Post operative pain control in patients who have undergone major breast surgery for underlying breast cancer. Major breast surgery constitutes
Conditions
Interventions
Trade Name: Oxynorm 10mg/ml solution for injection or infusion
Product Name: Oxycodone
Pharmaceutical Form: Intravenous infusion
Trade Name: Morphine s
Sponsors
The Royal Marsden NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects must be over the age of 18 years Subjects must be undergoing breast surgery and require postoperative infusion of strong opioid postoperatively Subjects must be willing to undergo genetic testing Subjects must be able to give informed consent Subjects must be Caucasian (due to analysis of genetic polymorphisms of allelic frequencies with known ethnic variation of so as to increase the power of the study) 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects must not have a known allergy to morphine or oxycodone
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To examine the doses of morphine and oxycodone required to achieve adequate analgesia when prescribed intravenously via PCA in the setting of postoperative pain in breast cancer patients.; Secondary Objective: To investigate the effect of parenteral oxycodone in the treatment of acute pain. To identify biochemical, immunological, metabolic and genetic factors which predict response and non-response to morphine and oxycodone ; Primary end point(s): The dose of opioid required to achieve adequate analgesia in each 24h period. Secondary end points include: Correlation of primary and secondary endpoints with biochemical, immunological, metabolic and genetic factors. | — |
Countries
United Kingdom
Outcome results
None listed