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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01950078
First Posted: September 25, 2013
Last Update Posted: February 23, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Xianwei Zhang, Huazhong University of Science and Technology
  Purpose
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
Pain Surgery

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: The Possible Correlations Between the Genes Related to Pain Sensation and the Pain Sensitivity in the General Population

Resource links provided by NLM:


Further study details as provided by Xianwei Zhang, Huazhong University of Science and Technology:

Primary Outcome Measures:
  • 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:
  • 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.

Enrollment: 1533
Study Start Date: August 2013
Study Completion Date: December 2014
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
surgical patients
grouped by receiving surgery
Healthy volunteers group
grouped by healthy college students

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 .
  Eligibility

Information from the National Library of Medicine

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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
  Contacts and Locations
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
  More Information

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 Submitted: September 23, 2013
First Posted: September 25, 2013
Results First Submitted: January 30, 2015
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