Transversus Abdominis Plane Block on Stress Response

• ClinicalTrials.gov Identifier: NCT03035916
• Recruitment Status: Completed
• First Posted: January 30, 2017
• Results First Posted: December 15, 2017
• Last Update Posted: January 23, 2018
• Sponsor: Jilin University
• Information provided by (Responsible Party): Zhao Guoqing, Jilin University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Gastrostomy	Other: Transversus abdominis plane block; Other: Epidural anesthesia; Other: control	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 91 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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.
• Actual Study Start Date: January 20, 2017
• Actual Primary Completion Date: May 31, 2017
• Actual Study Completion Date: July 15, 2017

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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.
3. 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.
4. 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.
5. Hemodynamic Parameters: Heart Rate. [ Time Frame: up to 48h after surgery ]
   Continuous monitoring of heart rate to 48 hours after surgery.
6. 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 Outcome Measures :

1. Anesthetics Consumption: Sufentanil Consumption [ Time Frame: during operation ]
   Intraoperative superaddition of sufentanil was measured.
2. Questionnaire: Pain Scores at Rest [ Time Frame: 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.
3. Questionnaire: Pain Scores on Movement [ Time Frame: 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.
4. Anesthesia Recovery: the Time of First Flatus [ Time Frame: Through study completion, an average of 2 weeks ]
   The time of first flatus was measured after surgery.
5. Anesthesia Recovery: Number of Participants With Prolonged Hospitalization [ Time Frame: 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.
6. Side Effects: Number of Participants With Sedation [ Time Frame: up to 48h after surgery ]
   The state of sedation was evaluated after surgery during first postoperative 48 hours.
7. Side Effects: Number of Participants With Nausea [ Time Frame: up to 48h after surgery ]
   The state of nausea was evaluated after surgery during first postoperative 48 hours.
8. Side Effects: Number of Participants With Vomiting [ Time Frame: up to 48h after surgery ]
   The state of vomiting was evaluated after surgery during first postoperative 48 hours.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

China, Jilin

China-Japan Union Hospital of Jilin University

Changchun, Jilin, China, 130000

Sponsors and Collaborators

Jilin University

Investigators

• Principal Investigator: Guoqing Zhao, doctor; Jilin University

  Study Documents (Full-Text)

Documents provided by Zhao Guoqing, Jilin University:

Study Protocol  [PDF] January 30, 2017

Statistical Analysis Plan  [PDF] January 30, 2017

Informed Consent Form  [PDF] January 30, 2017

More Information

• Responsible Party: Zhao Guoqing, Clinical Professor, Jilin University
• ClinicalTrials.gov Identifier: NCT03035916
• Other Study ID Numbers: 3D5l4L463430; 3R210Z893430 ( Other Grant/Funding Number: Jilin Provincial Department of Science and Technology )
• First Posted: January 30, 2017
• Results First Posted: December 15, 2017
• Last Update Posted: January 23, 2018
• Last Verified: December 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Zhao Guoqing, Jilin University:

transversus abdominal plane block; epidural anesthesia; stress response; anesthetic recovery

Additional relevant MeSH terms:

Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs