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The Possible Correlations Between the Genes Related to Pain Sensation and the Pain Sensitivity in the General Population

The Possible Correlations Between the Genes Related to Pain Sensation and the Pain Sensitivity in the General Population

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01950078
Enrollment
1533
Registered
2013-09-25
Start date
2013-08-31
Completion date
2014-12-31
Last updated
2015-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Surgery

Keywords

gene polymorphism, pain perception, postoperative pain

Brief summary

Objective: This study was conducted to explore the possible correlation between some gene related to pain sensation and individual basal pain perception and postoperative pain intensity in the general population. Methods: Patients receiving elective surgery under general anesthesia were recruited into this study. The investigators measured their preoperative pressure pain threshold (PPT) and pressure pain tolerance (PTO). Pain intensity at rest and movement after the operation was evaluated . And the PCA drug consumption were recorded. Also there were healthy college students volunteer be recruited into this study. The investigators measured their experimental pain sensitivity including pressure pain threshold (PPT) and pressure pain tolerance (PTO), etc. Then genotyping was carried out.

Detailed description

Subjects with the following diseases were excluded: known history of chronic disease, 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 lactation period .

Interventions

None listed

Sponsors

Xianwei Zhang
Lead SponsorOTHER

Study design

Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* •Aged 18-65 years * Receiving elective gynecological laparoscopic surgery * Anesthesiologists (ASA) physical status I or II * 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 * Disagree to participate to the research

Design outcomes

Primary

MeasureTime frameDescription
Preoperative Pressure Pain Threshold (PPT)30 minutes before the operationThe 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.

Secondary

MeasureTime frameDescription
Preoperative Pressure Pain Tolerance (PTO)30 minutes before the operationThe 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.

Countries

China

Participant flow

Participants by arm

ArmCount
Surgical Patients
grouped by receiving surgery
1,005
Healthy Volunteers Group
grouped by healthy college students
496
Total1,501

Baseline characteristics

CharacteristicSurgical PatientsHealthy Volunteers GroupTotal
Age, Categorical
<=18 years
11 Participants7 Participants18 Participants
Age, Categorical
>=65 years
4 Participants0 Participants4 Participants
Age, Categorical
Between 18 and 65 years
990 Participants489 Participants1479 Participants
Region of Enrollment
China
1005 participants496 participants1501 participants
Sex: Female, Male
Female
1005 Participants309 Participants1314 Participants
Sex: Female, Male
Male
0 Participants187 Participants187 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 1,0050 / 496
serious
Total, serious adverse events
0 / 1,0050 / 496

Outcome results

Primary

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.

Time frame: 30 minutes before the operation

ArmMeasureValue (MEAN)Dispersion
Surgical PatientsPreoperative Pressure Pain Threshold (PPT)2.33 kg/cm2Standard Deviation 0.97
Healthy Volunteers GroupPreoperative Pressure Pain Threshold (PPT)3.24 kg/cm2Standard Deviation 1.25
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.

Time frame: 30 minutes before the operation

ArmMeasureValue (MEAN)Dispersion
Surgical PatientsPreoperative Pressure Pain Tolerance (PTO)4.65 kg/cm2Standard Deviation 1.66
Healthy Volunteers GroupPreoperative Pressure Pain Tolerance (PTO)6.38 kg/cm2Standard Deviation 2.56

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026