A comparison of the severity of acute pain and the frequency of chronic pain after post-operative analgesia of lower and higher intensity following surgical emptying of the axillary gland in breast cancer patients in relation to the pharmacogenomics in the metabolism of tramadol – a prospective, double blind, randomised clinical trial

• Conditions: Acute pain after surgical emptying of the axillary gland in breast cancer patients.; MedDRA version: 18.0Level: PTClassification code 10033371Term: PainSystem Organ Class: 10018065 - General disorders and administration site conditions; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2015-000992-28-SI
• Lead Sponsor: Krka, d.d., Novo mesto

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06-10
• Last Update Posted: 4 August 2015

Recruitment & Eligibility

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

Inclusion Criteria

- Surgical emptying of the axillary gland in breast cancer patients.
- Age of the patients between 18 and 70 years.
- Signed on the voluntary consent of the patient.
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 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

- the simultaneous reconstruction of the breast tissue extender or free lobe;
- hypersensitivity to the drug used in the study (a local anesthetic, piritramide, tramadol, naproxen, acetaminophen, pantoprazole);
- the male gender;
- pregnancy;
- a high risk because of anesthesia (ASA above 3);
- under the age of 18 years and above 70;
- liver and kidney disease;
- participants taking drugs that may have affect on the outcome of treatment (other analgesics, drugs for the treatment of central nervous system);
- the presence of a psychiatric disease (dementia, schizophrenia, manic-depressive illness).

Study & Design

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