Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2025-12-25 @ 9:28 PM
Study NCT ID:
NCT03854851
Status:
UNKNOWN
Last Update Posted:
2019-02-26
First Post:
2019-02-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
NALDEBAIN for Postoperative Pain Management in Take Down of Anastomosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2019-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-02-25', 'studyFirstSubmitDate': '2019-02-20', 'studyFirstSubmitQcDate': '2019-02-25', 'lastUpdatePostDateStruct': {'date': '2019-02-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Time of first farting', 'timeFrame': 'From post-OP to Day 7', 'description': 'Observing when patients are able to pass gas after surgery'}, {'measure': 'Date of discharge', 'timeFrame': 'From post-OP to Day 7', 'description': 'Observing when the condition of patients is good enough to discharge'}], 'primaryOutcomes': [{'measure': 'Supplemental analgesics', 'timeFrame': 'From Day 0 to Day 7', 'description': 'The consumption of total amount (mg) of supplemental analgesics administered after surgery.'}], 'secondaryOutcomes': [{'measure': 'Pain assessment: VAS', 'timeFrame': '2 hours after surgery', 'description': 'Using visual analog scale (VAS) with grades from 0 (no pain) to 10 (worst pain)'}, {'measure': 'Pain assessment: VAS', 'timeFrame': '6 hours after surgery', 'description': 'Using visual analog scale (VAS) with grades from 0 (no pain) to 10 (worst pain)'}, {'measure': 'Pain assessment: VAS', 'timeFrame': '24 hours after surgery', 'description': 'Using visual analog scale (VAS) with grades from 0 (no pain) to 10 (worst pain)'}, {'measure': 'Pain assessment: VAS', 'timeFrame': 'From Day 2 to Day 7', 'description': 'Using visual analog scale (VAS) with grades from 0 (no pain) to 10 (worst pain), once daily'}, {'measure': 'Pain assessment: area under the curve of VAS', 'timeFrame': 'From post-OP to Day 7', 'description': 'Pain assessment (time-specific pain intensity) calculated as the area under the curve of VAS pain intensity scores through 7 days after surgery'}, {'measure': 'Patient satisfaction: frequency of each option', 'timeFrame': 'Day 7', 'description': 'Calculating the frequency of each option: highly satisfied, satisfied, uncertain, dissatisfied and very dissatisfied'}, {'measure': 'frequency of adverse event', 'timeFrame': 'From Day-1 to Day 7', 'description': 'Recording the frequency of treatment-emergent adverse event (TEAE)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Naldebain', 'long-term analgesia', 'take down of anastomosis'], 'conditions': ['Postoperative Pain']}, 'descriptionModule': {'briefSummary': 'NALDEBAIN ER injection, invented by Taiwanese, launched in 2017, is a nalbuphine synthetic prodrug with oil-based solution to extend the release in human body by intramuscular injection. It was approved for the premedication use for moderate to severe pain relief, expected after surgery. There was limited experience with the combination of medication and different type of surgeries. Only the effect of operative analgesia on the hemorrhoidectomy patients have been well studied. Through reviewing the past medical cases, the pain intensity after receiving take down of anastomosis was about 4 to 7 points (moderate pain), lasing about 1 to 3 days. It was a suitable population with multi-day analgesic unmet need.\n\nAt present, the standard treatment after take down of anastomosis in the CMUH was morphine as needed. This treatment might not provide for well-controlled postoperative pain management. Patients might receive more painkillers when they needed than before pain occurred. Plus, it also cost more postoperative medical care. Therefore, this study intended to compare the standard treatment and NALDEBAIN for postoperative outcomes, safety and satisfaction.\n\nThe study will enroll patients scheduled to electively undergo take down of anastomosis. Eligible subjects were randomly divided into two groups, one receiving NALDEBAIN and the other receiving standard treatment. The study will evaluate pain intensity, dosage of supplement analgesics, incidence of adverse reactions, patient satisfaction, time of the first fart after surgery, and duration of postoperative hospital stay.', 'detailedDescription': "This is an open-labeled, randomized clinical trial. After ICFs are signed, patients' medical history will be gained for checking if they are eligible for this study or not. And then, on Day -1, eligible ones will randomly be divide into two separate group: NALDEBAIN or MORPHINE. Group NALDEBAIN will receive Nadebain by gluteus maximus injection between 12 and 24 hours prior to surgery for postoperative pain relief. Group MORPHINE will receive morphine as needed after surgery. All necessary data will be gain form EMR or patient dairies."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Men and Women between 20 and 80 years of age\n2. History of laparoscopic surgery\n3. American Society of Anesthesiology Physical Class 1-3\n4. Ability and willingness to provide informed consent\n\nExclusion Criteria:\n\n1. History of hypersensitivity or allergy to opioid, NSAIDs, or Acetaminophen\n2. Chronic preoperative opioid use\n3. Severe comorbidity which is able to interfere pain assessment\n4. Ostomy surgery of intestine within the past 8 weeks\n5. Pregnant or breastfeeding'}, 'identificationModule': {'nctId': 'NCT03854851', 'briefTitle': 'NALDEBAIN for Postoperative Pain Management in Take Down of Anastomosis', 'organization': {'class': 'OTHER', 'fullName': 'China Medical University Hospital'}, 'officialTitle': 'NALDEBAIN for Postoperative Pain Management in Take Down of Anastomosis', 'orgStudyIdInfo': {'id': 'CMUH107-REC2-110'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NALDEBAIN', 'description': 'In group NALDEBAIN, subjects will receive single dose of Naldebain (150 mg/2 ml) by gluteus maximus injection between 12 and 24 hours prior to surgery.', 'interventionNames': ['Drug: Naldebain']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'MORPHINE', 'description': 'In group MORPHINE, subjects will receive morphine as needed after surgery.', 'interventionNames': ['Drug: Morpine']}], 'interventions': [{'name': 'Naldebain', 'type': 'DRUG', 'description': 'In Naldebain group, patients will be injected with Naldebain (150 mg/2 ml, IM injection) between 12 and 24 hours prior to surgery.', 'armGroupLabels': ['NALDEBAIN']}, {'name': 'Morpine', 'type': 'DRUG', 'description': 'In Morphine group, patients will receive morphine as needed after surgery.', 'armGroupLabels': ['MORPHINE']}]}, 'contactsLocationsModule': {'locations': [{'zip': '404', 'city': 'Taichung', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Hung-Chang Chen', 'role': 'CONTACT', 'email': 'D96591@mail.cmuh.org.tw', 'phone': '04-22052121', 'phoneExt': '81-221071'}, {'name': 'Hung-Chang Chen', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Tzu-Liang Chen', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Hwei-Ming Wang', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Tao-Wei Ke', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Hua-Che Chiang', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Sheng-Chi Chang', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Yu-Chuen Huang', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Yi-Chang Chen', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ming-Hao Hsieh', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Yuan-Yao Tsai', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'China Medical University & Hospital', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}], 'centralContacts': [{'name': 'Hung-Chang Chen', 'role': 'CONTACT', 'email': 'D96591@mail.cmuh.org.tw', 'phone': '04-22052121', 'phoneExt': '81-221071'}], 'overallOfficials': [{'name': 'Hung-Chang Chen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'China Medical University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'China Medical University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Minimally Invasive Centre', 'investigatorFullName': 'Hung-Chang Chen', 'investigatorAffiliation': 'China Medical University Hospital'}}}}