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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Huazhong University of Science and Technology
Sponsor:
Information provided by (Responsible Party):
Xianwei Zhang, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier:
NCT01950078
First received: September 23, 2013
Last updated: NA
Last verified: September 2013
History: No changes posted
  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). The visual analog scale (VAS) was used for pain evaluation at rest and move after the operation. And the PCA press frequency and 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). Then genotyping was carried out by direct sequencing.


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

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

Primary Outcome Measures:
  • Preoperative Pressure Pain Threshold (PPT) [ Time Frame: 30 minutes before the operation ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Preoperative Pressure Pain Tolerance (PTO) [ Time Frame: 30 minutes before the operation ] [ Designated as safety issue: Yes ]

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.


Estimated Enrollment: 1500
Study Start Date: August 2013
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: August 2015 (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

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

anticipative 500 healthy volunteers and 1000 surgical patients

Criteria

Inclusion Criteria:

  • •Aged 20-70 years

    • Receiving elective upper abdominal 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
    • Refused PCA administration
    • Disagree to participate to the research
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01950078

Contacts
Contact: Zhang Xianwei, MD 86-13037154560 ourpain@163.com

Locations
China, Hubei
Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology Recruiting
Wuhan, Hubei, China, 430030
Contact: Zhang Caie, MD       zhangcaie1972@126.com   
Principal Investigator: Duan Guangyou, MD         
Sponsors and Collaborators
Xianwei Zhang
Investigators
Study Director: Zhang Xianwei, MD Huazhong University of Science and Technology
  More Information

No publications provided

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
Study First Received: September 23, 2013
Last Updated: September 23, 2013
Health Authority: China: Food and Drug Administration

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

ClinicalTrials.gov processed this record on July 29, 2014