MOR and COMT SNP Polymorphism and Pain

Sponsor

East Tallinn Central Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT00773760

Collaborator

(none)

100

Enrollment

Location

Duration (Months)

7.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Pain Relief	Other: SNP genotyping

Detailed 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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Oct 1, 2008

Anticipated Primary Completion Date :

Oct 1, 2009

Anticipated Study Completion Date :

Dec 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
dosing	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.

Arm

Intervention/Treatment

dosing

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.

Outcome Measures

Primary Outcome Measures

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]

Secondary Outcome Measures

No secondary outcome endpoint [no time frame]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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