Epidural versus Multi-modal Analgesia for Gastrectomy with Minimally Invasive approach

JRCT ID: jRCT1061220107

Registered date:03/03/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Gastric cancer
• Date of first enrollment: 20/06/2023
• Target sample size: 210
• Study type: Interventional

Intervention(s)

Patients who underwent elective minimally invasive gastrectomy (MIS) for gastric cancer (GC) receive epidural analgesia (EDA) or multimodal analgesia (patient-controlled intravenous analgesia, local anesthesia to the wounds and scheduled intravenous administration of acetaminophen) after surgery.

EDA group
An epidural catheter is inserted at the thoracic level (Th 8-10) before induction of anesthesia. Continuous infusion (2-6 ml/h) or bolus injection of 0.2% ropivacaine or 0.15-0.25% levobupivacaine with fentanyl (0-3.5 ug/mL) is performed until the end of surgery. After surgery, patients are allowed a bolus of 2-3 mL every 15-30 min. EDA is planned to be discontinued on postoperative day (POD) 2 but could be continued until POD 7 if the pain management team judged that prolonged application would be beneficial for the patient.

Multimodal analgesia (MMA) group
During surgery, local anesthesia to the wounds (total 20 ml of 0.375% ropivacaine) is performed by surgeons. At awaking from anesthesia, 1000mg of acetaminophen is administrated intravenously and scheduled intravenous administrations are performed every 6 h until POD2. The patients whose body weight are under 50kg are allowed to be administrated acetaminophen up to the maximum dose of 15mg/kg.
After surgery, intravenous fentanyl (10 ug/mL) was started at 0-2 ml/h. A bolus of 1-3 ml was allowed every 7-30 min, and is planned to be discontinued POD 2, but could be continued until POD 7 if the pain management team judged that prolonged application would be beneficial for the patient.

Outcome(s)

• Primary Outcome: Postoperative pain score at rest 24 h after surgery
• Secondary Outcome: Length of postoperative hospital stay, Postoperative complications, Postoperative pain score at rest on day 2,3,4 after surgery, Additional doses of analgesics, Adverse events related to analgesia, first day of flatus, fully mobilization day, operation room stay time, intraoperative opioid use, intraoperative infusion volume

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 85age old
• Gender: Both

Include criteria

1. The patients with gastric cancer who undergo elective curative laparoscopic or robotic gatrectomy.
2. Patient's age is between 20 and 85 years old.
3. Before participation, patients receive adequate information about the study and provide their written consent.

Exclude criteria

1. The patients whose preoperative performance status more than ASA (American Society of Anesthetists) IV
2. The patients undergoing anticoagulant therapy
3. Medical contraindication for epidural analgesia
4. Abnormal anatomy of the spinal column
5. Neoadjuvant chemotherapy
6. esophageal invasion or other organ invasion
7. Immunodeficiency
8. Palliative surgery
9. Emergency surgery
10. The patients who are allergic to acetaminophen
11. Unsuitable patients for enrollment judged by the investigator

Related Information

• Primary Sponsor: Fujiwara Toshiyoshi