The Impact of the SCN9A Gene Polymorphism on Postoperativ... | NCT02496455

Studies
The Impact of the SCN9A Gene Polymorphism on Postoperative Pain

NCT02496455

Sponsor

Tokat Gaziosmanpasa University

Status

Completed

Last Update Posted

Nov 21, 2017Actual

Enrollment

200Actual

Phase

Not provided

Conditions

Pain, Postoperative
Pregnancy

Interventions

cesarean section
Opioid Tramadol

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2015

Primary Completion Date

May 2017Actual

Completion Date

Nov 2017Actual

First Submitted Date

Jul 9, 2015

First Submission Date that Met QC Criteria

Jul 13, 2015

First Posted Date

Jul 14, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 20, 2017

Last Update Posted Date

Nov 21, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Tuğba Karaman, Assistant Professor, M.D., Tokat Gaziosmanpasa UniversityPrincipal Investigator

Lead Sponsor

Tokat Gaziosmanpasa UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

200Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
cesarean section	Procedure	Women in 36 to 40 weeks of pregnancy undergoing cesarean section by Pfannenstiel technique
Opioid Tramadol	Drug	Tramadol will be administered via patient controlled analgesia (PCA) pump in the postoperative period		Tramadol (contramal)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain	The pain will be evaluated with the visual analog scale	up to postoperative 24 hours

Secondary Outcomes

Measure	Description	Time Frame
Opioid consumption	The total amount of the tramadol administered to the patient will be recorded	Up to postoperative 24 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

The women in 36 to 40 weeks of pregnancy undergoing cesarean section will be included

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tugba Karaman, M.D.	Gaziosmanpasa University Medical School	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Gaziosmanpasa University Medical School Hospital		Tokat Province		60100	Turkey (Türkiye)

Condition Browse Module

MeSH Terms

ID	Term
D010149	Pain, Postoperative

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002585	Cesarean Section
D014147	Tramadol

Ancestor Terms

ID	Term
D036861	Delivery, Obstetric
D013513	Obstetric Surgical Procedures
D013514	Surgical Procedures, Operative
D003511	Cyclohexanols

Browse Leaves

Not provided

Browse Branches

Not provided

Description

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