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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01507493
• Other study ID #: SCN9A
• Status: Completed
• Phase: N/A
• First received: January 2, 2012
• Last updated: August 31, 2014
• Start date: January 2011
• Est. completion date: December 2012

Study information

• Verified date: August 2014
• Source: Huazhong University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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

N/A

Related Conditions & MeSH terms

• Pain
• Surgery

Locations

Country	Name	City	State
China	Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Xianwei Zhang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Opioid Consumption Dose 48h After Operation.		48 hours after the operation	Yes
Primary	PCA Press Frequency 48h After Operation.		48 hours after the operation	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes