Gastrostomy
Conditions
Keywords
transversus abdominal plane block, epidural anesthesia, stress response, anesthetic recovery
Brief summary
This study evaluates the effect of transversus abdominis plane(TAP) block combined with general anesthesia on perioperative stress response in patients undergoing radical gastrectomy. One third of participants will receive TAP block combined with general anesthesia, another one third of participants will receive epidural anesthesia combined with general anesthesia, while the rest will receive only general anesthesia.
Detailed description
Clinically, combining epidural with general anaesthesia may confer many advantages to patients undergoing major thoracic, abdominal or orthopaedic surgery. Epidural anaesthesia can attenuate sympathetic hyperactivity and the stress response, maintain bowel peristalsis, spare the use of opioids, and facilitate postoperative feeding and physiotherapy. However, establishing epidural anesthesia is not without risks and contraindications, including refusal by the patient, technical failure, unintentional dural puncture, waist and back pain and local anaesthetic toxicity. When neurologic complications do occur, the resulting morbidity and mortality is considerable. Transversus abdominis plane (TAP) block, is another new regional anesthesia technique, has been introduced as an abdominal wall block capable of providing effective analgesia, reducing opioid consumption, and lessening opioid-related side effects. In addition,TAP block, somewhat as a pre-emptive analgesia approach, is a way of pain intervention before noxious stimulation which has been reported to be potent to attenuate the stress response. Although the analgesia efficiency of TAP block has been widely studied, its effectiveness to suppress stress response has little comparison with classic epidural block and general anesthesia. Unlike epidural anaesthesia, TAP block is easy to administer and lower incidence for side-effects.The investigators hypothesize that the TAP block reduces the stress response of surgery to the similar extent to epidural anaesthesia when combined with a standard general anaesthesia for abdominal surgery.
Interventions
Participants in this group receive ultrasound-guided TAP block under bilateral costal margin with multiple injections of 40ml 0.375% ropivacaine after the induction of general anesthesia, 30 minutes later the surgery will be started.
Participants in the Epidural group receive a epidural block (T8-9) with 2 mL of 1.6% lidocaine as a test dose before induction. After a successful placement of epidural catheter, the block then is established with 5 mL of 0.375% ropivacaine and continous infusion of 0.375% ropivacaine(5 mL/h) during the surgery.
The Control group receives standard IV-inhaled general anesthesia.
Sponsors
Study design
Eligibility
Inclusion criteria
* Consent * ASA 1-3 * No contraindication to epidural or ropivacaine * First time surgery for current conditions * Not on chronic pain medications or sedative
Exclusion criteria
* The subject has a known or suspected allergy to opioid analgesics or ropivacaine * Emergency patients * The subject has know central nervous system disease or neurological impairment * The subject has preoperative infection, and a history of immune and endocrine system disease, chemotherapy, or blood transfusion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physiological Parameters: Plasma Concentration of Norepinephrine (NE) | up to 48h after surgery | Venous blood samples will be collected at certain time points. The blood samples are collected in a pre-chilled tubes in ice and are centrifuged within 90min, and then separated plasma are stored at -80°C until analysis. The NE levels are measured by ELISA kits. |
| Physiological Parameters: Plasma Concentration of Epinephrine (E) | up to 48h after surgery | Venous blood samples will be collected at certain time points. The blood samples are collected in a pre-chilled tubes in ice and are centrifuged within 90min, and then separated plasma are stored at -80°C until analysis. The E levels are measured by ELISA kits. |
| Physiological Parameters: Plasma Concentration of Cortisol (Cor) | up to 48h after surgery | Venous blood samples will be collected at certain time points. The blood samples are collected in a pre-chilled tubes in ice and are centrifuged within 90min, and then separated plasma are stored at -80°C until analysis. The Cor levels are measured by ELISA kits. |
| Physiological Parameters: Plasma Concentration of Glucose (Glu) | up to 48h after surgery | When venous blood are collected, glucose levels are measured immediately by Glucometer. |
| Hemodynamic Parameters: Heart Rate. | up to 48h after surgery | Continuous monitoring of heart rate to 48 hours after surgery. |
| Hemodynamic Parameters: Mean Arterial Pressure(MAP) | up to 48h after surgery | Continuous monitoring of mean arterial pressure(MAP) to 48 hours after surgery. mean arterial pressure(MAP)= (systolic blood pressure+2×diastolic blood pressure)/3 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Side Effects: Number of Participants With Nausea | up to 48h after surgery | The state of nausea was evaluated after surgery during first postoperative 48 hours. |
| Anesthetics Consumption: Sufentanil Consumption | during operation | Intraoperative superaddition of sufentanil was measured. |
| Side Effects: Number of Participants With Vomiting | up to 48h after surgery | The state of vomiting was evaluated after surgery during first postoperative 48 hours. |
| Questionnaire: Pain Scores at Rest | 1hr, 6hr, 12hr, 24hr, and 48hr after surgery | Pain scores of the participants will be measured by the Visual Analogue Scale. Measurement of VAS: Draw a 10cm horizontal line on the paper. The VAS were anchored at 0cm(no pain) and 10cm(worst possible pain), the middle part shows varying degrees of pain, the greater of the number, the worse of the pain. |
| Questionnaire: Pain Scores on Movement | 1hr, 6hr, 12hr, 24hr, and 48hr after surgery | Pain scores of the participants will be measured by the Visual Analogue Scale. Measurement of VAS: Draw a 10cm horizontal line on the paper. The VAS were anchored at 0cm(no pain) and 10cm(worst possible pain), the middle part shows varying degrees of pain, the greater of the number, the worse of the pain. |
| Anesthesia Recovery: the Time of First Flatus | Through study completion, an average of 2 weeks | The time of first flatus was measured after surgery. |
| Anesthesia Recovery: Number of Participants With Prolonged Hospitalization | Through study completion, an average of 2 weeks | The percentage of long hospitalization were measured. More than 7 days after surgery is defined as prolonged hospitalization. |
| Side Effects: Number of Participants With Sedation | up to 48h after surgery | The state of sedation was evaluated after surgery during first postoperative 48 hours. |
Countries
China
Participant flow
Pre-assignment details
According to the analysis by PASS 11.0, at lease 25 participants each arm were needed.Taking into account the withdrawal of patients in the middle of the study, each group were more than a few included
Participants by arm
| Arm | Count |
|---|---|
| Transversus Abdominis Plane Block The TAP group receives ultrasound-guided TAP block under bilateral costal margin with multiple injections of 40ml 0.375% ropivacaine after the induction of general anesthesia.
Transversus abdominis plane block: Participants in this group receive ultrasound-guided TAP block under bilateral costal margin with multiple injections of 40ml 0.375% ropivacaine after the induction of general anesthesia, 30 minutes later the surgery will be started. | 30 |
| Epidural Anesthesia The Epidural group receives epidural block (T8-9) 2 mL of 1.6% lidocaine as a test dose and continous infusion of 0.375% ropivacaine(5 mL/h) during the surgery.
Epidural anesthesia: Participants in the Epidural group receive a epidural block (T8-9) with 2 mL of 1.6% lidocaine as a test dose before induction. After a successful placement of epidural catheter, the block then is established with 5 mL of 0.375% ropivacaine and continous infusion of 0.375% ropivacaine(5 mL/h) during the surgery. | 28 |
| Control The Control group receives standard IV-inhaled general anesthesia.
control: The Control group receives standard IV-inhaled general anesthesia. | 31 |
| Total | 89 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Puncture failed | 0 | 2 | 0 |
Baseline characteristics
| Characteristic | Transversus Abdominis Plane Block | Epidural Anesthesia | Control | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 8 Participants | 8 Participants | 10 Participants | 26 Participants |
| Age, Categorical Between 18 and 65 years | 22 Participants | 20 Participants | 21 Participants | 63 Participants |
| Age, Continuous | 56.75 years STANDARD_DEVIATION 8.24 | 58.60 years STANDARD_DEVIATION 8.72 | 60.20 years STANDARD_DEVIATION 9.43 | 59.18 years STANDARD_DEVIATION 9.02 |
| ASA physical status I | 5 Participants | 4 Participants | 4 Participants | 13 Participants |
| ASA physical status II | 19 Participants | 18 Participants | 20 Participants | 57 Participants |
| ASA physical status III | 6 Participants | 6 Participants | 7 Participants | 19 Participants |
| Race/Ethnicity, Customized Asian | 30 participants | 28 participants | 31 participants | 89 participants |
| Sex: Female, Male Female | 9 Participants | 8 Participants | 8 Participants | 25 Participants |
| Sex: Female, Male Male | 21 Participants | 20 Participants | 23 Participants | 64 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 28 | 0 / 31 |
| other Total, other adverse events | 0 / 30 | 2 / 28 | 0 / 31 |
| serious Total, serious adverse events | 0 / 30 | 0 / 28 | 0 / 31 |
Outcome results
Hemodynamic Parameters: Heart Rate.
Continuous monitoring of heart rate to 48 hours after surgery.
Time frame: up to 48h after surgery
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Transversus Abdominis Plane Block | Hemodynamic Parameters: Heart Rate. | Extubation | 82 bpm | Standard Deviation 13.5 |
| Transversus Abdominis Plane Block | Hemodynamic Parameters: Heart Rate. | Intubation | 88.4 bpm | Standard Deviation 11.5 |
| Transversus Abdominis Plane Block | Hemodynamic Parameters: Heart Rate. | 48 hr after surgery | 75.8 bpm | Standard Deviation 10.3 |
| Transversus Abdominis Plane Block | Hemodynamic Parameters: Heart Rate. | Incision | 80 bpm | Standard Deviation 11.4 |
| Transversus Abdominis Plane Block | Hemodynamic Parameters: Heart Rate. | 24 hr after surgery | 75 bpm | Standard Deviation 10.9 |
| Transversus Abdominis Plane Block | Hemodynamic Parameters: Heart Rate. | Before induction | 74.8 bpm | Standard Deviation 10.9 |
| Transversus Abdominis Plane Block | Hemodynamic Parameters: Heart Rate. | Baseline | 75.4 bpm | Standard Deviation 12.5 |
| Transversus Abdominis Plane Block | Hemodynamic Parameters: Heart Rate. | 6 hr after surgery | 77 bpm | Standard Deviation 10.5 |
| Transversus Abdominis Plane Block | Hemodynamic Parameters: Heart Rate. | Induction | 71.1 bpm | Standard Deviation 10.8 |
| Epidural Anesthesia | Hemodynamic Parameters: Heart Rate. | Induction | 63.1 bpm | Standard Deviation 10.3 |
| Epidural Anesthesia | Hemodynamic Parameters: Heart Rate. | Baseline | 77.1 bpm | Standard Deviation 11.1 |
| Epidural Anesthesia | Hemodynamic Parameters: Heart Rate. | Before induction | 70 bpm | Standard Deviation 12.2 |
| Epidural Anesthesia | Hemodynamic Parameters: Heart Rate. | Intubation | 87 bpm | Standard Deviation 13 |
| Epidural Anesthesia | Hemodynamic Parameters: Heart Rate. | Incision | 78 bpm | Standard Deviation 11.5 |
| Epidural Anesthesia | Hemodynamic Parameters: Heart Rate. | Extubation | 80 bpm | Standard Deviation 13 |
| Epidural Anesthesia | Hemodynamic Parameters: Heart Rate. | 6 hr after surgery | 75 bpm | Standard Deviation 10 |
| Epidural Anesthesia | Hemodynamic Parameters: Heart Rate. | 24 hr after surgery | 74 bpm | Standard Deviation 11 |
| Epidural Anesthesia | Hemodynamic Parameters: Heart Rate. | 48 hr after surgery | 75 bpm | Standard Deviation 10.5 |
| Control | Hemodynamic Parameters: Heart Rate. | Extubation | 85 bpm | Standard Deviation 15 |
| Control | Hemodynamic Parameters: Heart Rate. | Before induction | 76 bpm | Standard Deviation 11 |
| Control | Hemodynamic Parameters: Heart Rate. | 6 hr after surgery | 79 bpm | Standard Deviation 12 |
| Control | Hemodynamic Parameters: Heart Rate. | Baseline | 76.4 bpm | Standard Deviation 12 |
| Control | Hemodynamic Parameters: Heart Rate. | Intubation | 92 bpm | Standard Deviation 13.5 |
| Control | Hemodynamic Parameters: Heart Rate. | 48 hr after surgery | 79.5 bpm | Standard Deviation 11.5 |
| Control | Hemodynamic Parameters: Heart Rate. | Incision | 95.7 bpm | Standard Deviation 13.3 |
| Control | Hemodynamic Parameters: Heart Rate. | Induction | 71.7 bpm | Standard Deviation 10.2 |
| Control | Hemodynamic Parameters: Heart Rate. | 24 hr after surgery | 81.3 bpm | Standard Deviation 10.8 |
Hemodynamic Parameters: Mean Arterial Pressure(MAP)
Continuous monitoring of mean arterial pressure(MAP) to 48 hours after surgery. mean arterial pressure(MAP)= (systolic blood pressure+2×diastolic blood pressure)/3
Time frame: up to 48h after surgery
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Transversus Abdominis Plane Block | Hemodynamic Parameters: Mean Arterial Pressure(MAP) | Intubation | 93 mmHg | Standard Deviation 13.5 |
| Transversus Abdominis Plane Block | Hemodynamic Parameters: Mean Arterial Pressure(MAP) | 48 hr after surgery | 89 mmHg | Standard Deviation 12 |
| Transversus Abdominis Plane Block | Hemodynamic Parameters: Mean Arterial Pressure(MAP) | Extubation | 88 mmHg | Standard Deviation 13.5 |
| Transversus Abdominis Plane Block | Hemodynamic Parameters: Mean Arterial Pressure(MAP) | Incision | 85 mmHg | Standard Deviation 12 |
| Transversus Abdominis Plane Block | Hemodynamic Parameters: Mean Arterial Pressure(MAP) | Baseline | 87 mmHg | Standard Deviation 12.5 |
| Transversus Abdominis Plane Block | Hemodynamic Parameters: Mean Arterial Pressure(MAP) | 24 hr after surgery | 88 mmHg | Standard Deviation 12.5 |
| Transversus Abdominis Plane Block | Hemodynamic Parameters: Mean Arterial Pressure(MAP) | Induction | 81 mmHg | Standard Deviation 10.5 |
| Transversus Abdominis Plane Block | Hemodynamic Parameters: Mean Arterial Pressure(MAP) | Before induction | 90 mmHg | Standard Deviation 13 |
| Transversus Abdominis Plane Block | Hemodynamic Parameters: Mean Arterial Pressure(MAP) | 6 hr after surgery | 89 mmHg | Standard Deviation 10.5 |
| Epidural Anesthesia | Hemodynamic Parameters: Mean Arterial Pressure(MAP) | Incision | 84 mmHg | Standard Deviation 11.5 |
| Epidural Anesthesia | Hemodynamic Parameters: Mean Arterial Pressure(MAP) | Baseline | 88.5 mmHg | Standard Deviation 11 |
| Epidural Anesthesia | Hemodynamic Parameters: Mean Arterial Pressure(MAP) | Before induction | 80 mmHg | Standard Deviation 12 |
| Epidural Anesthesia | Hemodynamic Parameters: Mean Arterial Pressure(MAP) | Induction | 73 mmHg | Standard Deviation 12 |
| Epidural Anesthesia | Hemodynamic Parameters: Mean Arterial Pressure(MAP) | Intubation | 90 mmHg | Standard Deviation 15 |
| Epidural Anesthesia | Hemodynamic Parameters: Mean Arterial Pressure(MAP) | Extubation | 90 mmHg | Standard Deviation 13 |
| Epidural Anesthesia | Hemodynamic Parameters: Mean Arterial Pressure(MAP) | 6 hr after surgery | 86 mmHg | Standard Deviation 10 |
| Epidural Anesthesia | Hemodynamic Parameters: Mean Arterial Pressure(MAP) | 24 hr after surgery | 84 mmHg | Standard Deviation 11 |
| Epidural Anesthesia | Hemodynamic Parameters: Mean Arterial Pressure(MAP) | 48 hr after surgery | 85 mmHg | Standard Deviation 10.5 |
| Control | Hemodynamic Parameters: Mean Arterial Pressure(MAP) | Induction | 80 mmHg | Standard Deviation 13 |
| Control | Hemodynamic Parameters: Mean Arterial Pressure(MAP) | Baseline | 86 mmHg | Standard Deviation 12 |
| Control | Hemodynamic Parameters: Mean Arterial Pressure(MAP) | 6 hr after surgery | 93 mmHg | Standard Deviation 12 |
| Control | Hemodynamic Parameters: Mean Arterial Pressure(MAP) | Before induction | 87 mmHg | Standard Deviation 13 |
| Control | Hemodynamic Parameters: Mean Arterial Pressure(MAP) | 48 hr after surgery | 90 mmHg | Standard Deviation 11.5 |
| Control | Hemodynamic Parameters: Mean Arterial Pressure(MAP) | Incision | 98 mmHg | Standard Deviation 15 |
| Control | Hemodynamic Parameters: Mean Arterial Pressure(MAP) | Intubation | 94 mmHg | Standard Deviation 15.5 |
| Control | Hemodynamic Parameters: Mean Arterial Pressure(MAP) | 24 hr after surgery | 90 mmHg | Standard Deviation 14 |
| Control | Hemodynamic Parameters: Mean Arterial Pressure(MAP) | Extubation | 95 mmHg | Standard Deviation 15 |
Physiological Parameters: Plasma Concentration of Cortisol (Cor)
Venous blood samples will be collected at certain time points. The blood samples are collected in a pre-chilled tubes in ice and are centrifuged within 90min, and then separated plasma are stored at -80°C until analysis. The Cor levels are measured by ELISA kits.
Time frame: up to 48h after surgery
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Transversus Abdominis Plane Block | Physiological Parameters: Plasma Concentration of Cortisol (Cor) | 24 hr after surgery | 439 mmol/L | Standard Deviation 116 |
| Transversus Abdominis Plane Block | Physiological Parameters: Plasma Concentration of Cortisol (Cor) | 6 hr after surgery | 519.2 mmol/L | Standard Deviation 156.6 |
| Transversus Abdominis Plane Block | Physiological Parameters: Plasma Concentration of Cortisol (Cor) | Baseline | 273.3 mmol/L | Standard Deviation 93 |
| Transversus Abdominis Plane Block | Physiological Parameters: Plasma Concentration of Cortisol (Cor) | 0 hr after surgery | 430.4 mmol/L | Standard Deviation 152.1 |
| Transversus Abdominis Plane Block | Physiological Parameters: Plasma Concentration of Cortisol (Cor) | 48 hr after surgery | 320.6 mmol/L | Standard Deviation 112.3 |
| Epidural Anesthesia | Physiological Parameters: Plasma Concentration of Cortisol (Cor) | 6 hr after surgery | 464.2 mmol/L | Standard Deviation 155.8 |
| Epidural Anesthesia | Physiological Parameters: Plasma Concentration of Cortisol (Cor) | Baseline | 262.4 mmol/L | Standard Deviation 101.5 |
| Epidural Anesthesia | Physiological Parameters: Plasma Concentration of Cortisol (Cor) | 0 hr after surgery | 395.2 mmol/L | Standard Deviation 133.4 |
| Epidural Anesthesia | Physiological Parameters: Plasma Concentration of Cortisol (Cor) | 24 hr after surgery | 388.1 mmol/L | Standard Deviation 121.2 |
| Epidural Anesthesia | Physiological Parameters: Plasma Concentration of Cortisol (Cor) | 48 hr after surgery | 302.8 mmol/L | Standard Deviation 112.4 |
| Control | Physiological Parameters: Plasma Concentration of Cortisol (Cor) | 48 hr after surgery | 452.4 mmol/L | Standard Deviation 165.3 |
| Control | Physiological Parameters: Plasma Concentration of Cortisol (Cor) | 24 hr after surgery | 713.8 mmol/L | Standard Deviation 190 |
| Control | Physiological Parameters: Plasma Concentration of Cortisol (Cor) | Baseline | 286.3 mmol/L | Standard Deviation 106.6 |
| Control | Physiological Parameters: Plasma Concentration of Cortisol (Cor) | 6 hr after surgery | 698.3 mmol/L | Standard Deviation 188.1 |
| Control | Physiological Parameters: Plasma Concentration of Cortisol (Cor) | 0 hr after surgery | 516.1 mmol/L | Standard Deviation 162.3 |
Physiological Parameters: Plasma Concentration of Epinephrine (E)
Venous blood samples will be collected at certain time points. The blood samples are collected in a pre-chilled tubes in ice and are centrifuged within 90min, and then separated plasma are stored at -80°C until analysis. The E levels are measured by ELISA kits.
Time frame: up to 48h after surgery
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Transversus Abdominis Plane Block | Physiological Parameters: Plasma Concentration of Epinephrine (E) | 24 hr after surgery | 44.5 pg/ml | Standard Deviation 7 |
| Transversus Abdominis Plane Block | Physiological Parameters: Plasma Concentration of Epinephrine (E) | 6 hr after surgery | 45.3 pg/ml | Standard Deviation 8.2 |
| Transversus Abdominis Plane Block | Physiological Parameters: Plasma Concentration of Epinephrine (E) | Baseline | 33.2 pg/ml | Standard Deviation 6 |
| Transversus Abdominis Plane Block | Physiological Parameters: Plasma Concentration of Epinephrine (E) | 0 hr after surgery | 41.5 pg/ml | Standard Deviation 6.6 |
| Transversus Abdominis Plane Block | Physiological Parameters: Plasma Concentration of Epinephrine (E) | 48 hr after surgery | 40.6 pg/ml | Standard Deviation 6.3 |
| Epidural Anesthesia | Physiological Parameters: Plasma Concentration of Epinephrine (E) | 6 hr after surgery | 46.4 pg/ml | Standard Deviation 7.5 |
| Epidural Anesthesia | Physiological Parameters: Plasma Concentration of Epinephrine (E) | Baseline | 35 pg/ml | Standard Deviation 5.4 |
| Epidural Anesthesia | Physiological Parameters: Plasma Concentration of Epinephrine (E) | 0 hr after surgery | 40.5 pg/ml | Standard Deviation 7.2 |
| Epidural Anesthesia | Physiological Parameters: Plasma Concentration of Epinephrine (E) | 24 hr after surgery | 41.8 pg/ml | Standard Deviation 6.2 |
| Epidural Anesthesia | Physiological Parameters: Plasma Concentration of Epinephrine (E) | 48 hr after surgery | 39.3 pg/ml | Standard Deviation 5.2 |
| Control | Physiological Parameters: Plasma Concentration of Epinephrine (E) | 48 hr after surgery | 48.7 pg/ml | Standard Deviation 7.6 |
| Control | Physiological Parameters: Plasma Concentration of Epinephrine (E) | 24 hr after surgery | 59.1 pg/ml | Standard Deviation 8.5 |
| Control | Physiological Parameters: Plasma Concentration of Epinephrine (E) | Baseline | 34.4 pg/ml | Standard Deviation 6.1 |
| Control | Physiological Parameters: Plasma Concentration of Epinephrine (E) | 6 hr after surgery | 52.3 pg/ml | Standard Deviation 8.1 |
| Control | Physiological Parameters: Plasma Concentration of Epinephrine (E) | 0 hr after surgery | 42.2 pg/ml | Standard Deviation 7 |
Physiological Parameters: Plasma Concentration of Glucose (Glu)
When venous blood are collected, glucose levels are measured immediately by Glucometer.
Time frame: up to 48h after surgery
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Transversus Abdominis Plane Block | Physiological Parameters: Plasma Concentration of Glucose (Glu) | 24 hr after surgery | 6.5 mmol/L | Standard Deviation 0.8 |
| Transversus Abdominis Plane Block | Physiological Parameters: Plasma Concentration of Glucose (Glu) | 6 hr after surgery | 7.5 mmol/L | Standard Deviation 1 |
| Transversus Abdominis Plane Block | Physiological Parameters: Plasma Concentration of Glucose (Glu) | Baseline | 5 mmol/L | Standard Deviation 0.5 |
| Transversus Abdominis Plane Block | Physiological Parameters: Plasma Concentration of Glucose (Glu) | 0 hr after surgery | 8.2 mmol/L | Standard Deviation 1.2 |
| Transversus Abdominis Plane Block | Physiological Parameters: Plasma Concentration of Glucose (Glu) | 48 hr after surgery | 5.5 mmol/L | Standard Deviation 0.4 |
| Epidural Anesthesia | Physiological Parameters: Plasma Concentration of Glucose (Glu) | 6 hr after surgery | 7 mmol/L | Standard Deviation 0.9 |
| Epidural Anesthesia | Physiological Parameters: Plasma Concentration of Glucose (Glu) | Baseline | 5.2 mmol/L | Standard Deviation 0.5 |
| Epidural Anesthesia | Physiological Parameters: Plasma Concentration of Glucose (Glu) | 0 hr after surgery | 7.7 mmol/L | Standard Deviation 0.9 |
| Epidural Anesthesia | Physiological Parameters: Plasma Concentration of Glucose (Glu) | 24 hr after surgery | 6.3 mmol/L | Standard Deviation 0.7 |
| Epidural Anesthesia | Physiological Parameters: Plasma Concentration of Glucose (Glu) | 48 hr after surgery | 5.2 mmol/L | Standard Deviation 0.5 |
| Control | Physiological Parameters: Plasma Concentration of Glucose (Glu) | 48 hr after surgery | 5.8 mmol/L | Standard Deviation 0.6 |
| Control | Physiological Parameters: Plasma Concentration of Glucose (Glu) | 24 hr after surgery | 8.6 mmol/L | Standard Deviation 1.5 |
| Control | Physiological Parameters: Plasma Concentration of Glucose (Glu) | Baseline | 5.5 mmol/L | Standard Deviation 0.4 |
| Control | Physiological Parameters: Plasma Concentration of Glucose (Glu) | 6 hr after surgery | 10.8 mmol/L | Standard Deviation 1.9 |
| Control | Physiological Parameters: Plasma Concentration of Glucose (Glu) | 0 hr after surgery | 10.5 mmol/L | Standard Deviation 1.5 |
Physiological Parameters: Plasma Concentration of Norepinephrine (NE)
Venous blood samples will be collected at certain time points. The blood samples are collected in a pre-chilled tubes in ice and are centrifuged within 90min, and then separated plasma are stored at -80°C until analysis. The NE levels are measured by ELISA kits.
Time frame: up to 48h after surgery
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Transversus Abdominis Plane Block | Physiological Parameters: Plasma Concentration of Norepinephrine (NE) | 24 hr after surgery | 150.5 pg/ml | Standard Deviation 30.9 |
| Transversus Abdominis Plane Block | Physiological Parameters: Plasma Concentration of Norepinephrine (NE) | 6 hr after surgery | 172.3 pg/ml | Standard Deviation 32.7 |
| Transversus Abdominis Plane Block | Physiological Parameters: Plasma Concentration of Norepinephrine (NE) | Baseline | 145.6 pg/ml | Standard Deviation 25.8 |
| Transversus Abdominis Plane Block | Physiological Parameters: Plasma Concentration of Norepinephrine (NE) | 0 hr after surgery | 170.2 pg/ml | Standard Deviation 33.4 |
| Transversus Abdominis Plane Block | Physiological Parameters: Plasma Concentration of Norepinephrine (NE) | 48 hr after surgery | 135.7 pg/ml | Standard Deviation 29.8 |
| Epidural Anesthesia | Physiological Parameters: Plasma Concentration of Norepinephrine (NE) | 6 hr after surgery | 163.2 pg/ml | Standard Deviation 32.4 |
| Epidural Anesthesia | Physiological Parameters: Plasma Concentration of Norepinephrine (NE) | Baseline | 150.9 pg/ml | Standard Deviation 33.2 |
| Epidural Anesthesia | Physiological Parameters: Plasma Concentration of Norepinephrine (NE) | 0 hr after surgery | 165.5 pg/ml | Standard Deviation 36.6 |
| Epidural Anesthesia | Physiological Parameters: Plasma Concentration of Norepinephrine (NE) | 24 hr after surgery | 155.8 pg/ml | Standard Deviation 25.3 |
| Epidural Anesthesia | Physiological Parameters: Plasma Concentration of Norepinephrine (NE) | 48 hr after surgery | 140.6 pg/ml | Standard Deviation 24.8 |
| Control | Physiological Parameters: Plasma Concentration of Norepinephrine (NE) | 48 hr after surgery | 165.2 pg/ml | Standard Deviation 32.7 |
| Control | Physiological Parameters: Plasma Concentration of Norepinephrine (NE) | 24 hr after surgery | 175.4 pg/ml | Standard Deviation 40.2 |
| Control | Physiological Parameters: Plasma Concentration of Norepinephrine (NE) | Baseline | 153.1 pg/ml | Standard Deviation 35.2 |
| Control | Physiological Parameters: Plasma Concentration of Norepinephrine (NE) | 6 hr after surgery | 215.5 pg/ml | Standard Deviation 50.3 |
| Control | Physiological Parameters: Plasma Concentration of Norepinephrine (NE) | 0 hr after surgery | 177.9 pg/ml | Standard Deviation 43.2 |
Anesthesia Recovery: Number of Participants With Prolonged Hospitalization
The percentage of long hospitalization were measured. More than 7 days after surgery is defined as prolonged hospitalization.
Time frame: Through study completion, an average of 2 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Transversus Abdominis Plane Block | Anesthesia Recovery: Number of Participants With Prolonged Hospitalization | 5 participants |
| Epidural Anesthesia | Anesthesia Recovery: Number of Participants With Prolonged Hospitalization | 5 participants |
| Control | Anesthesia Recovery: Number of Participants With Prolonged Hospitalization | 13 participants |
Anesthesia Recovery: the Time of First Flatus
The time of first flatus was measured after surgery.
Time frame: Through study completion, an average of 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Transversus Abdominis Plane Block | Anesthesia Recovery: the Time of First Flatus | 77.6 hour | Standard Deviation 10.4 |
| Epidural Anesthesia | Anesthesia Recovery: the Time of First Flatus | 78.4 hour | Standard Deviation 11.6 |
| Control | Anesthesia Recovery: the Time of First Flatus | 81.6 hour | Standard Deviation 10.4 |
Anesthetics Consumption: Sufentanil Consumption
Intraoperative superaddition of sufentanil was measured.
Time frame: during operation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Transversus Abdominis Plane Block | Anesthetics Consumption: Sufentanil Consumption | 4.3 ug | Standard Deviation 1.5 |
| Epidural Anesthesia | Anesthetics Consumption: Sufentanil Consumption | 3.6 ug | Standard Deviation 1.2 |
| Control | Anesthetics Consumption: Sufentanil Consumption | 10.2 ug | Standard Deviation 2.8 |
Questionnaire: Pain Scores at Rest
Pain scores of the participants will be measured by the Visual Analogue Scale. Measurement of VAS: Draw a 10cm horizontal line on the paper. The VAS were anchored at 0cm(no pain) and 10cm(worst possible pain), the middle part shows varying degrees of pain, the greater of the number, the worse of the pain.
Time frame: 1hr, 6hr, 12hr, 24hr, and 48hr after surgery
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Transversus Abdominis Plane Block | Questionnaire: Pain Scores at Rest | 24 hr | 2.2 units on a scale | Standard Deviation 0.6 |
| Transversus Abdominis Plane Block | Questionnaire: Pain Scores at Rest | 12 hr | 2.0 units on a scale | Standard Deviation 0.7 |
| Transversus Abdominis Plane Block | Questionnaire: Pain Scores at Rest | 1 hr | 2.2 units on a scale | Standard Deviation 0.7 |
| Transversus Abdominis Plane Block | Questionnaire: Pain Scores at Rest | 6 hr | 2.2 units on a scale | Standard Deviation 0.9 |
| Transversus Abdominis Plane Block | Questionnaire: Pain Scores at Rest | 48 hr | 1.0 units on a scale | Standard Deviation 0.8 |
| Epidural Anesthesia | Questionnaire: Pain Scores at Rest | 12 hr | 1.7 units on a scale | Standard Deviation 0.7 |
| Epidural Anesthesia | Questionnaire: Pain Scores at Rest | 1 hr | 1.8 units on a scale | Standard Deviation 1 |
| Epidural Anesthesia | Questionnaire: Pain Scores at Rest | 6 hr | 1.9 units on a scale | Standard Deviation 0.8 |
| Epidural Anesthesia | Questionnaire: Pain Scores at Rest | 24 hr | 1.3 units on a scale | Standard Deviation 0.6 |
| Epidural Anesthesia | Questionnaire: Pain Scores at Rest | 48 hr | 0.9 units on a scale | Standard Deviation 0.6 |
| Control | Questionnaire: Pain Scores at Rest | 48 hr | 1.3 units on a scale | Standard Deviation 0.8 |
| Control | Questionnaire: Pain Scores at Rest | 24 hr | 2.7 units on a scale | Standard Deviation 1 |
| Control | Questionnaire: Pain Scores at Rest | 1 hr | 2.7 units on a scale | Standard Deviation 0.6 |
| Control | Questionnaire: Pain Scores at Rest | 12 hr | 2.8 units on a scale | Standard Deviation 1 |
| Control | Questionnaire: Pain Scores at Rest | 6 hr | 2.7 units on a scale | Standard Deviation 1 |
Questionnaire: Pain Scores on Movement
Pain scores of the participants will be measured by the Visual Analogue Scale. Measurement of VAS: Draw a 10cm horizontal line on the paper. The VAS were anchored at 0cm(no pain) and 10cm(worst possible pain), the middle part shows varying degrees of pain, the greater of the number, the worse of the pain.
Time frame: 1hr, 6hr, 12hr, 24hr, and 48hr after surgery
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Transversus Abdominis Plane Block | Questionnaire: Pain Scores on Movement | 24 hr | 4.1 units on a scale | Standard Deviation 0.7 |
| Transversus Abdominis Plane Block | Questionnaire: Pain Scores on Movement | 12 hr | 3.3 units on a scale | Standard Deviation 0.5 |
| Transversus Abdominis Plane Block | Questionnaire: Pain Scores on Movement | 1 hr | 2.7 units on a scale | Standard Deviation 1.2 |
| Transversus Abdominis Plane Block | Questionnaire: Pain Scores on Movement | 6 hr | 2.9 units on a scale | Standard Deviation 0.7 |
| Transversus Abdominis Plane Block | Questionnaire: Pain Scores on Movement | 48 hr | 4.2 units on a scale | Standard Deviation 0.8 |
| Epidural Anesthesia | Questionnaire: Pain Scores on Movement | 12 hr | 3.7 units on a scale | Standard Deviation 0.9 |
| Epidural Anesthesia | Questionnaire: Pain Scores on Movement | 1 hr | 2.4 units on a scale | Standard Deviation 1.1 |
| Epidural Anesthesia | Questionnaire: Pain Scores on Movement | 6 hr | 2.6 units on a scale | Standard Deviation 1.3 |
| Epidural Anesthesia | Questionnaire: Pain Scores on Movement | 24 hr | 3.5 units on a scale | Standard Deviation 0.9 |
| Epidural Anesthesia | Questionnaire: Pain Scores on Movement | 48 hr | 3.5 units on a scale | Standard Deviation 0.8 |
| Control | Questionnaire: Pain Scores on Movement | 48 hr | 4.5 units on a scale | Standard Deviation 0.9 |
| Control | Questionnaire: Pain Scores on Movement | 24 hr | 4.6 units on a scale | Standard Deviation 0.8 |
| Control | Questionnaire: Pain Scores on Movement | 1 hr | 4.3 units on a scale | Standard Deviation 0.8 |
| Control | Questionnaire: Pain Scores on Movement | 12 hr | 4.0 units on a scale | Standard Deviation 0.8 |
| Control | Questionnaire: Pain Scores on Movement | 6 hr | 4.2 units on a scale | Standard Deviation 0.7 |
Side Effects: Number of Participants With Nausea
The state of nausea was evaluated after surgery during first postoperative 48 hours.
Time frame: up to 48h after surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Transversus Abdominis Plane Block | Side Effects: Number of Participants With Nausea | 5 participants |
| Epidural Anesthesia | Side Effects: Number of Participants With Nausea | 4 participants |
| Control | Side Effects: Number of Participants With Nausea | 6 participants |
Side Effects: Number of Participants With Sedation
The state of sedation was evaluated after surgery during first postoperative 48 hours.
Time frame: up to 48h after surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Transversus Abdominis Plane Block | Side Effects: Number of Participants With Sedation | 8 participants |
| Epidural Anesthesia | Side Effects: Number of Participants With Sedation | 5 participants |
| Control | Side Effects: Number of Participants With Sedation | 16 participants |
Side Effects: Number of Participants With Vomiting
The state of vomiting was evaluated after surgery during first postoperative 48 hours.
Time frame: up to 48h after surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Transversus Abdominis Plane Block | Side Effects: Number of Participants With Vomiting | 0 participants |
| Epidural Anesthesia | Side Effects: Number of Participants With Vomiting | 1 participants |
| Control | Side Effects: Number of Participants With Vomiting | 1 participants |