- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02496455
The Impact of the SCN9A Gene Polymorphism on Postoperative Pain
November 20, 2017 updated by: Tuğba Karaman, Tokat Gaziosmanpasa University
The Impact of the Single Nucleotide Polymorphisms rs6746030,rs7604448, rs10930214, s7595255 in SCN9A Gene on Postoperative Pain and Analgesic Consumption After Cesarean Section
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Actual)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Tokat, Turkey, 60100
- Gaziosmanpasa University Medical School Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
The women in 36 to 40 weeks of pregnancy undergoing cesarean section will be included
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain
Time Frame: up to postoperative 24 hours
|
The pain will be evaluated with the visual analog scale
|
up to postoperative 24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Opioid consumption
Time Frame: Up to postoperative 24 hours
|
The total amount of the tramadol administered to the patient will be recorded
|
Up to postoperative 24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2015
Primary Completion (Actual)
May 1, 2017
Study Completion (Actual)
November 1, 2017
Study Registration Dates
First Submitted
July 9, 2015
First Submitted That Met QC Criteria
July 13, 2015
First Posted (Estimate)
July 14, 2015
Study Record Updates
Last Update Posted (Actual)
November 21, 2017
Last Update Submitted That Met QC Criteria
November 20, 2017
Last Verified
August 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GEN-S
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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