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

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.

Study Overview

• Status: Completed
• Conditions: Pain; Surgery

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: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

800 Chinese patients receiving elective upper abdominal surgery under general anesthesia

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Opioid Consumption Dose 48h After Operation.	48 hours after the operation
PCA Press Frequency 48h After Operation.	48 hours after the operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Visual Analog Scale 48h After Operation.	The visual analog scale (VAS) is used for pain evaluation at rest during patient-controlled analgesia (PCA) treatment 48h after operation. And the visual analog scale is from 0 to 10 which 0 represent no pain while 10 represent unbearable pain	48 hours after the operation
Preoperative Pressure Pain Threshold (PPT)	The probe of pressure algometer was positioned perpendicularly to the skin surface of the patient, and the investigator applied continuous pressure at approximately the same rate according to the visual LCD display on the algometer. subjects were asked to say "pain" when they started to feel pain during the stimulation. The value from the LCD was recorded as the pressure pain threshold.	12 hours before the operation
Preoperative Pressure Pain Tolerance (PTO)	The probe of pressure algometer was positioned perpendicularly to the skin surface of the patient, and the investigator applied continuous pressure at approximately the same rate according to the visual LCD display on the algometer. subjects were asked to say "ok" when they started to feel the pain became intolerable during the stimulation. The value from the LCD was recorded as the pressure pain tolerance.	12 hours before the operation

Collaborators and Investigators

• Sponsor: Xianwei Zhang
• Investigators: Study Director: Zhang Xianwei, Doctor, Huazhong University of Science and Technology

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: January 2, 2012
• First Submitted That Met QC Criteria: January 6, 2012
• First Posted (Estimate): January 11, 2012

Study Record Updates

• Last Update Posted (Estimate): September 3, 2014
• Last Update Submitted That Met QC Criteria: August 31, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Keywords: postoperative pain; pain perception; gene polymorphism; SCN9A
• Other Study ID Numbers: SCN9A