Multimodal Analgesia in Laparoscopic Radical Gastrectomy With Gastric Cancer: a Multi-center Study
NCT ID: NCT03236051
Last Updated: 2017-08-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
156 participants
INTERVENTIONAL
2017-02-10
2018-08-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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multimodal analgesia
Patients received multimodal analgesia after laparoscopic gastrectomy .
Multimodal 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.
PCIA analgesia
Patients received PCIA analgesia after laparoscopic gastrectomy.
PCIA analgesia
PCIA analgesia:patient-controlled intravenous analgesia with tramadol.
Interventions
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Multimodal 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.
PCIA analgesia
PCIA analgesia:patient-controlled intravenous analgesia with tramadol.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
JIANG Zhi-Wei
OTHER
Responsible Party
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JIANG Zhi-Wei
Vice director of Research Institute of General Surgery
Principal Investigators
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Zhi-Wei JIANG, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Jinling Hospital, Medical School of Nanjing University
Jian ZHAO, Ph.D.
Role: STUDY_DIRECTOR
Jinling Hospital, Medical School of Nanjing University
Gang WANG, Ph.D.
Role: STUDY_DIRECTOR
Jinling Hospital, Medical School of Nanjing University
Jiang LIU, M.D.
Role: STUDY_DIRECTOR
Jinling Hospital, Medical School of Nanjing University
Locations
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Jinling Hospital, Medical School of Nanjing University
Nanjing, Jiangsu, China
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2016HR1116
Identifier Type: -
Identifier Source: org_study_id
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