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

This study has been completed.
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: February 12, 2015
Last verified: February 2015
  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 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 ]
    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 ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   18 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 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
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

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

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
Results First Received: January 30, 2015
Last Updated: February 12, 2015
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 May 29, 2015