The Safety and Efficacy of Epidural Oxycodone

Pain, Postoperative Clinical Trial

— epioksipanu  

Official title:

The Safety and Efficacy of Epidural Oxycodone

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02573909
• Other study ID #: KUH2014-004313-82
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: January 1, 2015
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2023
• Source: Kuopio University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Drug:
• Oxycodone intravenously
Oxycodone intravenously 0,1mg/kg
• Oxycodone epidurally
Oxycodone 0,1 mg epidurally

Locations

Country	Name	City	State
Finland	Kuopio University Hospital	Kuopio	Northern Savo

Sponsors (2)

Lead Sponsor	Collaborator
Kuopio University Hospital	Admescope Ltd

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	amount of rescue medicine	The amount of rescue pain medication given after study drug administration up to four hours	from zero hours up to four hours