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 III Clinical Trial, single-center, randomized, double-blind, to demonstrate a lower incidence of acute diaphragmatic paralysis of the brachial plexus block with interscalene approach in arthroscopic shoulder surgery after administration of 25 mg of 0.25% Levobupivacaine compared to 50 mg administration

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-003855-12-ES

Enrollment

Registered

2019-12-02

Start date

2020-01-07

Completion date

Unknown

Last updated

2020-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients who will undergo surgery for arthroscopic shoulder surgery

Interventions

Trade Name: CHIROCANE 2,5 mg/ml SOLUCION INYECTABLE Y PARA PERFUSION Pharmaceutical Form: Solution for injection/infusion INN or Proposed INN: LEVOBUPIVACAINE HYDROCHLO

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: Demonstrate a lower statistically significant incidence of acute diaphragmatic paralysis diagnosed by ultrasound using the Diaphragmatic Thickness Ratio after Brachial Plexus Block with ultrasound-guided interscholastic approach in scheduled arthroscopic shoulder surgery after administration of a 10 ml volume of Levobupivacaine 0 , 25% (25 mg dose) compared to 20 ml of 0.25% Levobupivacaine (50 mg dose).; Secondary Objective: 1 Demonstrate a lower incidence of acute diaphragmatic paralysis diagnosed by spirometry (FVC, FEV1 and PEF) after Brachial Plexus Blocking with ultrasound-guided interscholastic approach in scheduled arthroscopic shoulder surgery after 10 ml of Levobupivacaine (25 mg dose) compared with 20 ml (dose 50 mg). 2 Demonstrate a lower incidence of acute diaphragmatic paralysis diagnosed by ultrasound (Diaphragmatic excursion according to the number of intercostal spaces) after Brachial Plexus Blocking with ultrasound-guided interscholastic approach in scheduled arthroscopic shoulder surgery after administration of 10 ml of Levobupivacaine in comparison with 20 ml. 3 Demonstrate the non-inferiority of postoperative analgesia after Brachial Plexus Block with ultrasound-guided interscalenic approach in scheduled arthroscopic shoulder surgery after administration of a volume of 10 ml of Levobupivacaine compared to 20 ml. ;Primary end point(s): This study aims to demonstrate that by decreasing the volume (20 ml to 10 ml) and the dose (50 mg to 25 mg) of local anesthetic used in a BPBAI in the usual clinical practice of arthroscopic shoulder surgery, a decreased PDA objectified by ultrasound and spirometry with maintenance of postoperative analgesia; Timepoint(s) of evaluation of this end point: 1 hour post surgical intervention is measured: 1. Inspiratory diaphragmatic thickness. 2. Expiratory diaphragmatic thickness.	—

Measure

Time frame

Main Objective: Demonstrate a lower statistically significant incidence of acute diaphragmatic paralysis diagnosed by ultrasound using the Diaphragmatic Thickness Ratio after Brachial Plexus Block with ultrasound-guided interscholastic approach in scheduled arthroscopic shoulder surgery after administration of a 10 ml volume of Levobupivacaine 0 , 25% (25 mg dose) compared to 20 ml of 0.25% Levobupivacaine (50 mg dose).; Secondary Objective: 1 Demonstrate a lower incidence of acute diaphragmatic paralysis diagnosed by spirometry (FVC, FEV1 and PEF) after Brachial Plexus Blocking with ultrasound-guided interscholastic approach in scheduled arthroscopic shoulder surgery after 10 ml of Levobupivacaine (25 mg dose) compared with 20 ml (dose 50 mg). 2 Demonstrate a lower incidence of acute diaphragmatic paralysis diagnosed by ultrasound (Diaphragmatic excursion according to the number of intercostal spaces) after Brachial Plexus Blocking with ultrasound-guided interscholastic approach in scheduled arthroscopic shoulder surgery after administration of 10 ml of Levobupivacaine in comparison with 20 ml. 3 Demonstrate the non-inferiority of postoperative analgesia after Brachial Plexus Block with ultrasound-guided interscalenic approach in scheduled arthroscopic shoulder surgery after administration of a volume of 10 ml of Levobupivacaine compared to 20 ml. ;Primary end point(s): This study aims to demonstrate that by decreasing the volume (20 ml to 10 ml) and the dose (50 mg to 25 mg) of local anesthetic used in a BPBAI in the usual clinical practice of arthroscopic shoulder surgery, a decreased PDA objectified by ultrasound and spirometry with maintenance of postoperative analgesia; Timepoint(s) of evaluation of this end point: 1 hour post surgical intervention is measured: 1. Inspiratory diaphragmatic thickness. 2. Expiratory diaphragmatic thickness.

—

Secondary

Measure	Time frame
Secondary end point(s): Incidence of acute diaphragmatic paralysis diagnosed by spirometry (FVC, FEV1 and PEF) Incidence of acute diaphragmatic paralysis diagnosed by ultrasound (Diaphragmatic excursion according to the number of intercostal spaces). No inferiority of postoperative analgesia after the Brachial Plexus Block with an ultrasound-guided Interscalene approach. ;Timepoint(s) of evaluation of this end point: 1 hour post surgical intervention	—

Measure

Time frame

Secondary end point(s): Incidence of acute diaphragmatic paralysis diagnosed by spirometry (FVC, FEV1 and PEF) Incidence of acute diaphragmatic paralysis diagnosed by ultrasound (Diaphragmatic excursion according to the number of intercostal spaces). No inferiority of postoperative analgesia after the Brachial Plexus Block with an ultrasound-guided Interscalene approach. ;Timepoint(s) of evaluation of this end point: 1 hour post surgical intervention

—

Countries

Spain

Contacts

Public ContactUnidad de Investigación Clínica

Fundación Instituto de Investigación Sanitaria Aragón

pmillan@iisaragon.es0034976713259

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 23, 2026