The Safety and Efficacy of Epidural Oxycodone (epioksipanu)

Kuopio University Hospital

Status and phase: Active, not recruiting; Phase 4

Conditions: Pain, Postoperative

Treatments: Drug: Oxycodone intravenously; Drug: Oxycodone epidurally

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02573909

KUH2014-004313-82

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

100 participants in 2 patient groups

Oxycodone intravenously

Experimental group

Description:

Oxycodone 0,1 mg/kg IV

Treatment:

Drug: Oxycodone epidurally

Oxycodone epidurally

Experimental group

Description:

Oxycodone 0,1 mg/kg epidurally

Treatment:

Drug: Oxycodone intravenously