MOR and COMT SNP Polymorphism and Pain

Pain Relief Clinical Trial

Official title:

Does mu Opioid Receptor (MOR) and Catechol-O-methyltransferase (COMT) Genes Polymorphism Correlate of Clinical Postoperative Pain and Response to Analgesics

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00773760
• Other study ID #: ITK-1
• Status: Recruiting
• Phase: N/A
• First received: October 15, 2008
• Last updated: August 4, 2009
• Start date: October 2008
• Est. completion date: December 2009

Study information

• Verified date: August 2009
• Source: East Tallinn Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Estonia: National Institute for Health Development
• Study type: Observational

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pain Relief

Intervention

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.

Locations

Country	Name	City	State
Estonia	Yuri Kolesnikov MD PhD	Tallinn

Sponsors (1)

Lead Sponsor	Collaborator
East Tallinn Central Hospital

Country where clinical trial is conducted

Estonia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		48 hours	No
Secondary	No secondary outcome endpoint		no time frame	No

External Links

•   East Tallinn Central Hospital