Try the modernized beta website. Learn more about the modernization effort.
Working… Menu

OXY-1: The Pharmacogenetics of Oxycodone Analgesia in Postoperative Pain

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. Identifier: NCT00260260
Recruitment Status : Completed
First Posted : December 1, 2005
Last Update Posted : January 11, 2008
Information provided by:
Odense University Hospital

Brief Summary:
Patients undergoing surgery (thyroidectomy and hysterectomy) will postoperatively receive oxycodone intravenously (IV) as pain management with morphine as an escape medicine, if there is insufficient pain relief with oxycodone. Patients' pain and side effects will be registered and after 24 hours they will answer a questionnaire. All included patients will be genotyped accordingly to CYP2D6 and relevant single nucleotide polymorphisms (SNPs), and measures of plasma levels of oxycodone will be performed.

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

Detailed Description:

Oxycodone is a semi-synthetic opioid with an analgesic effect in the postoperative pain management comparable to morphine. Oxycodone is N-demethylated by CYP2D6 to its active metabolite oxymorphone, a potent μ-receptor agonist. A genetic polymorphism divides a Caucasian population into two groups: 8% with an enzyme lacking activity, poor metabolizers (PM) and the rest with normal CYP2D6 activity, extensive metabolizers (EM).

Many different, single nucleotide polymorphisms (SNPs) are responsible for interindividual differences in the effect of opioids. Among these are the A118G SNP in the μ-receptor gene OPRM1 and the C3435T and G2677T/A SNPs in the MDR-1 gene of P-glycoprotein. P-glycoprotein is responsible for the absorption, excretion and transport of many drugs including opioids over the blood-brain barrier.

The patients will receive the first Oxycodone dosis of 5 mg iv at the end of the surgery. If their pain is not sufficiently relieved they can be given maximum two times Oxycodone 5 mg iv in the recovery room. If still not sufficiently pain relieved they will be given escape medication (Morphine 5 mg iv) until sufficient pain relief.

Further pain treatment will be by Patient Controlled Analgesia (PCA) with bolus doses of Oxycodone 2 mg iv.

During the first 24 hours postoperatively the patients pain and side effects will be registered.

Three blood samples will be drawn: 1. approximately 30 minutes after first Oxycodone dosis, 2. before leaving the recovery room a couple of hours after surgery and 3. 24 hours after surgery. From these samples plasma levels of Oxycodone and its metabolites will be determined and the genotype of CYP2D6 and the above mentioned SNPs will be determined.

The patients will be divided into two groups: Responder and Non-responder. The Responders are characterized by no use of escape medication (morphine) and satisfaction with pain management in final questionnaire. The Non-responders are characterized by use of escape medicine and/or dissatisfaction with pain management in final questionnaire.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Pharmacogenetics of Oxycodone Analgesia in Postoperative Pain
Study Start Date : June 2005
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Responder (satisfaction with pain treatment in questionnaire and no escape medication)
  2. Non-responder (dissatisfaction with pain management in questionnaire and/or escape medication)
  3. Responder status compared to CYP2D6 genotype

Secondary Outcome Measures :
  1. Registration of pain, side effects and total amount of oxycodone given compared to CYP2D6 genotype and SNPs

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Ages 18-80 years old
  • Caucasian race
  • Signed informed consent
  • Patients admitted for one of the following operations: thyroidectomy, mastectomy, hysterectomy, mammaexpander operation, nasal septum correction and jaw operations.

Exclusion Criteria:

  • Allergy towards oxycodone
  • Previous daily opioid use
  • Known severe illness (terminal cancer, severe dementia, uncompensated heart failure, kidney failure, liver failure and severe lung failure)
  • Lack of ability to use patient controlled analgesia or to follow the trial protocol
  • Pregnancy
  • Severe psychiatric illness
  • Alcoholism
  • Ongoing treatment with potent CYP2D6 inhibitors (fluoxetine, paroxetine and terbinafine)
  • Severe perioperative complications or re-operation within the first 24 hours
  • Use of extra pain management during the anaesthesia with an effect after the operation

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 identifier (NCT number): NCT00260260

Layout table for location information
Odense University Hospital
Odense C, Odense, Denmark, DK-5000
Sponsors and Collaborators
Odense University Hospital
Layout table for investigator information
Principal Investigator: Stine T. Zwisler, Dr. University of Southern Denmark
Layout table for additonal information Identifier: NCT00260260    
Other Study ID Numbers: EudraCT 2005-001145-42
First Posted: December 1, 2005    Key Record Dates
Last Update Posted: January 11, 2008
Last Verified: January 2008
Additional relevant MeSH terms:
Layout table for MeSH terms
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Neurologic Manifestations
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents