Transversus Abdominis Plane Block on Stress Response

Jilin University

Status: Completed

Conditions: Gastrostomy

Treatments: Other: control; Other: Transversus abdominis plane block; Other: Epidural anesthesia

Study type: Interventional

Funder types: Other

Identifiers

NCT03035916

3D5l4L463430

3R210Z893430 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 91 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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91 participants in 3 patient groups, including a placebo group

Transversus abdominis plane block

Experimental group

Description:

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.

Treatment:

Other: Transversus abdominis plane block

Epidural anesthesia

Active Comparator group

Description:

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.

Treatment:

Other: Epidural anesthesia

Control

Placebo Comparator group

Description:

The Control group receives standard IV-inhaled general anesthesia.

Treatment:

Other: control