Clinical trial NCT03035916: Transversus Abdominis Plane Block on Stress Response
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastrostomy
Keywords: transversus abdominal plane block
epidural anesthesia
stress response
anesthetic recovery
Lead sponsor: Jilin University
Sponsor class: OTHER
First posted: 2017-01-30
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Physiological Parameters: Plasma Concentration of Norepinephrine (NE)
timeFrame: up to 48h after surgery
measure: Physiological Parameters: Plasma Concentration of Epinephrine (E)
timeFrame: up to 48h after surgery
measure: Physiological Parameters: Plasma Concentration of Cortisol (Cor)
timeFrame: up to 48h after surgery
measure: Physiological Parameters: Plasma Concentration of Glucose (Glu)
timeFrame: up to 48h after surgery
measure: Hemodynamic Parameters: Heart Rate.
timeFrame: up to 48h after surgery
measure: Hemodynamic Parameters: Mean Arterial Pressure(MAP)
timeFrame: up to 48h after surgery
Secondary outcomes:
measure: Anesthetics Consumption: Sufentanil Consumption
timeFrame: during operation
measure: Questionnaire: Pain Scores at Rest
timeFrame: 1hr, 6hr, 12hr, 24hr, and 48hr after surgery
measure: Questionnaire: Pain Scores on Movement
timeFrame: 1hr, 6hr, 12hr, 24hr, and 48hr after surgery
measure: Anesthesia Recovery: the Time of First Flatus
timeFrame: Through study completion, an average of 2 weeks
measure: Anesthesia Recovery: Number of Participants With Prolonged Hospitalization
timeFrame: Through study completion, an average of 2 weeks
measure: Side Effects: Number of Participants With Sedation
timeFrame: up to 48h after surgery
measure: Side Effects: Number of Participants With Nausea
timeFrame: up to 48h after surgery
measure: Side Effects: Number of Participants With Vomiting
timeFrame: up to 48h after surgery
Other outcomes:
Locations:
city: Changchun
country: China
facility: China-Japan Union Hospital of Jilin University
state: Jilin
Study officials:
affiliation: Jilin University
name: Guoqing Zhao, doctor
role: PRINCIPAL_INVESTIGATOR
References: