Pain, Postoperative
Conditions
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.
Interventions
DRUGOxycodone intravenously
Oxycodone intravenously 0,1mg/kg
DRUGOxycodone epidurally
Oxycodone 0,1 mg epidurally
Sponsors
Admescope Ltd
Kuopio University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
similar syringes equal amount of drug
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Planned gynecological lower abdomen surgery with epidural pain treatment * Informed consent obtained
Exclusion criteria
* Planned surgery under regional anesthesia * contraindication to the study drug * contraindication to the lumbar puncture * Contraindication to oxycodone * Pregnancy or lactation * no informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Finland
Outcome results
None listed