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The Safety and Efficacy of Epidural Oxycodone (epioksipanu)

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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

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.


Condition or disease Intervention/treatment Phase
Pain, Postoperative Drug: Oxycodone intravenously Drug: Oxycodone epidurally Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: similar syringes equal amount of drug
Primary Purpose: Treatment
Official Title: The Safety and Efficacy of Epidural Oxycodone
Study Start Date : January 2015
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Oxycodone intravenously
Oxycodone 0,1 mg/kg IV
Drug: Oxycodone epidurally
Oxycodone 0,1 mg epidurally
Other Name: oxycodoneEpid

Experimental: Oxycodone epidurally
Oxycodone 0,1 mg/kg epidurally
Drug: Oxycodone intravenously
Oxycodone intravenously 0,1mg/kg
Other Name: oxycodoneIV




Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02573909


Contacts
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Contact: Merja Kokki, PhD +358405853685 merja.kokki@kuh.fi
Contact: Hannu Kokki, professor +358503790374 hannu.kokki@uef.fi

Locations
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Finland
Kuopio University Hospital Recruiting
Kuopio, Northern savo, Finland, 70029
Contact: Merja Kokki, PhD    +358447174764      
Sponsors and Collaborators
Kuopio University Hospital
Admescope Ltd
Investigators
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Principal Investigator: Merja Kokki, PhD Kuopio University Hospital, Kuopio, Finland

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Responsible Party: Merja Kokki, MD, PhD, Kuopio University Hospital
ClinicalTrials.gov Identifier: NCT02573909     History of Changes
Other Study ID Numbers: KUH2014-004313-82
First Posted: October 12, 2015    Key Record Dates
Last Update Posted: April 12, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Oxycodone
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents