The Impact of SCN9A Gene Polymorphism on Individual Pain Perception in the General Population

This study is enrolling participants by invitation only.

Sponsor:

Information provided by (Responsible Party):

Zhang Xianwei, Huazhong University of Science and Technology

ClinicalTrials.gov Identifier:

NCT01507493

First received: January 2, 2012

Last updated: May 31, 2012

Last verified: January 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

January 2, 2012

Last Updated Date

May 31, 2012

Start Date ^ICMJE

January 2011

Estimated Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

PCA press frequency and opioid consumption dose 48h after operation. [ Time Frame: 2 year ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

PCA press frequency and drug consumption 48h after operation. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Change History

Complete list of historical versions of study NCT01507493 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

The visual analog scale 48h after operation. [ Time Frame: 2 year ] [ Designated as safety issue: Yes ]
The visual analog scale (VAS) is used for pain evaluation at rest during patient-controlled analgesia (PCA) treatment 0 h, 12 h,24 h and 48h after operation.
Preoperative pressure pain threshold (PPT) and pressure pain tolerance (PTO) [ Time Frame: 2 year ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

The visual analog scale 48h after operation. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
The visual analog scale (VAS) is used for pain evaluation at rest during patient-controlled analgesia (PCA) treatment 0 h, 12 h,24 h and 48h after operation.
Preoperative pressure pain threshold (PPT) and pressure pain tolerance (PTO) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

The Impact of SCN9A Gene Polymorphism on Individual Pain Perception in the General Population

Official Title ^ICMJE

The Impact of SCN9A Gene Polymorphism on Individual Pain Perception in the General Population

Brief Summary

This study was conducted to explore whether the non-synonymous single-nucleotide polymorphisms in SCN9A gene can predict individual basal pain perception and postoperative pain intensity in the general population undergoing upper abdominal surgery. Methods: Patients receiving elective upper abdominal surgery under general anesthesia were recruited into this study. Genotyping of SCN9A was carried out by direct sequencing. The investigators measured their preoperative pressure pain threshold (PPT) and pressure pain tolerance (PTO). The visual analog scale (VAS) was used for pain evaluation at rest during patient-controlled analgesia (PCA) treatment 0 h, 12 h ,24 h and 48h after operation. And the PCA press frequency and drug consumption were recorded.

Detailed Description

Patients with the following diseases were excluded: known history of chronic pain, psychiatric diseases or communication disorders, diabetes mellitus, severe cardiovascular diseases, kidney or liver diseases with poor hepatic function, alcohol or drug abuse, heavy smoker, pregnancy or at the lactation period.

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Not Provided

Target Follow-Up Duration

Not Provided

Biospecimen

Retention: Samples With DNA

Description:

Heparin anti-coagulated blood (2 ml) was collected from the central venous during the operation and all blood samples were stored at -80℃. Genomic DNA was extracted from the blood samples using a guanidinium isothiocyanate method.

Sampling Method

Non-Probability Sample

Study Population

800 Chinese patients receiving elective upper abdominal surgery under general anesthesia

Condition ^ICMJE

Pain
Surgery

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

mutant alleles
grouped by SCN9A mutant alleles including 3312T, 1719R, 1150W.
wild-type alleles
grouped by SCN9A wild-type alleles including 3312G, 1719C, 1150R.

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Enrolling by invitation

Estimated Enrollment ^ICMJE

800

Estimated Completion Date

December 2012

Estimated Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Aged 20-70 years
Receiving elective upper abdominal surgery
Anesthesiologists (ASA) physical status I or II
Received PCA administration
Agreed to participate the research

Exclusion Criteria:

History of chronic pain
Psychiatric diseases
Diabetes mellitus
Severe cardiovascular diseases
Kidney or liver diseases
Alcohol or drug abuse
Heavy smoker
Pregnancy or at lactation period
Refused PCA administration
Disagree to participate to the research

Gender

Both

Ages

20 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

China

Administrative Information

NCT Number ^ICMJE

NCT01507493

Other Study ID Numbers ^ICMJE

SCN9A

Has Data Monitoring Committee

Yes

Responsible Party

Zhang Xianwei, Huazhong University of Science and Technology

Study Sponsor ^ICMJE

Zhang Xianwei

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Zhang Xianwei, Doctor

Huazhong University of Science and Technology

Information Provided By

Huazhong University of Science and Technology

Verification Date

January 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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