Transversus Abdominis Plane Block on Stress Response

NCT ID: NCT03035916

Last Updated: 2018-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 91 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-20
• Study Completion Date: 2017-07-15

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.

Conditions

Gastrostomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Transversus abdominis plane block

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Epidural anesthesia

Intervention Type: 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.

Control

The Control group receives standard IV-inhaled general anesthesia.

Group Type: PLACEBO_COMPARATOR

control

Intervention Type: OTHER

The Control group receives standard IV-inhaled general anesthesia.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

control

The Control group receives standard IV-inhaled general anesthesia.

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jilin University

OTHER

Sponsor Role: lead

Responsible Party

Zhao Guoqing

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Guoqing Zhao, doctor

Role: PRINCIPAL_INVESTIGATOR

Jilin University

Locations

China-Japan Union Hospital of Jilin University

Changchun, Jilin, China

Countries

China

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

3R210Z893430

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

3D5l4L463430

Identifier Type: -

Identifier Source: org_study_id