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

Completed

• Conditions: Pain; Surgery

• Registration Number: NCT01507493
• Lead Sponsor: Xianwei Zhang

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 Timeline

• Study Start: 2011-01
• Study First Submitted: 2012-01-02
• Study First Submitted QC: 2012-01-06
• Study First Posted: 2012-01-11
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Results First Submitted: 2013-05-30
• Status Verified: 2014-08
• Results First Submitted QC: 2014-08-31
• Last Update Submitted: 2014-08-31
• Results First Posted: 2014-09-03
• Last Update Posted: 2014-09-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
PCA Press Frequency 48h After Operation.	48 hours after the operation
Opioid Consumption Dose 48h After Operation.	48 hours after the operation

Secondary Outcome Measures

Name	Time	Method
Preoperative Pressure Pain Threshold (PPT)	12 hours before the operation	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.
The Visual Analog Scale 48h After Operation.	48 hours after the 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
Preoperative Pressure Pain Tolerance (PTO)	12 hours before the operation	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.

Trial Locations

Locations (1)

Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China