Acute pain after surgical emptying of the axillary gland in breast cancer patients. MedDRA version: 18.0 Level: PT Classification code 10033371 Term: Pain System Organ Class: 10018065 - General disorders and administration site conditions
Conditions
Sponsors
Krka, d.d., Novo mesto
Eligibility
Sex/Gender
All
Inclusion criteria
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
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of the trial is the effectiveness of postoperative analgesia of two different doses (with double-blind procedure) of potent combination of tramadol and paracetamol in acute pain intensity. ;Secondary Objective: - to determine if the expression of genes for the metabolism of tramadol affect on the effectiveness of the treatment of acute pain and on frequency of adverse reactions during the trial - to compare the performance of postoperative analgesia of two different doses of potent combination of tramadol and paracetamol to prevent the development of chronic pain.;Primary end point(s): The primary end point of the trial is to determine the effectiveness of postoperative analgesia of two different doses (with double-blind procedure) of potent combination of tramadol and paracetamol in acute pain intensity.;Timepoint(s) of evaluation of this end point: after 28 days of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary end points of the trial are: - to determine if the expression of genes for the metabolism of tramadol have affect on the effectiveness of the treatment of acute pain and on frequency of side effects during the tria;l - to compare the performance of postoperative analgesia of two different doses of potent combination of tramadol and paracetamol to prevent the development of chronic pain.;Timepoint(s) of evaluation of this end point: after 28 days of treatment and after 1 year after inclusion into the trial. | — |
Countries
Slovenia
Contacts
Public ContactClinical Trials Information
Krka, d.d., Novo mesto
Outcome results
None listed