PainNCT01507493
The Impact of SCN9A Gene Polymorphism on Individual Pain Perception in the General Population
An observational study of Pain and Surgery, run by Xianwei Zhang at 1 site in China.
Trial summary
This study was conducted to explore whether the non-synonymous single-nucleotide polymorphisms in SCN9A gene can predict individual basal pain perception and postoperative pain intensity in the general population undergoing upper abdominal surgery. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Jan 2011to Dec 2012
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 800 Chinese patients receiving elective upper abdominal surgery under general anesthesia
Who may be able to join
- Aged 20-70 years
- Receiving elective upper abdominal surgery
- Anesthesiologists (ASA) physical status I or II
- Received PCA administration
- 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 10Show fewer
- Heavy smoker
- Pregnancy or at lactation period
- Refused PCA administration
- 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
This study was conducted to explore whether the non-synonymous single-nucleotide polymorphisms in SCN9A gene can predict individual basal pain perception and postoperative pain intensity in the general population undergoing upper abdominal surgery. Methods: Patients receiving elective upper abdominal surgery under general anesthesia were recruited into this study. Genotyping of SCN9A was carried out by direct sequencing. The investigators measured their preoperative pressure pain threshold (PPT) and pressure pain tolerance (PTO). The visual analog scale (VAS) was used for pain evaluation at rest during patient-controlled analgesia (PCA) treatment 0 h, 12 h ,24 h and 48h after operation. And the PCA press frequency and drug consumption were recorded.
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 drug abuse, heavy smoker, pregnancy or at the lactation period.
- Keywords
- gene polymorphism, SCN9A, 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 |
|---|---|---|
| mutant alleles | grouped by SCN9A mutant alleles including 3312T, 1719R, 1150W. | |
| wild-type alleles | grouped by SCN9A wild-type alleles including 3312G, 1719C, 1150R. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid Consumption Dose 48h After Operation.
Measured: 48 hours after the operation
PCA Press Frequency 48h After Operation.
Measured: 48 hours after the operation
Secondary outcomes (3)
The Visual Analog Scale 48h After Operation.
The visual analog scale (VAS) is used for pain evaluation at rest during patient-controlled analgesia (PCA) treatment 48h after operation. And the visual analog scale is from 0 to 10 which 0 represent no pain while 10 represent unbearable pain
Measured: 48 hours after the operation
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: 12 hours before the operation
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: 12 hours 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 posted11 Jan 2012 (estimated)
- Study startJan 2011
- Primary completionDec 2012
- Study completionDec 2012
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
- Enrolment
- 200 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, Study director, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01507493
- Sponsor's protocol ID
- SCN9A
- Status last verified
- Aug 2014
- First submitted
- 2 Jan 2012
- Last updated
- 3 Sep 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of SCN9A Gene Polymorphism on Individual Pain Perception in the General Population
- ClinicalTrials.gov ID
- NCT01507493
- Acronym / sponsor ID
- SCN9A
- Keywords
- gene polymorphism, SCN9A, pain perception, postoperative pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Xianwei ZhangUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 11 Jan 2012 (estimated)
- Results
- Posted 3 Sep 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was conducted to explore whether the non-synonymous single-nucleotide polymorphisms in SCN9A gene can predict individual basal pain perception and postoperative pain intensity in the general population undergoing upper abdominal surgery. Methods: Patients receiving elective upper abdominal surgery under general anesthesia were recruited into this study. Genotyping of SCN9A was carried out by direct sequencing. The investigators measured their preoperative pressure pain threshold (PPT) and pressure pain tolerance (PTO). The visual analog scale (VAS) was used for pain evaluation at rest during patient-controlled analgesia (PCA) treatment 0 h, 12 h ,24 h and 48h after operation. And the PCA press frequency and drug consumption were recorded.
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 drug abuse, heavy smoker, pregnancy or at the lactation period.
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mutant alleles | – | –grouped by SCN9A mutant alleles including 3312T, 1719R, 1150W. |
| wild-type alleles | – | –grouped by SCN9A wild-type alleles including 3312G, 1719C, 1150R. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 800 Chinese patients receiving elective upper abdominal surgery under general anesthesia
Key inclusion criteria (5 listed)
- Aged 20-70 years
- Receiving elective upper abdominal surgery
- Anesthesiologists (ASA) physical status I or II
- Received PCA administration
- Agreed to participate the research
Key exclusion criteria (10 listed)
- History of chronic pain
- Psychiatric diseases
- Diabetes mellitus
- Severe cardiovascular diseases
- Kidney or liver diseases
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
Opioid Consumption Dose 48h After Operation.
Time frame: 48 hours after the operation
PCA Press Frequency 48h After Operation.
Time frame: 48 hours after the operation
3 secondary outcomes
The Visual Analog Scale 48h After Operation.
Time frame: 48 hours after the operation
Preoperative Pressure Pain Threshold (PPT)
Time frame: 12 hours before the operation
Preoperative Pressure Pain Tolerance (PTO)
Time frame: 12 hours before the operation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2014.
- 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, Doctor 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 5 inclusion and 10 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 3 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?
Yes. Results are posted in the registry (first posted 3 Sep 2014). 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?
Opioid Consumption Dose 48h After Operation. (time frame: 48 hours after the operation). 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 3 Sep 2014.