Antiepileptic drug for the management of acute pain posthoracotomy

Phase 1

• Conditions: Acute postoperative pain; Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]

• Registration Number: EUCTR2015-001769-14-ES
• Lead Sponsor: Javier E. Morales Sarabia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09-26
• Last Update Posted: 20 February 2017

Recruitment & Eligibility

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

Inclusion Criteria

- Patients over 18 years and less than or equal to 75 years.
- Patients undergoing thoracic surgery for non-small cell lung cancer (NSCLC) with curative intent or resection of lung metastases by thoracotomy.
- Patients ASA I-III.
- Signature of informed consent.
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 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

- Patient refusal.
- Other diseases that warrant its non-inclusion according to medical criteria: severe renal disease (stage 3 and 4), liver disease (stages B and C ChildPugh) or psychiatric, heart rhythm disorders, bleeding disorders, pregnancy and lactation.
- Lacosamide allergy, NSAIDs, local anesthetics and / or morphic.
- Alcoholism.
- Drug addiction.
- Concurrent use of opioid analgesics or anti-epileptic type in the immediate preoperative period.
- History of epilepsy or any neurological condition that needs treatment with lacosamide or other antiepileptic drug.
- Functional status ASA> III.
- Inability to understand the pain assessment scales.
- Surgery that does not involve thoracotomy (pure thoracoscopic surgery or VATS).
previous thoracotomy.
- Pathology affecting the chest wall (locally invasive lung cancer, empyema thoracis necessitans, intercostal neural lesions, pathological fractures rib).
- Surgery involving extensive involvement of the parietal pleura (such as pleurodesis, pleurectomy, extrapleural resection of the tumor).
- Closing technique with metallic suture points.

Study & Design

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