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

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ClinicalTrials.gov Identifier: NCT01950078
Recruitment Status : Completed
First Posted : September 25, 2013
Results First Posted : February 23, 2015
Last Update Posted : February 23, 2015
Sponsor:
Information provided by (Responsible Party):
Xianwei Zhang, Huazhong University of Science and Technology

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.

Condition or disease
Pain Surgery

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 .

Study Type : Observational
Actual Enrollment : 1533 participants
Time Perspective: Prospective
Official Title: The Possible Correlations Between the Genes Related to Pain Sensation and the Pain Sensitivity in the General Population
Study Start Date : August 2013
Actual Primary Completion Date : August 2014
Actual Study Completion Date : December 2014

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U.S. FDA Resources

Group/Cohort
surgical patients
grouped by receiving surgery
Healthy volunteers group
grouped by healthy college students



Primary Outcome Measures :
  1. Preoperative Pressure Pain Threshold (PPT) [ Time Frame: 30 minutes 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.


Secondary Outcome Measures :
  1. Preoperative Pressure Pain Tolerance (PTO) [ Time Frame: 30 minutes 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.


Biospecimen Retention:   Samples With DNA
Heparin anti-coagulated blood (5 ml) was collected from the periphery venous of subjects and all blood samples were stored at -80℃. Genomic DNA was extracted from the blood samples using a guanidinium isothiocyanate method.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
anticipative 500 healthy volunteers and 1000 surgical patients
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01950078


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, MD Huazhong University of Science and Technology

Responsible Party: Xianwei Zhang, Clinical Professor, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier: NCT01950078     History of Changes
Other Study ID Numbers: Gene and Pain
First Posted: September 25, 2013    Key Record Dates
Results First Posted: February 23, 2015
Last Update Posted: February 23, 2015
Last Verified: February 2015

Keywords provided by Xianwei Zhang, Huazhong University of Science and Technology:
gene polymorphism
pain perception
postoperative pain