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Clinical Trials/NCT02573909
NCT02573909Active, not recruitingPhase 4

The Safety and Efficacy of Epidural Oxycodone

Kuopio University Hospital1 site in 1 country100 target enrollmentStarted: January 1, 2015Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Active, not recruiting
Sponsor
Enrollment
100
Locations
1
Primary Endpoint
amount of rescue medicine
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Masking Description

similar syringes equal amount of drug

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
Female
Accepts 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

Arms & Interventions

Oxycodone intravenously

Experimental

Oxycodone 0,1 mg/kg IV

Intervention: Oxycodone epidurally (Drug)

Oxycodone epidurally

Experimental

Oxycodone 0,1 mg/kg epidurally

Intervention: Oxycodone intravenously (Drug)

Outcomes

Primary Outcomes

amount of rescue medicine

Time Frame: from zero hours up to four hours

The amount of rescue pain medication given after study drug administration up to four hours

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Kuopio University Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Merja Kokki

MD, PhD

Kuopio University Hospital

Study Sites (1)

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The Safety and Efficacy of Epidural... | Clinical Trial