Gastric Cancer
Conditions
Keywords
gastric cancer, gastrectomy, multimodal analgesia, parecoxib
Brief summary
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
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.
Interventions
PROCEDUREMultimodal analgesia
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.
PROCEDUREPCIA analgesia
PCIA analgesia:patient-controlled intravenous analgesia with tramadol.
Sponsors
Pfizer
JIANG Zhi-Wei
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is a randomized, parallel, controlled, open study.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Requirements of informed consent and assent of participant, parent or legal guardian as applicable. 2. Patients underwent laparoscopic radical gastrectomy under general anesthesia and between the age of 18 and 75 years old without considering sex. 3. American Society of Anesthesiologists (ASA) physical status I-III. 4. Participants can follow the drug doses and visit plan
Exclusion criteria
1. Patients certified by a doctor that doesn't fit to participate in this study. 2. Patients allergic to opioids, sulfas, parecoxib, non-steroidal drugs, acetaminophen, tramadol etc.. 3. 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). 4. Patients with gastric cancer with distant metastasis. 5. Patients with severe infection, respiratory dysfunction, coagulation disorders, severe liver and renal dysfunction (Child - Pugh≥ 10; creatinine clearance \< 25 ml/min). 6. Patients with suspect or have a history of drug abuse. 7. Pregnancy and lactation women, or have a pregnancy plan within a month after the test of the subjects (also including male participants). 8. Sponsors or researchers directly involved in the testing or their family members. 9. Patients with conversion, palliative resection. 10. Patients with chronic pain（NRS≥3）or using opioids or NSAIDs before surgery.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numeric rating scales (NRS) score with 24 hours after the surgery | 1 day | pain evaluation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of remedial treatment | 1 week | pain evaluation |
| Time to first flatus | 1 week | Bowel function recovery |
| Time to first off-bed activity | 1 week | Postoperative activity |
| Time of off-bed activity per day | 1 week | Postoperative activity |
| Length of off-bed activity per day | 1 week | Postoperative activity |
| Time to first semi-liquid diet | 1 week | Bowel function recovery |
| NRS score after 24 hours postoperatively | 1 week | pain evaluation |
| C-reactive protein (CRP) | 1 week | Inflammatory indicators |
| interleukin-6 (IL-6) | 1 week | Inflammatory indicators |
| Albumin | 1 year | Nutritional status |
| Total protein | 1 year | Nutritional status |
| Prealbumin | 1 year | Nutritional status |
| Postoperative length of stay | 1 month | postoperative length of stay |
Countries
China
Contacts
Primary ContactZhi-Wei JIANG, Ph.D.
Backup ContactJian ZHAO, Ph.D.
Outcome results
None listed