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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mutant alleles | grouped by SCN9A mutant alleles including 3312T, 1719R, 1150W. | ||
| wild-type alleles | grouped by SCN9A wild-type alleles including 3312G, 1719C, 1150R. |
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| Measure | Description | Time Frame |
|---|---|---|
| Opioid Consumption Dose 48h After Operation. | 48 hours after the operation | |
| PCA Press Frequency 48h After Operation. | 48 hours after the operation |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 48 hours after the operation |
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Inclusion Criteria:
Exclusion Criteria:
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800 Chinese patients receiving elective upper abdominal surgery under general anesthesia
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| Name | Affiliation | Role |
|---|---|---|
| Zhang Xianwei, Doctor | Huazhong University of Science and Technology | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology | Wuhan | Hubei | 430030 | China |
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| ID | Title | Description |
|---|---|---|
| FG000 | Mutant Alleles | grouped by SCN9A mutant alleles including 3312T, 1719R, 1150W. |
| FG001 | Wild-type Alleles | grouped by SCN9A wild-type alleles including 3312G, 1719C, 1150R. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Mutant Alleles | grouped by SCN9A mutant alleles including 3312T, 1719R, 1150W. |
| BG001 | Wild-type Alleles | grouped by SCN9A wild-type alleles including 3312G, 1719C, 1150R. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Opioid Consumption Dose 48h After Operation. | Posted | Mean | Standard Deviation | microgramme | 48 hours after the operation |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mutant Alleles | grouped by SCN9A mutant alleles including 3312T, 1719R, 1150W. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Xianwei Zhang | Huazhong University of Science&Technology | 13037154560 | znpain@sina.com |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
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Heparin anti-coagulated blood (2 ml) was collected from the central venous during the operation and all blood samples were stored at -80℃. Genomic DNA was extracted from the blood samples using a guanidinium isothiocyanate method.
| 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. |
| 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. | 12 hours before the operation |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | units on a scale | 48 hours after the operation |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | kg/cm2 | 12 hours before the operation |
|
|
|
| Primary | PCA Press Frequency 48h After Operation. | Posted | Mean | Standard Deviation | presses per day | 48 hours after the operation |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | kg/cm2 | 12 hours before the operation |
|
|
|
| 0 |
| 22 |
| 0 |
| 22 |
| EG001 | Wild-type Alleles | grouped by SCN9A wild-type alleles including 3312G, 1719C, 1150R. | 0 | 178 | 0 | 178 |
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| D010335 | Pathologic Processes |