Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2026-01-03 @ 2:17 PM
Study NCT ID:
NCT03236051
Status:
UNKNOWN
Last Update Posted:
2017-08-01
First Post:
2017-07-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multimodal Analgesia in Laparoscopic Radical Gastrectomy With Gastric Cancer: a Multi-center Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013274', 'term': 'Stomach Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a randomized, parallel, controlled, open study.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 156}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-02-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2018-08-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-07-27', 'studyFirstSubmitDate': '2017-07-26', 'studyFirstSubmitQcDate': '2017-07-27', 'lastUpdatePostDateStruct': {'date': '2017-08-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Numeric rating scales (NRS) score with 24 hours after the surgery', 'timeFrame': '1 day', 'description': 'pain evaluation'}], 'secondaryOutcomes': [{'measure': 'NRS score after 24 hours postoperatively', 'timeFrame': '1 week', 'description': 'pain evaluation'}, {'measure': 'Number of remedial treatment', 'timeFrame': '1 week', 'description': 'pain evaluation'}, {'measure': 'Time to first flatus', 'timeFrame': '1 week', 'description': 'Bowel function recovery'}, {'measure': 'Time to first off-bed activity', 'timeFrame': '1 week', 'description': 'Postoperative activity'}, {'measure': 'Time of off-bed activity per day', 'timeFrame': '1 week', 'description': 'Postoperative activity'}, {'measure': 'Length of off-bed activity per day', 'timeFrame': '1 week', 'description': 'Postoperative activity'}, {'measure': 'Time to first semi-liquid diet', 'timeFrame': '1 week', 'description': 'Bowel function recovery'}, {'measure': 'Postoperative length of stay', 'timeFrame': '1 month', 'description': 'postoperative length of stay'}, {'measure': 'C-reactive protein (CRP)', 'timeFrame': '1 week', 'description': 'Inflammatory indicators'}, {'measure': 'interleukin-6 (IL-6)', 'timeFrame': '1 week', 'description': 'Inflammatory indicators'}, {'measure': 'Albumin', 'timeFrame': '1 year', 'description': 'Nutritional status'}, {'measure': 'Total protein', 'timeFrame': '1 year', 'description': 'Nutritional status'}, {'measure': 'Prealbumin', 'timeFrame': '1 year', 'description': 'Nutritional status'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['gastric cancer', 'gastrectomy', 'multimodal analgesia', 'parecoxib'], 'conditions': ['Gastric Cancer']}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Requirements of informed consent and assent of participant, parent or legal guardian as applicable.\n2. Patients underwent laparoscopic radical gastrectomy under general anesthesia and between the age of 18 and 75 years old without considering sex.\n3. American Society of Anesthesiologists (ASA) physical status I-III.\n4. Participants can follow the drug doses and visit plan\n\nExclusion Criteria:\n\n1. Patients certified by a doctor that doesn't fit to participate in this study.\n2. Patients allergic to opioids, sulfas, parecoxib, non-steroidal drugs, acetaminophen, tramadol etc..\n3. 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).\n4. Patients with gastric cancer with distant metastasis.\n5. Patients with severe infection, respiratory dysfunction, coagulation disorders, severe liver and renal dysfunction (Child - Pugh≥ 10; creatinine clearance \\< 25 ml/min).\n6. Patients with suspect or have a history of drug abuse.\n7. Pregnancy and lactation women, or have a pregnancy plan within a month after the test of the subjects (also including male participants).\n8. Sponsors or researchers directly involved in the testing or their family members.\n9. Patients with conversion, palliative resection.\n10. Patients with chronic pain（NRS≥3）or using opioids or NSAIDs before surgery."}, 'identificationModule': {'nctId': 'NCT03236051', 'briefTitle': 'Multimodal Analgesia in Laparoscopic Radical Gastrectomy With Gastric Cancer: a Multi-center Study', 'organization': {'class': 'OTHER', 'fullName': 'Jinling Hospital, China'}, 'officialTitle': 'Multimodal Analgesia in Laparoscopic Radical Gastrectomy With Gastric Cancer: a Multi-center Study', 'orgStudyIdInfo': {'id': '2016HR1116'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'multimodal analgesia', 'description': 'Patients received multimodal analgesia after laparoscopic gastrectomy .', 'interventionNames': ['Procedure: Multimodal analgesia']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PCIA analgesia', 'description': 'Patients received PCIA analgesia after laparoscopic gastrectomy.', 'interventionNames': ['Procedure: PCIA analgesia']}], 'interventions': [{'name': 'Multimodal analgesia', 'type': 'PROCEDURE', 'description': "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.", 'armGroupLabels': ['multimodal analgesia']}, {'name': 'PCIA analgesia', 'type': 'PROCEDURE', 'description': 'PCIA analgesia:patient-controlled intravenous analgesia with tramadol.', 'armGroupLabels': ['PCIA analgesia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210002', 'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhi-Wei JIANG, Ph.D.', 'role': 'CONTACT', 'email': 'surgery34@163.com', 'phone': '8602580860034'}, {'name': 'Jian ZHAO, Ph.D.', 'role': 'CONTACT', 'email': 'zhaojiangogo@163.com', 'phone': '8602580860034'}, {'name': 'Zhi-Wei JIANG, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Jian ZHAO, Ph.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Gang WANG, Ph.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jiang LIU, M.D.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Jinling Hospital, Medical School of Nanjing University', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'zip': '210011', 'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qinghong ZHAO, Ph.D.', 'role': 'CONTACT', 'email': 'njzhqh@sina.com'}, {'name': 'Baolin WANG, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Qinghong ZHAO, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The Second Affiliated Hospital of Nanjing Medical University', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'centralContacts': [{'name': 'Zhi-Wei JIANG, Ph.D.', 'role': 'CONTACT', 'email': 'surgery34@163.com', 'phone': '8602580860034'}, {'name': 'Jian ZHAO, Ph.D.', 'role': 'CONTACT', 'email': 'zhaojiangogo@163.com', 'phone': '8602580860034'}], 'overallOfficials': [{'name': 'Zhi-Wei JIANG, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jinling Hospital, Medical School of Nanjing University'}, {'name': 'Jian ZHAO, Ph.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Jinling Hospital, Medical School of Nanjing University'}, {'name': 'Gang WANG, Ph.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Jinling Hospital, Medical School of Nanjing University'}, {'name': 'Jiang LIU, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Jinling Hospital, Medical School of Nanjing University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'JIANG Zhi-Wei', 'class': 'OTHER'}, 'collaborators': [{'name': 'Pfizer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Vice director of Research Institute of General Surgery', 'investigatorFullName': 'JIANG Zhi-Wei', 'investigatorAffiliation': 'Jinling Hospital, China'}}}}