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The Safety and Efficacy of Epidural Oxycodone (epioksipanu)

Primary Purpose

Pain, Postoperative

Status
Active
Phase
Phase 4
Locations
Finland
Study Type
Interventional
Intervention
Oxycodone intravenously
Oxycodone epidurally
Sponsored by
Kuopio University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Kuopio University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Oxycodone intravenously

Oxycodone epidurally

Arm Description

Oxycodone 0,1 mg/kg IV

Oxycodone 0,1 mg/kg epidurally

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
October 8, 2015
Last Updated
March 14, 2023
Sponsor
Kuopio University Hospital
Collaborators
Admescope Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT02573909
Brief Title
The Safety and Efficacy of Epidural Oxycodone
Acronym
epioksipanu
Official Title
The Safety and Efficacy of Epidural Oxycodone
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 1, 2015 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kuopio University Hospital
Collaborators
Admescope Ltd

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
similar syringes equal amount of drug
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Oxycodone intravenously
Arm Type
Experimental
Arm Description
Oxycodone 0,1 mg/kg IV
Arm Title
Oxycodone epidurally
Arm Type
Experimental
Arm Description
Oxycodone 0,1 mg/kg epidurally
Intervention Type
Drug
Intervention Name(s)
Oxycodone intravenously
Other Intervention Name(s)
oxycodoneIV
Intervention Description
Oxycodone intravenously 0,1mg/kg
Intervention Type
Drug
Intervention Name(s)
Oxycodone epidurally
Other Intervention Name(s)
oxycodoneEpid
Intervention Description
Oxycodone 0,1 mg epidurally
Primary Outcome Measure Information:
Title
amount of rescue medicine
Description
The amount of rescue pain medication given after study drug administration up to four hours
Time Frame
from zero hours up to four hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Merja Kokki, PhD
Organizational Affiliation
Kuopio University Hospital, Kuopio, Finland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kuopio University Hospital
City
Kuopio
State/Province
Northern Savo
ZIP/Postal Code
70029
Country
Finland

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

The Safety and Efficacy of Epidural Oxycodone

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