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MOR and COMT SNP Polymorphism and Pain

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by East Tallinn Central Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
East Tallinn Central Hospital
ClinicalTrials.gov Identifier:
NCT00773760
First received: October 15, 2008
Last updated: August 4, 2009
Last verified: August 2009
History of Changes

October 15, 2008
August 4, 2009
October 2008
October 2009   (final data collection date for primary outcome measure)
Postoperative assessments include PCA use (e.g., number of patient demands, total morphine administered) in each 24-h interval during the 48-h study period - primary endpoint. [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00773760 on ClinicalTrials.gov Archive Site
No secondary outcome endpoint [ Time Frame: no time frame ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
MOR and COMT SNP Polymorphism and Pain
Does mu Opioid Receptor (MOR) and Catechol-O-methyltransferase (COMT) Genes Polymorphism Correlate of Clinical Postoperative Pain and Response to Analgesics

Patients with certain polymorphism in the MOR and COMT genes will display differences in their response to analgesics.

After tissue injury, there is great interindividual variability among patients in the amount of pain experienced (pain intensity and duration of pain) and in the degree of pain relief from analgesics. In experimental settings, Single Nucleotide Polymorphisms (SNP) at the MOR and COMT genes have been found to alter the response to opioids in in vitro models and in human.We will collect clinical data on one hundred patients undergoing surgery. We will obtain DNA extracted via PCR techniques from the patients' blood and we will identify SNPs at the mu opioid receptor and catechol-O-methyltransferase genes. We will analyze the data to search for correlation between clinical patterns of postoperative pain and opioid effects and SNPs.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

blood
Probability Sample

patients with prostate cancer
Pain Relief
Other: SNP genotyping
Coded blood specimens will be transported to the Department of Gene Technology TTÜ and genotyping analysis will be performed. Lymphocytes will be isolated from blood specimens using Ficol-Paq gradients, and genomic DNA isolated using a salting-out procedure. Variants of the MOR gene and other genes of interests will be performed by DNA sequence analysis of PCR-amplified DNA, using primers located in flanking intron sequence. All methods proposed are currently in operation in the respective facilities.
Other Name: SNP genotyping
dosing
Intervention: Other: SNP genotyping
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
December 2009
October 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 18 years of age and older
  • Give informed consent to participate in this study

Exclusion Criteria:

  • Neurologic or psychiatric disease sufficient, in the clinical judgment of the investigator, to compromise informed consent or data collection
  • ASA classification score 3 or above
  • Patients with past or present history of substance abuse.
  • Patients with a history of chronic pain requiring daily analgesic use for more then one month.
  • Patients with a current diagnosis of anxiety or depression requiring medical treatment
  • Patients allergic to morphine
Both
18 Years to 75 Years
No
Not Provided
Estonia
 
NCT00773760
ITK-1
Yes
A.Veske PhD Director of Department of Gene Technology, TTU
East Tallinn Central Hospital
Not Provided
Study Director: Yuri Kolesnikov, MD PhD ETCH
East Tallinn Central Hospital
August 2009

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