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
• 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
• 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

Related Conditions & MeSH terms

• Pain, Postoperative
• Pregnancy

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