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Clinical Trials/EUCTR2015-000992-28-SI
EUCTR2015-000992-28-SI
Active, not recruiting
Not Applicable

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

Krka, d.d., Novo mesto0 sitesJune 10, 2015
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DrugsDoreta

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
Krka, d.d., Novo mesto
Status
Active, not recruiting
Last Updated
10 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
June 10, 2015
End Date
TBD
Last Updated
10 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
Female

Investigators

Eligibility 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

  • •\- 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).

Outcomes

Primary Outcomes

Not specified

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