Transversus Abdominis Plane Block on Stress Response

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.

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.

Study Overview

• Status: Completed
• Conditions: Gastrostomy
• Intervention / Treatment: Other: Transversus abdominis plane block; Other: Epidural anesthesia; Other: control

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.

• Study Type: Interventional
• Enrollment (Actual): 91
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jilin
    • Changchun, Jilin, China, 130000
      • China-Japan Union Hospital of Jilin University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	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.
ACTIVE_COMPARATOR: 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.	Other: 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.
PLACEBO_COMPARATOR: Control; The Control group receives standard IV-inhaled general anesthesia.	Other: control; The Control group receives standard IV-inhaled general anesthesia.

What is the study measuring?

Primary Outcome Measures

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

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

Collaborators and Investigators

• Sponsor: Jilin University
• Investigators: Principal Investigator: Guoqing Zhao, doctor, Jilin University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 20, 2017
• Primary Completion (ACTUAL): May 31, 2017
• Study Completion (ACTUAL): July 15, 2017

Study Registration Dates

• First Submitted: January 13, 2017
• First Submitted That Met QC Criteria: January 26, 2017
• First Posted (ESTIMATE): January 30, 2017

Study Record Updates

• Last Update Posted (ACTUAL): January 23, 2018
• Last Update Submitted That Met QC Criteria: December 20, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: stress response; epidural anesthesia; transversus abdominal plane block; anesthetic recovery
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: 3D5l4L463430; 3R210Z893430 (OTHER_GRANT: Jilin Provincial Department of Science and Technology)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No