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The Safety and Efficacy of Epidural Oxycodone (epioksipanu)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02573909
Recruitment Status : Unknown
Verified March 2017 by Merja Kokki, Kuopio University Hospital.
Recruitment status was:  Recruiting
First Posted : October 12, 2015
Last Update Posted : April 12, 2017
Sponsor:
Collaborator:
Admescope Ltd
Information provided by (Responsible Party):
Merja Kokki, Kuopio University Hospital

Tracking Information
First Submitted Date  ICMJE October 8, 2015
First Posted Date  ICMJE October 12, 2015
Last Update Posted Date April 12, 2017
Study Start Date  ICMJE January 2015
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 9, 2015)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Safety and Efficacy of Epidural Oxycodone
Official Title  ICMJE The Safety and Efficacy of Epidural Oxycodone
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description:
similar syringes equal amount of drug
Primary Purpose: Treatment
Condition  ICMJE Pain, Postoperative
Intervention  ICMJE
  • Drug: Oxycodone intravenously
    Oxycodone intravenously 0,1mg/kg
    Other Name: oxycodoneIV
  • Drug: Oxycodone epidurally
    Oxycodone 0,1 mg epidurally
    Other Name: oxycodoneEpid
Study Arms  ICMJE
  • Experimental: Oxycodone intravenously
    Oxycodone 0,1 mg/kg IV
    Intervention: Drug: Oxycodone epidurally
  • Experimental: Oxycodone epidurally
    Oxycodone 0,1 mg/kg epidurally
    Intervention: Drug: Oxycodone intravenously
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 9, 2015)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2017
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Finland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02573909
Other Study ID Numbers  ICMJE KUH2014-004313-82
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Merja Kokki, Kuopio University Hospital
Study Sponsor  ICMJE Kuopio University Hospital
Collaborators  ICMJE Admescope Ltd
Investigators  ICMJE
Principal Investigator: Merja Kokki, PhD Kuopio University Hospital, Kuopio, Finland
PRS Account Kuopio University Hospital
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP