Phase III Clinical Trial, single-center, randomized, double-blind, to demonstrate a lower incidence of acute diaphragmatic paralysis in shoulder surgery following the administration of 25 mg of 0.25% Levobupivacaine to block the brachial lead compared to the administration of 50 mg

Phase 1

• Conditions: Patients who will undergo surgery for arthroscopic shoulder surgery; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2019-003855-12-ES
• Lead Sponsor: Fundación Instituto de Investigación Sanitaria Aragón

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-12-02
• Last Update Posted: 1 February 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 48

Inclusion Criteria

1. Written informed consent to participate in the clinical trial.
2. Be intervened with scheduled arthroscopic shoulder surgery.
3. Age between 18 and 80 years old,
4. ASA I-III.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 8

Exclusion Criteria

1. Allergic to local amide type anesthetics, opioids or nonsteroidal anti-inflammatory drugs.
2. Non-acceptance for the realization of the BBPAI.
3. Contraindication for the realization of the BPBAI,
4. Contraindication for performing a spirometry.
5. History of pulmonary pathology: moderate or severe COPD, or unstable asthma.
6. Previous diaphragmatic paralysis or other neuromuscular pathology with respiratory involvement,
7. Pregnancy
8. Coagulation disorders (INR> 3, TTPA> 35 and AP <50%).
9. Brachial plexus neuropathy.
10. Chronic opioid consumption: defined as the administration of opioids for more than 3 months or equivalent to more than 5 mg daily of VO Morphine for 1 month.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified