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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Xianwei Zhang, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier:
NCT01507493
First received: January 2, 2012
Last updated: August 31, 2014
Last verified: August 2014
  Purpose

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.


Condition
Pain
Surgery

Study Type: Observational
Official Title: The Impact of SCN9A Gene Polymorphism on Individual Pain Perception in the General Population

Resource links provided by NLM:


Further study details as provided by Huazhong University of Science and Technology:

Primary Outcome Measures:
  • Opioid Consumption Dose 48h After Operation. [ Time Frame: 48 hours after the operation ] [ Designated as safety issue: Yes ]
  • PCA Press Frequency 48h After Operation. [ Time Frame: 48 hours after the operation ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The Visual Analog Scale 48h After Operation. [ Time Frame: 48 hours after the operation ] [ Designated as safety issue: Yes ]
    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 Threshold (PPT) [ Time Frame: 12 hours before the operation ] [ Designated as safety issue: Yes ]
    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.

  • Preoperative Pressure Pain Tolerance (PTO) [ Time Frame: 12 hours before the operation ] [ Designated as safety issue: Yes ]
    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.


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.


Enrollment: 200
Study Start Date: January 2011
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
mutant alleles
grouped by SCN9A mutant alleles including 3312T, 1719R, 1150W.
wild-type alleles
grouped by SCN9A wild-type alleles including 3312G, 1719C, 1150R.

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.

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

800 Chinese patients receiving elective upper abdominal surgery under general anesthesia

Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01507493

Locations
China, Hubei
Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430030
Sponsors and Collaborators
Xianwei Zhang
Investigators
Study Director: Zhang Xianwei, Doctor Huazhong University of Science and Technology
  More Information

No publications provided

Responsible Party: Xianwei Zhang, Clinical Professor, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier: NCT01507493     History of Changes
Other Study ID Numbers: SCN9A
Study First Received: January 2, 2012
Results First Received: May 30, 2013
Last Updated: August 31, 2014
Health Authority: China: Food and Drug Administration

Keywords provided by Huazhong University of Science and Technology:
gene polymorphism
SCN9A
pain perception
postoperative pain

ClinicalTrials.gov processed this record on October 01, 2014