Antiepileptic drug for the management of acute pain posthoracotomy

Analgesic efficacy of intravenous lacosamide administered perioperatively for thoracic surgery with thoracotomy approach. - LACO15

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-001769-14-ES

Enrollment

Unknown

Registered

2016-09-26

Start date

2017-02-13

Completion date

Unknown

Last updated

2017-02-20

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

Conditions

Acute postoperative pain

Interventions

Trade Name: VIMPAT 10 mg/ml solution for infusion Product Name: LACOSAMIDE Pharmaceutical Form: Solution for infusion in administration system INN or Proposed INN: LACOSAMIDE CAS Number: 175481-36-4 C

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: Evaluate the effectiveness in pain relief at 6 hours after administration of a single dose of 100 mg of intravenous lacosamide given in the immediate preoperative chest surgery with thoracotomy approach compared with placebo.;Secondary Objective: - Evaluate the effectiveness in pain relief within 48 hours after four doses of 100 mg lacosamide intravenous (100 mg every 12 hours) compared to placebo. - Incidence of neuropathic pain at 48 hours after four doses of 100 mg lacosamide intravenous. - Side effects associated with lacosamide during the first 48 hours. - Postoperative opioid consumption in control group compared to placebo group. - Evaluate the intensity of nociceptive and neuropathic pain after discharge the patient in the first review;Primary end point(s): The drug is considered effective when the difference between the average value of the VAS (visual analog scale) at 6 hours of lacosamide treated group and the mean value of the VAS at 6 hours of control group, is at least 50%.;Timepoint(s) of evaluation of this end point: 6 hours after lacosamide administration (+/- 30 minutes).	—

Measure

Time frame

Main Objective: Evaluate the effectiveness in pain relief at 6 hours after administration of a single dose of 100 mg of intravenous lacosamide given in the immediate preoperative chest surgery with thoracotomy approach compared with placebo.;Secondary Objective: - Evaluate the effectiveness in pain relief within 48 hours after four doses of 100 mg lacosamide intravenous (100 mg every 12 hours) compared to placebo. - Incidence of neuropathic pain at 48 hours after four doses of 100 mg lacosamide intravenous. - Side effects associated with lacosamide during the first 48 hours. - Postoperative opioid consumption in control group compared to placebo group. - Evaluate the intensity of nociceptive and neuropathic pain after discharge the patient in the first review;Primary end point(s): The drug is considered effective when the difference between the average value of the VAS (visual analog scale) at 6 hours of lacosamide treated group and the mean value of the VAS at 6 hours of control group, is at least 50%.;Timepoint(s) of evaluation of this end point: 6 hours after lacosamide administration (+/- 30 minutes).

—

Secondary

Measure	Time frame
Secondary end point(s): - The drug is considered effective when the difference between the average value of the VAS at 48 hours of lacosamide treated group and the mean value of the VAS at 48 hours of control group, is at least 50%. - Incidence of onset of neuropathic pain in both groups measured by rating scale Pain Detect and DN4. - Consumption of intravenous morphine administered by PCA (patient controlled analgesia pump) in both groups. - Incidence of adverse effects associated with lacosamide. - insensitive of neurotic (measured by Pain Detect and DN4 scales) and nociceptive pain (measured by VAS scale) in both groups in the first postoperative visit after discharge.;Timepoint(s) of evaluation of this end point: - 48h after first dose of lacosamide. (+/- 120 minutes). - 48 h. (+/- 120 minutes). - 48 h. (+/- 120 minutes). - 48 h.(+/- 120 minutes). - 15 days. (+/- one week).	—

Measure

Time frame

Secondary end point(s): - The drug is considered effective when the difference between the average value of the VAS at 48 hours of lacosamide treated group and the mean value of the VAS at 48 hours of control group, is at least 50%. - Incidence of onset of neuropathic pain in both groups measured by rating scale Pain Detect and DN4. - Consumption of intravenous morphine administered by PCA (patient controlled analgesia pump) in both groups. - Incidence of adverse effects associated with lacosamide. - insensitive of neurotic (measured by Pain Detect and DN4 scales) and nociceptive pain (measured by VAS scale) in both groups in the first postoperative visit after discharge.;Timepoint(s) of evaluation of this end point: - 48h after first dose of lacosamide. (+/- 120 minutes). - 48 h. (+/- 120 minutes). - 48 h. (+/- 120 minutes). - 48 h.(+/- 120 minutes). - 15 days. (+/- one week).

—

Countries

Spain

Contacts

Public ContactServicio de Anestesia y Reanimación

Consorcio Hospital General Universitario de Valencia

artd_hguv@gva.es0034963187554

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026