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TREATMENT OF CHRONIC PAIN BY NEUROMODULATION WITH LOCAL ANESTHETIC (NEURALTHERAPY) IN OPERATED AND / OR IRRADIATED PATIENTS FOR HEAD AND NECK, BREST AND, INTRATHROCIC NEOPLASM - LIDO-CLOR

TREATMENT OF CHRONIC PAIN BY NEUROMODULATION WITH LOCAL ANESTHETIC (NEURALTHERAPY) IN OPERATED AND / OR IRRADIATED PATIENTS FOR HEAD AND NECK, BREST AND, INTRATHROCIC NEOPLASM - LIDO-CLOR

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2008-002085-63-IT
Enrollment
Unknown
Registered
2008-05-05
Start date
2008-05-13
Completion date
Unknown
Last updated
2012-03-19

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

Conditions

CHRONIC PAIN IN OPERATED AND / OR IRRADIATED PATIENTS FOR HEAD AND NECK, BREST AND, INTRATHROCIC NEOPLASM MedDRA version: 9.1 Level: LLT Classification code 10039581 Term: Scar conditions and fibrosis of skin

Interventions

Trade Name: LIDOCAINA CLORIDR*5F 200MG10ML Pharmaceutical Form: Solution for infusion INN or Proposed INN: Lidocaine Concentration unit: mg milligram(s) Concentration type: equal Concentration number:

Sponsors

AZIENDA SANITARIA OSPEDALIERA "S. GIOVANNI BATTISTA DI TORINO"
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.previous surgery or surgery + radiation + chemotherapy, with treatment completed at least 30 days for head-neck, lung and breast cancer; 2. Age ≥ 18; 3. Patients in good general condition without active disease of the main organs (heart, lung, liver, kidney); 4. writing and signed Informed consent obtained before starting protocol procedures . 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. active uncontrolled Infection, including human immunodeficiency virus (HIV); 2. drug abuse; 3. allergic reaction to some component of the treatment; 4. Medical or psychological condition that not allow the patient to complete the study or to understand and sign informed consent.

Design outcomes

Primary

MeasureTime frame
Main Objective: Evaluate the effectiveness of neuromodulation with Lidocaina Cloridrato in the treatment of chronic pain and functional recovery postsurgery of patients treated for head and neck, breast and INTRATHROCIC tumors.;Secondary Objective: 1. Assessment of quality of life 2. Assessment of costs about this type of therapy. 3. Evaluation of toxicity;Primary end point(s): 1. Percentage improvement on the scale VAS pain. 2. Time improvement / remission defined as the time between the date of start of treatment with neuralterapy AL and the first clinical signs subjective and / or objective improvement in pain and function. 3. Improved assessment physiatric parameters.—

Countries

Italy

Outcome results

None listed

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