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

• 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: Xianwei Zhang
• Information provided by (Responsible Party): Xianwei Zhang, Huazhong University of Science and Technology

Study Description

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 Design

• 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

Groups and Cohorts

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

Outcome Measures

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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older 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

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
• Other Study ID Numbers: Gene and Pain
• First Posted: September 25, 2013
• 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

Additional relevant MeSH terms:

Hypersensitivity; Immune System Diseases