Ignite Creation Date:
2024-05-05 @ 12:11 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00260260
Status:
COMPLETED
Last Update Posted:
2008-01-11
First Post:
2005-11-30
Brief Title:
OXY-1 The Pharmacogenetics of Oxycodone Analgesia in Postoperative Pain
Sponsor:
Odense University Hospital
Organization:
Odense University Hospital
Study Overview
Official Title:
The Pharmacogenetics of Oxycodone Analgesia in Postoperative Pain
Status:
COMPLETED
Status Verified Date:
2008-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 G2677TA 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 andor dissatisfaction with pain management in final questionnaire
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 G2677TA 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 andor dissatisfaction with pain management in final questionnaire
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None