Ignite Creation Date:
2025-12-24 @ 2:17 PM
Ignite Modification Date:
2025-12-26 @ 7:06 AM
Study NCT ID:
NCT05825495
Status:
UNKNOWN
Last Update Posted:
2023-04-25
First Post:
2023-04-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Postoperative Pain Management on Uvulopalatopharyngoplasty Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D059787', 'term': 'Acute Pain'}], '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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 78}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2024-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-23', 'studyFirstSubmitDate': '2023-04-11', 'studyFirstSubmitQcDate': '2023-04-11', 'lastUpdatePostDateStruct': {'date': '2023-04-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-23', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain intensity', 'timeFrame': 'within 3 days after surgery', 'description': 'Pain intensity will be assessed via numeric rating scale, 0 means no pain and 10 means the worst pain imaged.'}], 'secondaryOutcomes': [{'measure': 'Pain intensity', 'timeFrame': 'within 14 days after surgery', 'description': 'Pain intensity will be assessed via numeric rating scale, 0 means no pain and 10 means the worst pain imaged.'}, {'measure': 'Consumption of analgesics', 'timeFrame': 'within 3 days after surgery', 'description': 'Consumption of analgesics will be summarized by drug categories, routes and the individual days administrated.'}, {'measure': 'Consumption of analgesics', 'timeFrame': 'within 14 days after surgery', 'description': 'Consumption of analgesics will be summarized by drug categories, routes and the individual days administrated.'}, {'measure': 'Percentage of patients consuming analgesics', 'timeFrame': 'within 3 days after surgery', 'description': 'Percentage and number of patients consuming analgesics will be summarized by drug categories, route and the individual days administrated.'}, {'measure': 'Incidence of adverse events', 'timeFrame': 'within 3 days after surgery', 'description': 'Percentage and number of patients suffering from adverse events will be summarized by the individual days.'}, {'measure': 'Incidence of adverse events', 'timeFrame': 'within 14 days after surgery', 'description': 'Percentage and number of patients suffering from adverse events will be summarized by the individual days.'}, {'measure': 'EAT-10 (Eating Assessment Tool)', 'timeFrame': '1 day, 3 days, 7 days and 14 days after surgery', 'description': 'EAT-10 is a dysphagia assessment that helps to measure swallowing difficulties. There are 10 questions in the questionnaire. Each question has 5 levels, 0 means no problem and 4 means severe problem.'}, {'measure': 'MD Anderson Dysphagia Inventory', 'timeFrame': '1 day, 3 days, 7 days and 14 days after surgery', 'description': 'The MDADI is the first validated and reliable self-administered questionnaire designed specifically for evaluating the impact of dysphagia on the QOL of patients with head and neck cancer. There are 20 questions in the questionnaire. Each question has five levels, including strongly disagree, disagree, no opinion, agree, strongly agree.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['dinalbuphine sebacte', 'nalbuphine', 'Naldebain', 'Uvulopalatopharyngoplasty'], 'conditions': ['Pain, Postoperative', 'Obstructive Sleep Apnea-hypopnea Syndrome', 'Pain, Acute']}, 'descriptionModule': {'briefSummary': 'This is a randomized controlled study, aimed to investigate the effects of dinalbuphine sebacate (DS) on patients having uvulopalatopharyngoplasty (UPPP). DS is a prodrug of nalbuphine, a mixed agonist-antagonist opioid. The mean absorption time for the complete release of DS into systemic circulation is approximately 145 h, which could theoretically provide extended analgesic effects for up to 6 days. Patients diagnosed with obstructive sleep apnea are generally associated with higher risks towards opioid side effects, especially respiratory depression. Post-UPPP pain managing should be cautiously arranged and executed. We hypothesize that the combination of our routine practice and DS will improve the outcomes after Uppp.', 'detailedDescription': 'Within 4 weeks before uvulopalatopharyngoplasty, patients are invited for this study. After written informed consent gained, the eligibilities are checked. Eligible patients are arrogated into experimental or control group randomly prior to surgery. Experimental group receives the DS administration at least 12 hours before surgery. During peri-operative period, pain management are conducted following our routine practice. Pain intensity, consumption of analgesics, adverse events, swallow function and life quality are all assessed and recorded within 14 days after surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* aged between 20 and 65.\n* diagnosed with obstructive sleep apnea.\n* arranged to undergo uvulopalatopharyngoplasty.\n* classified as ASA I, II, or III.\n\nExclusion Criteria:\n\n* can not comply with study protocol.\n* BMI \\> 34 kg/m2.\n* history of chronic pain.\n* history of narcotics or alcohol abuse.\n* allergic to NSAID.\n* diagnosed as diabetes mellitus with poor glycemic control.\n* diagnosed with severe cardiovascular or respiratory diseases.\n* judged as an unsuitable subject by investigators.'}, 'identificationModule': {'nctId': 'NCT05825495', 'briefTitle': 'Postoperative Pain Management on Uvulopalatopharyngoplasty Patients', 'organization': {'class': 'OTHER', 'fullName': 'Chang Gung Memorial Hospital'}, 'officialTitle': 'Postoperative Pain Management on Uvulopalatopharyngoplasty Patients', 'orgStudyIdInfo': {'id': '202202344A3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Experimental group', 'description': 'Subjects will intragluteally injected with a dose of 150 mg dinalbuphine sebacate at least 12 hours before surgery. During intra- and post-operative period, the pain management will execute following our routine practice.', 'interventionNames': ['Drug: Dinalbuphine sebacate', 'Other: Routine practice']}, {'type': 'SHAM_COMPARATOR', 'label': 'Control group', 'description': 'The pain management will peri-operatively execute following our routine practice without dinalbuphine sebacate administration.', 'interventionNames': ['Other: Routine practice']}], 'interventions': [{'name': 'Dinalbuphine sebacate', 'type': 'DRUG', 'otherNames': ['Naldebain'], 'description': 'A single dose of 150 mg dinalbuphine sebacate will be intragluteally administrated at least 12 hours before surgery.', 'armGroupLabels': ['Experimental group']}, {'name': 'Routine practice', 'type': 'OTHER', 'description': 'Within 3 days after surgery, paracoxib will be administrated twice a day. Ketorolac will intravenously give once breakthrough pain occurring. Enteral acetaminophen will be take regularly within 14 days after surgery.', 'armGroupLabels': ['Control group', 'Experimental group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Li-Jen Hsin, MD', 'role': 'CONTACT', 'email': 'lijen.hsin@gmail.com', 'phone': '886-3-3281200', 'phoneExt': '8466'}], 'overallOfficials': [{'name': 'Li-Jen Hsin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Linkou Chang Gung Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Li-Jen Hsin', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Li-Jen Hsin', 'investigatorAffiliation': 'Chang Gung Memorial Hospital'}}}}