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This is a multicenter, prospective, randomized, placebo-controlled, double-blind, two-parallel groups study comparing lidocaine (experimental group) to placebo (control group). The study protocol was elaborated using the recommendations of the Consolidated Standards of Reporting Trials (CONSORT) Statement.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| lidocaine | Active Comparator | Lidocaine. Initial dose IV will be 5 mg/kg per day during the first 24 hours the 8 mg/kg per day |
|
| placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Analgesic efficacy | Analgesic efficacy will be assessed from several endpoints. The primary endpoint will be defined as the change of pain level between baseline (T0) and 40 minutes (T1) after baseline. The pain level will be assessed using a self-administered numeric pain intensity scale (NPIS), ranged from 0 (no pain) to 10 (worst pain possible). A minimal 30% decrease of pain level between baseline and T1 will define the success, and other cases will define the failure of the treatment. | 40 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| intensity of the pain neuropathic | the intensity of the pain neuropathic component using the Neuropathic Pain Symptom Inventory (NPSI) at T4, T5, and T6 {Bouhassira, 2004 #9}; the NPSI is a 12-item self-administered questionnaire describing the intensity of the symptoms associated with pain neuropathic | 120 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| raw values of pain levels (NPIS) | raw values of pain levels (NPIS) at each evaluation time, percentage of reduction between the initial level of pain and other evaluation times | 40 minutes |
| tolerance to the treatments |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sebastien SALAS, MD | Contact | +33491384408 | sebastien.salas@ap-hm.fr |
| Name | Affiliation | Role |
|---|---|---|
| Sebastien SALAS, MD | - Service d'Oncologie Médicale et de Soins Palliatifs Assistance Publique Hopitaux de Marseille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| - Service d'Oncologie Médicale et de Soins Palliatifs Assistance Publique Hopitaux de Marseille | Recruiting | Marseille | 13005 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25112302 | Derived | Salas S, Auquier P, Duffaud F, Garnier SR, Deschamps M, Honore S, Sudour P, Baumstarck K. Efficacy of lidocaine in patients receiving palliative care with opioid-refractory cancer pain with a neuropathic component: study protocol for a randomized controlled study. Trials. 2014 Aug 12;15:318. doi: 10.1186/1745-6215-15-318. |
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| Placebo | Drug |
|
The tolerance to the treatment (lidocaine) will be assessed during the first 48 hours following the treatment administration. Adverse events will be cautiously collected (intensity and discomfort): i) lidocaine: arrhythmia, blurred vision, headache, malaise, tremors, metallic taste, nausea/vomiting, perioral numbness and tingling, sedation, and tinnitus.
| 48 hours |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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