Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

January 2, 2012
August 31, 2014
January 2011
December 2012   (final data collection date for primary outcome measure)
  • 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 ]
PCA press frequency and drug consumption 48h after operation. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01507493 on ClinicalTrials.gov Archive Site
  • 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.
  • The visual analog scale 48h after operation. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    The visual analog scale (VAS) is used for pain evaluation at rest during patient-controlled analgesia (PCA) treatment 0 h, 12 h,24 h and 48h after operation.
  • Preoperative pressure pain threshold (PPT) and pressure pain tolerance (PTO) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
The Impact of SCN9A Gene Polymorphism on Individual Pain Perception in the General Population
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.

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.

Observational
Not Provided
Not Provided
Retention:   Samples With DNA
Description:

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.

Non-Probability Sample

800 Chinese patients receiving elective upper abdominal surgery under general anesthesia

  • Pain
  • Surgery
Not Provided
  • mutant alleles
    grouped by SCN9A mutant alleles including 3312T, 1719R, 1150W.
  • wild-type alleles
    grouped by SCN9A wild-type alleles including 3312G, 1719C, 1150R.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
December 2012
December 2012   (final data collection date for primary outcome measure)

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
Both
20 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01507493
SCN9A
Yes
Xianwei Zhang, Huazhong University of Science and Technology
Xianwei Zhang
Not Provided
Study Director: Zhang Xianwei, Doctor Huazhong University of Science and Technology
Huazhong University of Science and Technology
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP