Clinical trial NCT01507493: The Impact of SCN9A Gene Polymorphism on Individual Pain Perception in the General Population
Official title: The Impact of SCN9A Gene Polymorphism on Individual Pain Perception in the General Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain
Surgery
Keywords: gene polymorphism
SCN9A
pain perception
postoperative pain
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
First posted: 2012-01-11
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 800 Chinese patients receiving elective upper abdominal surgery under general anesthesia

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* Aged 20-70 years
* Receiving elective upper abdominal surgery
* Anesthesiologists (ASA) physical status I or II
* Received PCA administration
* 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
* Refused PCA administration
* Disagree to participate to the research

Primary outcomes:
measure: Opioid Consumption Dose 48h After Operation.
timeFrame: 48 hours after the operation
measure: PCA Press Frequency 48h After Operation.
timeFrame: 48 hours after the operation
Secondary outcomes:
measure: The Visual Analog Scale 48h After Operation.
timeFrame: 48 hours after the operation
measure: Preoperative Pressure Pain Threshold (PPT)
timeFrame: 12 hours before the operation
measure: Preoperative Pressure Pain Tolerance (PTO)
timeFrame: 12 hours before the operation
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
affiliation: Huazhong University of Science and Technology
name: Zhang Xianwei, Doctor
role: STUDY_DIRECTOR
References: