Response to Parenteral Morphine and Oxycodone in Acute Pain. - Acute Pain Study Morphine vs Oxycodone
Phase 1
- Conditions
- Post operative pain control in patients who have undergone major breast surgery for underlying breast cancer. Major breast surgery constitutes•Mastectomy •Axillary clearance +/- wide local excision •Breast reconstruction
- Registration Number
- EUCTR2005-003795-37-GB
- Lead Sponsor
- The Royal Marsden NHS Foundation Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 104
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
Subjects must not have a known allergy to morphine or oxycodone
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.;<br> Secondary Objective: To investigate the effect of parenteral oxycodone in the treatment of acute pain.<br><br> To identify biochemical, immunological, metabolic and genetic factors which predict response and non-response to morphine and oxycodone<br> ;<br> Primary end point(s): The dose of opioid required to achieve adequate analgesia in each 24h period.<br><br> Secondary end points include: Correlation of primary and secondary endpoints with biochemical, immunological, metabolic and genetic factors.<br>
- Secondary Outcome Measures
Name Time Method