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

NCT01507493 | Completed Results DMC

• 1 other identifier: SCN9A
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Surgery

Keywords

gene polymorphism; SCN9A; pain perception; postoperative pain

Outcome Measures

Primary Outcomes (2)

• Opioid Consumption Dose 48h After Operation.

  48 hours after the operation

• PCA Press Frequency 48h After Operation.

  48 hours after the operation

Secondary Outcomes (3)

• The Visual Analog Scale 48h After Operation.

  48 hours after the operation

• Preoperative Pressure Pain Threshold (PPT)

  12 hours before the operation

• Preoperative Pressure Pain Tolerance (PTO)

  12 hours before the operation

Study Arms (2)

mutant alleles

grouped by SCN9A mutant alleles including 3312T, 1719R, 1150W.

wild-type alleles

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

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

800 Chinese patients receiving elective upper abdominal surgery under general anesthesia

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Xianwei Zhang: lead

Study Sites (1)

Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

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.

MeSH Terms

Conditions

Pain; Pain, Postoperative

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Results Point of Contact

• Title: Xianwei Zhang
• Organization: Huazhong University of Science&Technology

znpain@sina.com

13037154560

Study Officials

• Zhang Xianwei, Doctor

  Huazhong University of Science and Technology

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: January 2, 2012
• First Posted: January 11, 2012
• Study Start: January 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: September 3, 2014
• Results First Posted: September 3, 2014

Record last verified: 2014-08

Locations

CN (1)