Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Impact of the SCN9A Gene Polymorphism on Postoperative Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02496455
Recruitment Status : Completed
First Posted : July 14, 2015
Last Update Posted : November 21, 2017
Sponsor:
Information provided by (Responsible Party):
Tuğba Karaman, Tokat Gaziosmanpasa University

Brief Summary:
The purpose of this study to determine the association between postoperative pain after cesarean section and several single nucleotide polymorphisms in SCN9A sodium channels gene.

Condition or disease Intervention/treatment
Pain, Postoperative Pregnancy Procedure: cesarean section Drug: Opioid Tramadol

Detailed Description:
SCN9A gene encodes an alpha subunit of the voltage-gated sodium channel (Nav1.7) and polymorphisms of this gene are associated with severe pain disorders. The impact of the polymorphisms in SCN9A on postoperative pain and opioid consumption after cesarean section is unclear.

Layout table for study information
Study Type : Observational
Actual Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Impact of the Single Nucleotide Polymorphisms rs6746030,rs7604448, rs10930214, s7595255 in SCN9A Gene on Postoperative Pain and Analgesic Consumption After Cesarean Section
Study Start Date : August 2015
Actual Primary Completion Date : May 2017
Actual Study Completion Date : November 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Tramadol


Intervention Details:
  • Procedure: cesarean section
    Women in 36 to 40 weeks of pregnancy undergoing cesarean section by Pfannenstiel technique
  • Drug: Opioid Tramadol
    Tramadol will be administered via patient controlled analgesia (PCA) pump in the postoperative period
    Other Name: Tramadol (contramal)


Primary Outcome Measures :
  1. Pain [ Time Frame: up to postoperative 24 hours ]
    The pain will be evaluated with the visual analog scale


Secondary Outcome Measures :
  1. Opioid consumption [ Time Frame: Up to postoperative 24 hours ]
    The total amount of the tramadol administered to the patient will be recorded


Biospecimen Retention:   Samples With DNA
Two ml blood will be collected from the peripheral venous before the operation and all blood samples will be stored at -80℃. Genomic DNA will be extracted from the blood samples and polymorphism in SCN9A gene will be identified by PCR


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The women in 36 to 40 weeks of pregnancy undergoing cesarean section will be included
Criteria

Inclusion Criteria:

  • The women aged 18 to 45,
  • in 36 to 40 weeks of pregnancy
  • undergoing cesarean section

Exclusion Criteria:

  • History of chronic pain or pain disorders
  • Psychiatric diseases
  • Diabetes mellitus
  • Severe cardiovascular, kidney or liver diseases
  • Alcohol or drug abuse
  • Heavy smoker
  • Unable to use the Patient controlled analgesia (PCA) pump

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02496455


Locations
Layout table for location information
Turkey
Gaziosmanpasa University Medical School Hospital
Tokat, Turkey, 60100
Sponsors and Collaborators
Tokat Gaziosmanpasa University
Investigators
Layout table for investigator information
Principal Investigator: Tugba Karaman, M.D. Gaziosmanpasa University Medical School
Layout table for additonal information
Responsible Party: Tuğba Karaman, Assistant Professor, M.D., Tokat Gaziosmanpasa University
ClinicalTrials.gov Identifier: NCT02496455    
Other Study ID Numbers: GEN-S
First Posted: July 14, 2015    Key Record Dates
Last Update Posted: November 21, 2017
Last Verified: August 2017
Keywords provided by Tuğba Karaman, Tokat Gaziosmanpasa University:
NAV1.7 Voltage-Gated Sodium Channel
pain, postoperative
cesarean section
Additional relevant MeSH terms:
Layout table for MeSH terms
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Tramadol
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents