituto de Investigación Biomédica de Salamanca (IBSAL)

adiazal@saludcastillayleon.es

0034 923291353

Study Officials

• Agustín Díaz Álvarez, MD PhD

  University of Salamanca

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Low-intervention clinical trial

Study Record Dates

• First Submitted: February 15, 2021
• First Posted: February 26, 2021
• Study Start: February 13, 2021
• Primary Completion: November 26, 2021
• Study Completion: December 1, 2021
• Last Updated: July 19, 2024
• Results First Posted: July 19, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)