MOR and COMT SNP Polymorphism and Pain

NCT ID: NCT00773760

Last Updated: 2009-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-10-31

Study Completion Date

2009-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Pain Relief

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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dosing

SNP genotyping

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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East Tallinn Central Hospital

OTHER

Sponsor Role lead

Responsible Party

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TTU

Principal Investigators

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Yuri Kolesnikov, MD PhD

Role: STUDY_DIRECTOR

ETCH

Locations

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Yuri Kolesnikov MD PhD

Tallinn, , Estonia

Site Status RECRUITING

Countries

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Estonia

Facility Contacts

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Peeter Ross, MD

Role: primary

372 6973002

Yuri Kolesnikov

Role: backup

372 6973002

Related Links

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http://www.itk.ee

East Tallinn Central Hospital

Other Identifiers

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ITK-1

Identifier Type: -

Identifier Source: org_study_id

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