N/A
Completed N=91
Transversus Abdominis Plane Block on Stress Response
Gastrostomy
Source: ClinicalTrials.gov NCT03035916 ↗
Enrolled (actual)
91
Serious AEs
0.0%
Results posted
Dec 2017
Primary outcomePrimary: Physiological Parameters: Plasma Concentration of Norepinephrine (NE) — 145.6; 150.9; 153.1; 170.2 pg/ml — p=0.454
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Physiological Parameters: Plasma Concentration of Norepinephrine (NE) |
145.6; 150.9; 153.1; 170.2; 165.5; 177.9 | 0.454 |
| PRIMARY Physiological Parameters: Plasma Concentration of Epinephrine (E) |
33.2; 35; 34.4; 41.5; 40.5; 42.2 | 0.412 |
| PRIMARY Physiological Parameters: Plasma Concentration of Cortisol (Cor) |
273.3; 262.4; 286.3; 430.4; 395.2; 516.1 | 0.673 |
| PRIMARY Physiological Parameters: Plasma Concentration of Glucose (Glu) |
5; 5.2; 5.5; 8.2; 7.7; 10.5 | 0.249 |
| PRIMARY Hemodynamic Parameters: Heart Rate. |
75.4; 77.1; 76.4; 74.8; 70; 76 | 0.384 |
| PRIMARY Hemodynamic Parameters: Mean Arterial Pressure(MAP) |
87; 88.5; 86; 90; 80; 87 | 0.645 |
| SECONDARY Anesthetics Consumption: Sufentanil Consumption |
4.3; 3.6; 10.2 | 0.056 |
| SECONDARY Questionnaire: Pain Scores at Rest |
2.2; 1.8; 2.7; 2.2; 1.9; 2.7 | 0.056 |
| SECONDARY Questionnaire: Pain Scores on Movement |
2.7; 2.4; 4.3; 2.9; 2.6; 4.2 | 0.176 |
| SECONDARY Anesthesia Recovery: the Time of First Flatus |
77.6; 78.4; 81.6 | 0.585 |
| SECONDARY Anesthesia Recovery: Number of Participants With Prolonged Hospitalization |
5; 5; 13 | 0.644 |
| SECONDARY Side Effects: Number of Participants With Sedation |
8; 5; 16 | 0.421 |
| SECONDARY Side Effects: Number of Participants With Nausea |
5; 4; 6 | 0.910 |
| SECONDARY Side Effects: Number of Participants With Vomiting |
0; 1; 1 | 0.972 |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03035916). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.