Transversus Abdominis Plane Block on Stress Response

Not Applicable

Completed

Conditions: Gastrostomy

Interventions: Other: Transversus abdominis plane block
Other: Epidural anesthesia
Other: control

Registration Number: NCT03035916

Lead Sponsor: Jilin University

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 91

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transversus abdominis plane block	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.
Epidural anesthesia	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.
Control	control	The Control group receives standard IV-inhaled general anesthesia.

Primary Outcome Measures

Name	Time	Method
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.
Hemodynamic Parameters: Heart Rate.	up to 48h after surgery	Continuous monitoring of heart rate to 48 hours after surgery.
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 Glucose (Glu)	up to 48h after surgery	When venous blood are collected, glucose levels are measured immediately by Glucometer.
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 Outcome Measures

Name	Time	Method
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.
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.
Anesthetics Consumption: Sufentanil Consumption	during operation	Intraoperative superaddition of sufentanil was measured.
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.
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.
Anesthesia Recovery: the Time of First Flatus	Through study completion, an average of 2 weeks	The time of first flatus was measured after surgery.
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.
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.