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NCT02496455 Clinical Trial

The Impact of the SCN9A Gene Polymorphism on Postoperative Pain

Pregnancy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02496455
Other study ID # GEN-S
Secondary ID
Status Completed
Phase N/A
First received July 9, 2015
Last updated November 20, 2017
Start date August 2015
Est. completion date November 2017

Study information
Verified date August 2017
Source Tokat Gaziosmanpasa University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 200
Est. completion date November 2017
Est. primary completion date May 2017
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 45 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Turkey Gaziosmanpasa University Medical School Hospital Tokat

Sponsors (1)
Lead Sponsor Collaborator
Tokat Gaziosmanpasa University

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pain The pain will be evaluated with the visual analog scale up to postoperative 24 hours
Secondary Opioid consumption The total amount of the tramadol administered to the patient will be recorded Up to postoperative 24 hours
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