Transversus Abdominis Plane Block on Stress Response

Gastrostomy Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03035916
• Other study ID #: 3D5l4L463430
• Secondary ID: 3R210Z893430
• Status: Completed
• Phase: N/A
• First received: January 13, 2017
• Last updated: December 20, 2017
• Start date: January 20, 2017
• Est. completion date: July 15, 2017

Study information

• Verified date: December 2017
• Source: Jilin University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: July 15, 2017
• Est. primary completion date: May 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

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.

Related Conditions & MeSH terms

• Gastrostomy

Intervention

Other:
• 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.
• 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.
• control
The Control group receives standard IV-inhaled general anesthesia.

Locations

Country	Name	City	State
China	China-Japan Union Hospital of Jilin University	Changchun	Jilin

Sponsors (1)

Lead Sponsor	Collaborator
Jilin University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	up to 48h after surgery
Primary	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.	up to 48h after surgery
Primary	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.	up to 48h after surgery
Primary	Physiological Parameters: Plasma Concentration of Glucose (Glu)	When venous blood are collected, glucose levels are measured immediately by Glucometer.	up to 48h after surgery
Primary	Hemodynamic Parameters: Heart Rate.	Continuous monitoring of heart rate to 48 hours after surgery.	up to 48h after surgery
Primary	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	up to 48h after surgery
Secondary	Anesthetics Consumption: Sufentanil Consumption	Intraoperative superaddition of sufentanil was measured.	during operation
Secondary	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.	1hr, 6hr, 12hr, 24hr, and 48hr after surgery
Secondary	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.	1hr, 6hr, 12hr, 24hr, and 48hr after surgery
Secondary	Anesthesia Recovery: the Time of First Flatus	The time of first flatus was measured after surgery.	Through study completion, an average of 2 weeks
Secondary	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.	Through study completion, an average of 2 weeks
Secondary	Side Effects: Number of Participants With Sedation	The state of sedation was evaluated after surgery during first postoperative 48 hours.	up to 48h after surgery
Secondary	Side Effects: Number of Participants With Nausea	The state of nausea was evaluated after surgery during first postoperative 48 hours.	up to 48h after surgery
Secondary	Side Effects: Number of Participants With Vomiting	The state of vomiting was evaluated after surgery during first postoperative 48 hours.	up to 48h after surgery