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

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ClinicalTrials.gov Identifier: NCT01507493
Recruitment Status : Completed
First Posted : January 11, 2012
Results First Posted : September 3, 2014
Last Update Posted : September 3, 2014
Sponsor:
Information provided by (Responsible Party):
Xianwei Zhang, Huazhong University of Science and Technology

Study Type Observational
Conditions Pain
Surgery
Enrollment 200
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Mutant Alleles Wild-type Alleles
Hide Arm/Group Description grouped by SCN9A mutant alleles including 3312T, 1719R, 1150W. grouped by SCN9A wild-type alleles including 3312G, 1719C, 1150R.
Period Title: Overall Study
Started 22 178
Completed 22 178
Not Completed 0 0
Arm/Group Title Mutant Alleles Wild-type Alleles Total
Hide Arm/Group Description grouped by SCN9A mutant alleles including 3312T, 1719R, 1150W. grouped by SCN9A wild-type alleles including 3312G, 1719C, 1150R. Total of all reporting groups
Overall Number of Baseline Participants 22 178 200
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 178 participants 200 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
22
 100.0%
162
  91.0%
184
  92.0%
>=65 years
0
   0.0%
16
   9.0%
16
   8.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 22 participants 178 participants 200 participants
51.9  (9.3) 55.6  (5.3) 55.2  (5.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 178 participants 200 participants
Female
12
  54.5%
101
  56.7%
113
  56.5%
Male
10
  45.5%
77
  43.3%
87
  43.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
China Number Analyzed 22 participants 178 participants 200 participants
22 178 200
1.Primary Outcome
Title Opioid Consumption Dose 48h After Operation.
Hide Description [Not Specified]
Time Frame 48 hours after the operation
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mutant Alleles Wild-type Alleles
Hide Arm/Group Description:
grouped by SCN9A mutant alleles including 3312T, 1719R, 1150W.
grouped by SCN9A wild-type alleles including 3312G, 1719C, 1150R.
Overall Number of Participants Analyzed 22 178
Mean (Standard Deviation)
Unit of Measure: microgramme
37.4  (10.4) 50.4  (20.4)
2.Primary Outcome
Title PCA Press Frequency 48h After Operation.
Hide Description [Not Specified]
Time Frame 48 hours after the operation
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mutant Alleles Wild-type Alleles
Hide Arm/Group Description:
grouped by SCN9A mutant alleles including 3312T, 1719R, 1150W.
grouped by SCN9A wild-type alleles including 3312G, 1719C, 1150R.
Overall Number of Participants Analyzed 22 178
Mean (Standard Deviation)
Unit of Measure: presses per day
8.8  (5.6) 19.9  (12.7)
3.Secondary Outcome
Title The Visual Analog Scale 48h After Operation.
Hide Description 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
Time Frame 48 hours after the operation
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mutant Alleles Wild-type Alleles
Hide Arm/Group Description:
grouped by SCN9A mutant alleles including 3312T, 1719R, 1150W.
grouped by SCN9A wild-type alleles including 3312G, 1719C, 1150R.
Overall Number of Participants Analyzed 22 178
Mean (Standard Deviation)
Unit of Measure: units on a scale
6.9  (2.5) 5.0  (1.7)
4.Secondary Outcome
Title Preoperative Pressure Pain Threshold (PPT)
Hide Description 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.
Time Frame 12 hours before the operation
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mutant Alleles Wild-type Alleles
Hide Arm/Group Description:
grouped by SCN9A mutant alleles including 3312T, 1719R, 1150W.
grouped by SCN9A wild-type alleles including 3312G, 1719C, 1150R.
Overall Number of Participants Analyzed 22 178
Mean (Standard Deviation)
Unit of Measure: kg/cm2
3.6  (1.0) 3.7  (1.8)
5.Secondary Outcome
Title Preoperative Pressure Pain Tolerance (PTO)
Hide Description 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.
Time Frame 12 hours before the operation
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mutant Alleles Wild-type Alleles
Hide Arm/Group Description:
grouped by SCN9A mutant alleles including 3312T, 1719R, 1150W.
grouped by SCN9A wild-type alleles including 3312G, 1719C, 1150R.
Overall Number of Participants Analyzed 22 178
Mean (Standard Deviation)
Unit of Measure: kg/cm2
6.6  (3.6) 6.5  (2.6)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Mutant Alleles Wild-type Alleles
Hide Arm/Group Description grouped by SCN9A mutant alleles including 3312T, 1719R, 1150W. grouped by SCN9A wild-type alleles including 3312G, 1719C, 1150R.
All-Cause Mortality
Mutant Alleles Wild-type Alleles
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Mutant Alleles Wild-type Alleles
Affected / at Risk (%) Affected / at Risk (%)
Total   0/22 (0.00%)   0/178 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Mutant Alleles Wild-type Alleles
Affected / at Risk (%) Affected / at Risk (%)
Total   0/22 (0.00%)   0/178 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Xianwei Zhang
Organization: Huazhong University of Science&Technology
Phone: 13037154560
Responsible Party: Xianwei Zhang, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier: NCT01507493     History of Changes
Other Study ID Numbers: SCN9A
First Submitted: January 2, 2012
First Posted: January 11, 2012
Results First Submitted: May 30, 2013
Results First Posted: September 3, 2014
Last Update Posted: September 3, 2014