Multimodal Analgesia in Laparoscopic Radical Gastrectomy With Gastric Cancer: a Multi-center Study

Study Overview
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Brief Summary
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The study is aimed to explore the effects of multimodal analgesia consisting of ropivacaine's wound infiltration, parecoxib's intravenous injection and oxycodone-acetaminophen tablets' oral administration on postoperative pain and rehabilitation after laparoscopic radical gastrectomy for patients with gastric cancer.

Detailed Description
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Postoperative pain attracts the attention of surgeons, and optimal postoperative pain management contributes to reducing complications and accelerating postoperative rehabilitation. Traditionally, the opioids were used for postoperative pain control. However, the opioids may increase the time to recover bowel function and lead to postoperative ileus. Multimodal analgesia is recommended in recent years, but studies on multimodal analgesia after gastrectomy are scarce. In this study, we introduced a multimodal analgesia strategy consisting of incision infiltration with ropivacaine, intravenous injection of parecoxib, and oral administration of an oxycodone/paracetamol mixture and evaluated the effects of this strategy compared with PCIA analgesia which is used widely for pain after gastrectomy.

Official Title
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Multimodal Analgesia in Laparoscopic Radical Gastrectomy With Gastric Cancer: a Multi-center Study

Conditions
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Gastric Cancer

Intervention / Treatment
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* Procedure: Multimodal analgesia
* Procedure: PCIA analgesia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Requirements of informed consent and assent of participant, parent or legal guardian as applicable. Patients underwent laparoscopic radical gastrectomy under general anesthesia and between the age of 18 and 75 years old without considering sex. American Society of Anesthesiologists (ASA) physical status I-III. Participants can follow the drug doses and visit plan Exclusion Criteria: Patients certified by a doctor that doesn't fit to participate in this study. Patients allergic to opioids, sulfas, parecoxib, non-steroidal drugs, acetaminophen, tramadol etc.. Patients with ischemic heart disease, cerebrovascular disease and peripheral vascular disease, or their cardiac function > II (NYHA) patients, patients received coronary artery bypass grafting (CABG) recently, and patients with severe hypertension (systolic pressure≥180mmHg or diastolic pressure≥110mmHg). Patients with gastric cancer with distant metastasis. Patients with severe infection, respiratory dysfunction, coagulation disorders, severe liver and renal dysfunction (Child - Pugh≥ 10; creatinine clearance < 25 ml/min). Patients with suspect or have a history of drug abuse. Pregnancy and lactation women, or have a pregnancy plan within a month after the test of the subjects (also including male participants). Sponsors or researchers directly involved in the testing or their family members. Patients with conversion, palliative resection. Patients with chronic pain（NRS≥3）or using opioids or NSAIDs before surgery.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a randomized, parallel, controlled, open study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: multimodal analgesia<br>Patients received multimodal analgesia after laparoscopic gastrectomy . | Procedure: Multimodal analgesia<br>* Multimodal analgesia is the name of a procedure or program. Multimodal analgesia doesn't mean different interventions are used. Patients in this group need receive this analgesia program (procedure) instead of one analgesic drug or technology. The program consists of incision infiltration with ropivacaine, intravenous injection of parecoxib, and oral administration of oxycodone/paracetamol mixture.<br>|
| Active Comparator: PCIA analgesia<br>Patients received PCIA analgesia after laparoscopic gastrectomy. | Procedure: PCIA analgesia<br>* PCIA analgesia:patient-controlled intravenous analgesia with tramadol.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numeric rating scales (NRS) score with 24 hours after the surgery | pain evaluation | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NRS score after 24 hours postoperatively | pain evaluation | 1 week | 
| Number of remedial treatment | pain evaluation | 1 week | 
| Time to first flatus | Bowel function recovery | 1 week | 
| Time to first off-bed activity | Postoperative activity | 1 week | 
| Time of off-bed activity per day | Postoperative activity | 1 week | 
| Length of off-bed activity per day | Postoperative activity | 1 week | 
| Time to first semi-liquid diet | Bowel function recovery | 1 week | 
| Postoperative length of stay | postoperative length of stay | 1 month | 
| C-reactive protein (CRP) | Inflammatory indicators | 1 week | 
| interleukin-6 (IL-6) | Inflammatory indicators | 1 week | 
| Albumin | Nutritional status | 1 year | 
| Total protein | Nutritional status | 1 year | 
| Prealbumin | Nutritional status | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gastric cancer, gastrectomy, multimodal analgesia, parecoxib