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

NCT01950078 | Completed Results DMC

• 1 other identifier: Gene and Pain
• Study Type: observational
• Target: 1,533
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Surgery

Keywords

gene polymorphism; pain perception; postoperative pain

Outcome Measures

Primary Outcomes (1)

• Preoperative Pressure Pain Threshold (PPT)

  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.

  30 minutes before the operation

Secondary Outcomes (1)

• Preoperative Pressure Pain Tolerance (PTO)

  30 minutes before the operation

Study Arms (2)

surgical patients

grouped by receiving surgery

Healthy volunteers group

grouped by healthy college students

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

anticipative 500 healthy volunteers and 1000 surgical patients

You may qualify if:

• Aged 18-65 years
• Receiving elective gynecological laparoscopic surgery
• Anesthesiologists (ASA) physical status I or II
• Agreed to participate the research

You may not qualify if:

• 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

Sponsors & Collaborators

• Xianwei Zhang: lead

Study Sites (1)

Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

Location

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.

MeSH Terms

Conditions

Pain; Pain, Postoperative

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Results Point of Contact

• Title: Dr. Xianwei Zhang
• Organization: Huazhong University of Science and Technology

znpin@sina.cn

027 83663173

Study Officials

• Zhang Xianwei, MD

  Huazhong University of Science and Technology

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: September 23, 2013
• First Posted: September 25, 2013
• Study Start: August 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: December 1, 2014
• Last Updated: February 23, 2015
• Results First Posted: February 23, 2015

Record last verified: 2015-02

Locations

CN (1)