PainNCT01950078
The Possible Correlations Between the Genes Related to Pain Sensation and the Pain Sensitivity in the General Population
An observational study of Pain and Surgery, run by Xianwei Zhang at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- How many people
- 1,533 participants
- Where
- 1 siteChina
- Study dates
- Aug 2013to Dec 2014
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: anticipative 500 healthy volunteers and 1000 surgical patients
Who may be able to join
- •Aged 18-65 years
- Receiving elective gynecological laparoscopic surgery
- Anesthesiologists (ASA) physical status I or II
- Agreed to participate the research
Who cannot join
- •History of chronic pain
- Psychiatric diseases
- Diabetes mellitus
- Severe cardiovascular diseases
- Kidney or liver diseases
- Alcohol or drug abuse
Show all 9Show fewer
- Heavy smoker
- Pregnancy or at lactation period
- Disagree to participate to the research
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
About this study
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.
Read the 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 .
- Keywords
- gene polymorphism, pain perception, postoperative pain
- Medical subject headings
- Pain, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| surgical patients | grouped by receiving surgery | |
| Healthy volunteers group | grouped by healthy college students |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 minutes before the operation
Secondary outcomes (1)
Preoperative Pressure Pain Tolerance (PTO)
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.
Measured: 30 minutes before the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2013 (estimated)
- Study startAug 2013
- Primary completionAug 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 1,533 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xianwei Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xianwei Zhang, Huazhong University of Science and Technology
- Investigators
- Zhang Xianwei, MD, Study director, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01950078
- Sponsor's protocol ID
- Gene and Pain
- Status last verified
- Feb 2015
- First submitted
- 23 Sep 2013
- Last updated
- 23 Feb 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Possible Correlations Between the Genes Related to Pain Sensation and the Pain Sensitivity in the General Population
- ClinicalTrials.gov ID
- NCT01950078
- Acronym / sponsor ID
- Gene and Pain
- Keywords
- gene polymorphism, pain perception, postoperative pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,533 participants (actual)
- Lead sponsor
- Xianwei ZhangUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 25 Sep 2013 (estimated)
- Results
- Posted 23 Feb 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| surgical patients | – | –grouped by receiving surgery |
| Healthy volunteers group | – | –grouped by healthy college students |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- anticipative 500 healthy volunteers and 1000 surgical patients
Key inclusion criteria (4 listed)
- •Aged 18-65 years
Key exclusion criteria (9 listed)
- •History of chronic pain
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Preoperative Pressure Pain Tolerance (PTO)
Time frame: 30 minutes before the operation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhang Xianwei, MD study director
Huazhong University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain and Surgery, run by Xianwei Zhang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Feb 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preoperative Pressure Pain Threshold (PPT) (time frame: 30 minutes before the operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2015.