Women who are scheduled for breast cancer surgery.
Conditions
Interventions
Trade Name: Oxanest 10 mg/ml inj
Pharmaceutical Form: Injection
CAS Number: 124-90-3
Other descriptive name: OXYCODONE HYDROCHLORIDE
Sponsors
Helsinki University Central Hospital
Eligibility
Inclusion criteria
Inclusion criteria: Women, aged 18-75 years, who have breast cancer and who are scheduled to have breast resection or mastectomy with or without axillary clearance and who sign an informed consent form. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients who have known metastases (other than axillary lymph nodes), who have clinically relevant kidney or liver failure or who are allergic to oxycodone.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess plasma concentrations of oxycodone and its main metabolites that provide satisfactory pain relief after breast cancer surgery. ;Secondary Objective: To assess how much oxycodone is needed during the first 20 postoperative hours for pain relief after breast cancer surgery.;Primary end point(s): Satisfactory pain relief.;Timepoint(s) of evaluation of this end point: Patients will be administered oxycodone 0.05 mg/kg intravenously if needed every 5 minutes until satisfactory pain relief is achieved. At this point pain intensity is assessed with visual analogue scale (VAS) and blood is drawn for future assessment of plasma oxycodone & metabolite concentrations. Aftr this pain intenisty is assessed every 5 minutes until 15 minutes and thereafter every 15 minutes until th patient requested a further dose of analgesic. At this point pain is measured with VAS and blood is drawn after which oxycodone is adminsitered. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Total amount of oxycodone consumed in the postanaesthesia care unit and thereafter on the ward via a PCA (patient controlled analgesia) device during 20 hours from surgery.;Timepoint(s) of evaluation of this end point: 20 hours after surgery. | — |
Countries
Finland
Contacts
Public ContactPain Clinic
Helsinki University Central Hospital
Outcome results
None listed