Trial Outcomes & Findings for The Impact of SCN9A Gene Polymorphism on Individual Pain Perception in the General Population (NCT NCT01507493)

Results Overview

Recruitment status

COMPLETED

Target enrollment

200 participants

Primary outcome timeframe

48 hours after the operation

Results posted on

2014-09-03

Participant Flow

Participant milestones

Participant milestones
Measure	Mutant Alleles grouped by SCN9A mutant alleles including 3312T, 1719R, 1150W.	Wild-type Alleles grouped by SCN9A wild-type alleles including 3312G, 1719C, 1150R.
Overall Study STARTED	22	178
Overall Study COMPLETED	22	178
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Mutant Alleles n=22 Participants grouped by SCN9A mutant alleles including 3312T, 1719R, 1150W.	Wild-type Alleles n=178 Participants grouped by SCN9A wild-type alleles including 3312G, 1719C, 1150R.	Total n=200 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	22 Participants n=5 Participants	162 Participants n=7 Participants	184 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	16 Participants n=7 Participants	16 Participants n=5 Participants
Age, Continuous	51.9 years STANDARD_DEVIATION 9.3 • n=5 Participants	55.6 years STANDARD_DEVIATION 5.3 • n=7 Participants	55.2 years STANDARD_DEVIATION 5.7 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	101 Participants n=7 Participants	113 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	77 Participants n=7 Participants	87 Participants n=5 Participants
Region of Enrollment China	22 participants n=5 Participants	178 participants n=7 Participants	200 participants n=5 Participants

PRIMARY outcome

Timeframe: 48 hours after the operation

Outcome measures

Outcome measures
Measure	Mutant Alleles n=22 Participants grouped by SCN9A mutant alleles including 3312T, 1719R, 1150W.	Wild-type Alleles n=178 Participants grouped by SCN9A wild-type alleles including 3312G, 1719C, 1150R.
Opioid Consumption Dose 48h After Operation.	37.4 microgramme Standard Deviation 10.4	50.4 microgramme Standard Deviation 20.4

PRIMARY outcome

Timeframe: 48 hours after the operation

Outcome measures

Outcome measures
Measure	Mutant Alleles n=22 Participants grouped by SCN9A mutant alleles including 3312T, 1719R, 1150W.	Wild-type Alleles n=178 Participants grouped by SCN9A wild-type alleles including 3312G, 1719C, 1150R.
PCA Press Frequency 48h After Operation.	8.8 presses per day Standard Deviation 5.6	19.9 presses per day Standard Deviation 12.7

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Mutant Alleles n=22 Participants grouped by SCN9A mutant alleles including 3312T, 1719R, 1150W.	Wild-type Alleles n=178 Participants grouped by SCN9A wild-type alleles including 3312G, 1719C, 1150R.
The Visual Analog Scale 48h After Operation.	6.9 units on a scale Standard Deviation 2.5	5.0 units on a scale Standard Deviation 1.7

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Mutant Alleles n=22 Participants grouped by SCN9A mutant alleles including 3312T, 1719R, 1150W.	Wild-type Alleles n=178 Participants grouped by SCN9A wild-type alleles including 3312G, 1719C, 1150R.
Preoperative Pressure Pain Threshold (PPT)	3.6 kg/cm2 Standard Deviation 1.0	3.7 kg/cm2 Standard Deviation 1.8

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Mutant Alleles n=22 Participants grouped by SCN9A mutant alleles including 3312T, 1719R, 1150W.	Wild-type Alleles n=178 Participants grouped by SCN9A wild-type alleles including 3312G, 1719C, 1150R.
Preoperative Pressure Pain Tolerance (PTO)	6.6 kg/cm2 Standard Deviation 3.6	6.5 kg/cm2 Standard Deviation 2.6

Adverse Events

Mutant Alleles

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Wild-type Alleles

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Xianwei Zhang

Huazhong University of Science&Technology

Phone: 13037154560

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place