Effect of Transversus Abdominis Plane Block Combined With General Anesthesia on Perioperative Stress Response in Patients Undergoing Radical Gastrectomy: A Double-blind Randomized Controlled Study.
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Gastrostomy
- Sponsor
- Jilin University
- Enrollment
- 91
- Locations
- 1
- Primary Endpoint
- Physiological Parameters: Plasma Concentration of Epinephrine (E)
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
Zhao Guoqing
Clinical Professor
Jilin University
Eligibility Criteria
Inclusion Criteria
- •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.
Outcomes
Primary Outcomes
Physiological Parameters: Plasma Concentration of Epinephrine (E)
Time Frame: 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)
Time Frame: 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.
Hemodynamic Parameters: Heart Rate.
Time Frame: up to 48h after surgery
Continuous monitoring of heart rate to 48 hours after surgery.
Physiological Parameters: Plasma Concentration of Norepinephrine (NE)
Time Frame: 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 Glucose (Glu)
Time Frame: up to 48h after surgery
When venous blood are collected, glucose levels are measured immediately by Glucometer.
Hemodynamic Parameters: Mean Arterial Pressure(MAP)
Time Frame: 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 Outcomes
- Side Effects: Number of Participants With Sedation(up to 48h after surgery)
- Side Effects: Number of Participants With Vomiting(up to 48h after surgery)
- Anesthetics Consumption: Sufentanil Consumption(during operation)
- Questionnaire: Pain Scores on Movement(1hr, 6hr, 12hr, 24hr, and 48hr after surgery)
- Side Effects: Number of Participants With Nausea(up to 48h after surgery)
- Anesthesia Recovery: the Time of First Flatus(Through study completion, an average of 2 weeks)
- Questionnaire: Pain Scores at Rest(1hr, 6hr, 12hr, 24hr, and 48hr after surgery)
- Anesthesia Recovery: Number of Participants With Prolonged Hospitalization(Through study completion, an average of 2 weeks)