Pain, Surgery
Conditions
Keywords
gene polymorphism, SCN9A, pain perception, postoperative pain
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.
Interventions
None listed
Sponsors
Xianwei Zhang
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Opioid Consumption Dose 48h After Operation. | 48 hours after the operation |
| PCA Press Frequency 48h After Operation. | 48 hours after the operation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Visual Analog Scale 48h After Operation. | 48 hours after the 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 |
| Preoperative Pressure Pain Threshold (PPT) | 12 hours 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. |
| Preoperative Pressure Pain Tolerance (PTO) | 12 hours 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 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. |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Mutant Alleles grouped by SCN9A mutant alleles including 3312T, 1719R, 1150W. | 22 |
| Wild-type Alleles grouped by SCN9A wild-type alleles including 3312G, 1719C, 1150R. | 178 |
| Total | 200 |
Baseline characteristics
| Characteristic | Wild-type Alleles | Mutant Alleles | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 16 Participants | 0 Participants | 16 Participants |
| Age, Categorical Between 18 and 65 years | 162 Participants | 22 Participants | 184 Participants |
| Age, Continuous | 55.6 years STANDARD_DEVIATION 5.3 | 51.9 years STANDARD_DEVIATION 9.3 | 55.2 years STANDARD_DEVIATION 5.7 |
| Region of Enrollment China | 178 participants | 22 participants | 200 participants |
| Sex: Female, Male Female | 101 Participants | 12 Participants | 113 Participants |
| Sex: Female, Male Male | 77 Participants | 10 Participants | 87 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 22 | 0 / 178 |
| serious Total, serious adverse events | 0 / 22 | 0 / 178 |
Outcome results
Primary
Opioid Consumption Dose 48h After Operation.
Time frame: 48 hours after the operation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mutant Alleles | Opioid Consumption Dose 48h After Operation. | 37.4 microgramme | Standard Deviation 10.4 |
| Wild-type Alleles | Opioid Consumption Dose 48h After Operation. | 50.4 microgramme | Standard Deviation 20.4 |
Primary
PCA Press Frequency 48h After Operation.
Time frame: 48 hours after the operation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mutant Alleles | PCA Press Frequency 48h After Operation. | 8.8 presses per day | Standard Deviation 5.6 |
| Wild-type Alleles | PCA Press Frequency 48h After Operation. | 19.9 presses per day | Standard Deviation 12.7 |
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.
Time frame: 12 hours before the operation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mutant Alleles | Preoperative Pressure Pain Threshold (PPT) | 3.6 kg/cm2 | Standard Deviation 1 |
| Wild-type Alleles | Preoperative Pressure Pain Threshold (PPT) | 3.7 kg/cm2 | Standard Deviation 1.8 |
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.
Time frame: 12 hours before the operation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mutant Alleles | Preoperative Pressure Pain Tolerance (PTO) | 6.6 kg/cm2 | Standard Deviation 3.6 |
| Wild-type Alleles | Preoperative Pressure Pain Tolerance (PTO) | 6.5 kg/cm2 | Standard Deviation 2.6 |
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
Time frame: 48 hours after the operation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mutant Alleles | The Visual Analog Scale 48h After Operation. | 6.9 units on a scale | Standard Deviation 2.5 |
| Wild-type Alleles | The Visual Analog Scale 48h After Operation. | 5.0 units on a scale | Standard Deviation 1.7 |