The Safety and Efficacy of Epidural Oxycodone
- Conditions
- Pain, Postoperative
- Interventions
- Registration Number
- NCT02573909
- Lead Sponsor
- Kuopio University Hospital
- Brief Summary
There are conflicting results in earlier studies concerning the safety and efficacy of epidural oxycodone. In a study by Bäcklund and colleagues, epidural oxycodone was as effective as intravenous oxycodone, so they did not recommend epidural use of oxycodone. In another study, Yanagidate and Dohi reported that oxycodone was as effective in pain treatment with double dose compared to epidural morphine. In our previous study, epidural oxycodone provided safe and effective pain relief when compared to intravenous oxycodone.
In the present study, the aim was to compare the efficacy and safety of epidural or intravenous oxycodone in patients undergoing elective gynecological surgery with planned epidural pain treatment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 100
- Planned gynecological lower abdomen surgery with epidural pain treatment
- Informed consent obtained
- Planned surgery under regional anesthesia
- contraindication to the study drug
- contraindication to the lumbar puncture
- Contraindication to oxycodone
- Pregnancy or lactation
- no informed consent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Oxycodone intravenously Oxycodone epidurally Oxycodone 0,1 mg/kg IV Oxycodone epidurally Oxycodone intravenously Oxycodone 0,1 mg/kg epidurally
- Primary Outcome Measures
Name Time Method amount of rescue medicine from zero hours up to four hours The amount of rescue pain medication given after study drug administration up to four hours
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Kuopio University Hospital
🇫🇮Kuopio, Northern Savo, Finland