- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01950078
The Possible Correlations Between the Genes Related to Pain Sensation and the Pain Sensitivity in the General Population
February 12, 2015 updated by: Xianwei Zhang
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.
Study Overview
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 Type
Observational
Enrollment (Actual)
1533
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Hubei
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Wuhan, Hubei, China, 430030
- Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
anticipative 500 healthy volunteers and 1000 surgical patients
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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surgical patients
grouped by receiving surgery
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Healthy volunteers group
grouped by healthy college students
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Preoperative Pressure Pain Threshold (PPT)
Time Frame: 30 minutes before the operation
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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.
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30 minutes before the operation
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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30 minutes before the operation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Zhang Xianwei, MD, Huazhong University of Science and Technology
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2013
Primary Completion (Actual)
August 1, 2014
Study Completion (Actual)
December 1, 2014
Study Registration Dates
First Submitted
September 23, 2013
First Submitted That Met QC Criteria
September 23, 2013
First Posted (Estimate)
September 25, 2013
Study Record Updates
Last Update Posted (Estimate)
February 23, 2015
Last Update Submitted That Met QC Criteria
February 12, 2015
Last Verified
February 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Gene and Pain
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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