Efficacy and safety of epidural oxycodone
- Conditions
- Acute postoperative pain after gynaecologic surgery.Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Registration Number
- EUCTR2014-004313-82-FI
- Lead Sponsor
- Anaesthesia and Operative Services, Kuopio University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- Not specified
Women aged 18–75 yr undergoing elective gynaecological surgery with planned postoperative epidural analgesia. Patients must provide written consent.
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 50
Patient is unwilling to give consent, has allergy/hypersensitivity to oxycodone or other ingredients in the formulations, has reduced respiratory function, has defects in the vertebral column that are likely to hinder the placement of epidural and spinal catheters, is pregnant or nursing, has a tendency for bleeding or is currently on an anticoagulant therapy, or who has used oxycodone during the previous week, or MAO, CYP3A, or CYP2D6 inhibitors during the previous month, cancer surgery.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method