Transversus Abdominis Plane Block on Stress Response

NCT03035916 | Completed Results

• 2 other identifiers: 3D5l4L4634303R210Z893430
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastrostomy

Keywords

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

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (8)

• Anesthetics Consumption: Sufentanil Consumption

  during operation

• Questionnaire: Pain Scores at Rest

  1hr, 6hr, 12hr, 24hr, and 48hr after surgery

• Questionnaire: Pain Scores on Movement

  1hr, 6hr, 12hr, 24hr, and 48hr after surgery

• Anesthesia Recovery: the Time of First Flatus

  Through study completion, an average of 2 weeks

• Anesthesia Recovery: Number of Participants With Prolonged Hospitalization

  Through study completion, an average of 2 weeks

Study Arms (3)

Transversus abdominis plane block

EXPERIMENTAL

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

Epidural anesthesia

ACTIVE COMPARATOR

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

Control

PLACEBO COMPARATOR

The Control group receives standard IV-inhaled general anesthesia.

Other: control

Interventions

Transversus abdominis plane block OTHER

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.

Transversus abdominis plane block

Epidural anesthesia OTHER

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.

Epidural anesthesia

control OTHER

The Control group receives standard IV-inhaled general anesthesia.

Control

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Consent
• ASA 1-3
• No contraindication to epidural or ropivacaine
• First time surgery for current conditions
• Not on chronic pain medications or sedative

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jilin University: lead

Study Sites (1)

China-Japan Union Hospital of Jilin University

Changchun, Jilin, 130000, China

Location

MeSH Terms

Conditions

Fractures, Stress

Interventions

Anesthesia, Epidural

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Limitations and Caveats

Firstly, early termination leading to small numbers of subjects analyzed. Secondly, sufentanil for analgesia, known to have effects on neuroimmunoendocrine network, which may have influenced our finding.

Results Point of Contact

• Title: Dr. Guoqing Zhao
• Organization: China-Japan Unit Hospital of Jilin University

zhaogq65@126.com

0435-84995117

Study Officials

• Guoqing Zhao, doctor

  Jilin University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: January 13, 2017
• First Posted: January 30, 2017
• Study Start: January 20, 2017
• Primary Completion: May 31, 2017
• Study Completion: July 15, 2017
• Last Updated: January 23, 2018
• Results First Posted: December 15, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)