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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| multimodal analgesia | Experimental | Patients received multimodal analgesia after laparoscopic gastrectomy . |
|
| PCIA analgesia | Active Comparator | Patients received PCIA analgesia after laparoscopic gastrectomy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multimodal analgesia | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Numeric rating scales (NRS) score with 24 hours after the surgery | pain evaluation | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| NRS score after 24 hours postoperatively | pain evaluation | 1 week |
| Number of remedial treatment | pain evaluation | 1 week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhi-Wei JIANG, Ph.D. | Contact | 8602580860034 | surgery34@163.com | |
| Jian ZHAO, Ph.D. | Contact | 8602580860034 | zhaojiangogo@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhi-Wei JIANG, Ph.D. | Jinling Hospital, Medical School of Nanjing University | Principal Investigator |
| Jian ZHAO, Ph.D. | Jinling Hospital, Medical School of Nanjing University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jinling Hospital, Medical School of Nanjing University | Recruiting | Nanjing | Jiangsu | 210002 | China |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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This is a randomized, parallel, controlled, open study.
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| PCIA analgesia | Procedure | PCIA analgesia:patient-controlled intravenous analgesia with tramadol. |
|
| 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 |
| Gang WANG, Ph.D. | Jinling Hospital, Medical School of Nanjing University | Study Director |
| Jiang LIU, M.D. | Jinling Hospital, Medical School of Nanjing University | Study Director |
| The Second Affiliated Hospital of Nanjing Medical University | Not yet recruiting | Nanjing | Jiangsu | 210011 | China |
|
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |