PainNCT01750047
A Epidemiological Survey of Preoperative Pain Perception and Postoperative Pain in Chinese Population
An observational study of Pain and Surgery, run by Xianwei Zhang at 1 site in China.
Trial summary
Object: Every person's pain perception and possible postoperative pain is different. As the investigators know, they are affected by many factors. However, the investigators don't know whether the smoking factors, alcohol factors, surgery type, education background, etc. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- How many people
- 1,327 participants
- Where
- 1 siteChina
- Study dates
- Oct 2012to Apr 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Chinese patients receiving elective surgery under general anesthesia
Who may be able to join
- Aged 18 to 70
- The right hand is handedness
- Agreed to participate the research
- Not with known chronic disease
- Not taking analgesics within 3 months
Who cannot join
- History of chronic pain diseases
- Diabetes mellitus
- Severe cardiovascular diseases
- Kidney or liver diseases
- Alcohol or drug abuse
- 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
Object: Every person's pain perception and possible postoperative pain is different. As the investigators know, they are affected by many factors. However, the investigators don't know whether the smoking factors, alcohol factors, surgery type, education background, etc. will affect individual pain perception and possible postoperative pain in Chinese population. This study was conducted to investigate the power of these possible affect factors. Method: 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)and also investigated the patient's personal information of smoking factors, alcohol factors, surgery type, education background, etc. In addition, we retrospectively investigated the visual analog scale (VAS) during patient-controlled analgesia (PCA) treatment 0 to 48 h after operation as well as the PCA press frequency and drug consumption of those patients who received PCA administration.
Read the detailed description
Patients with the following diseases were excluded: known history of chronic pain, psychiatric diseases or communication disorders, diabetes mellitus, severe cardiovascular diseases, kidney or liver diseases with poor hepatic function, alcohol or pregnancy or at the lactation period.
- Keywords
- pain perception, postoperative pain, demography, smoking, alcohol
- Medical subject headings
- Pain, Pain, Postoperative, Smoking
What is being measured
The primary outcome is the main question the study is designed to answer.
Pressure pain threshold
Measured: 1 year
Pressure pain tolerance
Measured: 1 year
Secondary outcomes (2)
Pain scores on visual analog scale after operation
Measured: 1 year
Opioid consumption dose after operation
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2012 (estimated)
- Study startOct 2012
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Cross-sectional
- Enrolment
- 1,327 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, Doctor, Principal investigator, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01750047
- Sponsor's protocol ID
- Pain Epidemiology
- Status last verified
- Sep 2014
- First submitted
- 11 Dec 2012
- Last updated
- 8 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Epidemiological Survey of Preoperative Pain Perception and Postoperative Pain in Chinese Population
- ClinicalTrials.gov ID
- NCT01750047
- Acronym / sponsor ID
- Pain Epidemiology
- Keywords
- pain perception, postoperative pain, demography, smoking, alcohol
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,327 participants (actual)
- Lead sponsor
- Xianwei ZhangUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 17 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Object: Every person's pain perception and possible postoperative pain is different. As the investigators know, they are affected by many factors. However, the investigators don't know whether the smoking factors, alcohol factors, surgery type, education background, etc. will affect individual pain perception and possible postoperative pain in Chinese population. This study was conducted to investigate the power of these possible affect factors. Method: 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)and also investigated the patient's personal information of smoking factors, alcohol factors, surgery type, education background, etc. In addition, we retrospectively investigated the visual analog scale (VAS) during patient-controlled analgesia (PCA) treatment 0 to 48 h after operation as well as the PCA press frequency and drug consumption of those patients who received PCA administration.
Detailed description
Patients with the following diseases were excluded: known history of chronic pain, psychiatric diseases or communication disorders, diabetes mellitus, severe cardiovascular diseases, kidney or liver diseases with poor hepatic function, alcohol or pregnancy or at the lactation period.
Study design
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chinese patients receiving elective surgery under general anesthesia
Key inclusion criteria (5 listed)
- Aged 18 to 70
- The right hand is handedness
- Agreed to participate the research
- Not with known chronic disease
- Not taking analgesics within 3 months
Key exclusion criteria (7 listed)
- History of chronic pain diseases
- Diabetes mellitus
- Severe cardiovascular diseases
- Kidney or liver diseases
- Alcohol or drug abuse
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
Pressure pain threshold
Time frame: 1 year
Pressure pain tolerance
Time frame: 1 year
2 secondary outcomes
Pain scores on visual analog scale after operation
Time frame: 1 year
Opioid consumption dose after operation
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2014.
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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, Doctor principal investigator
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 5 inclusion and 7 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 8 Sep 2014. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pressure pain threshold (time frame: 1 year). The study lists 2 primary outcomes in all. 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 8 Sep 2014.