Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2026-03-01 @ 12:06 PM
Study NCT ID:
NCT02240602
Status:
WITHDRAWN
Last Update Posted:
2015-06-16
First Post:
2014-09-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimal Dose of i.v Oxycodone for Postoperative Pain After Laparoscopic Colorectal Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D059787', 'term': 'Acute Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010098', 'term': 'Oxycodone'}], 'ancestors': [{'id': 'D003061', 'term': 'Codeine'}, {'id': 'D009022', 'term': 'Morphine Derivatives'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Lack of internal resources', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2015-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-06-14', 'studyFirstSubmitDate': '2014-09-11', 'studyFirstSubmitQcDate': '2014-09-11', 'lastUpdatePostDateStruct': {'date': '2015-06-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-09-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'sedation', 'timeFrame': '24 hr after surgery', 'description': 'sedation with Ramsay sedation score (1-6) at 24 hr after surgery'}], 'primaryOutcomes': [{'measure': 'resting postoperative pain at 24hr', 'timeFrame': '24 hr after surgery', 'description': 'Primary outcome is resting postoperative pain at 24 hr after surgery with numeric rating scale 0-10.'}], 'secondaryOutcomes': [{'measure': 'side effects', 'timeFrame': '24 hr after surgery', 'description': 'Secondary outcome includes any side effect at 24 hr after surgery.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['acute pain', 'postoperative', 'surgery'], 'conditions': ['Pain']}, 'descriptionModule': {'briefSummary': 'Postoperative pain control is required after major abdominal surgery, including laparoscopic colorectal surgery. Intravenous oxycodone is widely used for postoperative acute pain control mainly in Europe. The aim of this study is to evaluate the optimal dose of intravenous oxycodone for pain control after laparoscopic colorectal surgery in Korean.', 'detailedDescription': 'Oxycodone is known to be effective in pain control and has less sedative effect than morphine does. It has been described that distribution of cytochrome P450, which is associated with metabolism of oxycodone, differed between the races. Proper dose of intravenous oxycodone after major abdominal surgery has not been well defined in Korean. The purpose of this study is to evaluate the optimal dose of intravenous oxycodone for pain control after laparoscopic colorectal surgery in Korean based on pain score and side effects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American Society of Anesthesiologists class 1,2\n* Expected surgical time between 2 - 6 hours\n* Scheduled for laparoscopic colorectal surgery\n\nExclusion Criteria:\n\n* Severe dysfunction of liver, heart, kidney, or lung\n* Cannot understand numeric rating scale of pain\n* Known or suspected allergy to oxycodone\n* Previous history of postoperative nausea or vomiting\n* Medication of antidepressants\n* Postoperative long-term ICU care or prolonged mechanical ventilatory support\n* Chronic pain\n* Drug abuser\n* Hypersensitivity reaction to aspirin or NSAIDs\n* Refuse to enroll'}, 'identificationModule': {'nctId': 'NCT02240602', 'briefTitle': 'Optimal Dose of i.v Oxycodone for Postoperative Pain After Laparoscopic Colorectal Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Optimal Dose of i.v Oxycodone for Postoperative Pain After Laparoscopic Colorectal Surgery', 'orgStudyIdInfo': {'id': 'OxyNorm'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Oxycodone, 1.00 mg dose', 'description': 'Regimen of intravenous patient-controlled analgesia consists of bolus dose of oxycodone 1.00 mg with lock out time of 10 min without basal infusion.', 'interventionNames': ['Drug: Oxycodone, 1.00 mg dose']}, {'type': 'EXPERIMENTAL', 'label': 'Oxycodone, 0.03 mg/kg dose', 'description': 'Regimen of intravenous patient-controlled analgesia consists of bolus dose of oxycodone 0.03 mg/kg with lock out time of 10 min without basal infusion.', 'interventionNames': ['Drug: Oxycodone, 0.03 mg/kg dose']}, {'type': 'EXPERIMENTAL', 'label': 'Oxycodone, 0.02 mg/kg dose', 'description': 'Regimen of intravenous patient-controlled analgesia consists of bolus dose of oxycodone 0.02 mg/kg with lock out time of 10 min without basal infusion.', 'interventionNames': ['Drug: Oxycodone, 0.02 mg/kg dose']}], 'interventions': [{'name': 'Oxycodone, 1.00 mg dose', 'type': 'DRUG', 'otherNames': ['OxyNorm'], 'description': 'Intravenous oxycodone is provided as patient-controlled analgesia after surgery with bolus dose of 1.00 mg.', 'armGroupLabels': ['Oxycodone, 1.00 mg dose']}, {'name': 'Oxycodone, 0.03 mg/kg dose', 'type': 'DRUG', 'otherNames': ['OxyNorm'], 'description': 'Intravenous oxycodone is provided as patient-controlled analgesia after surgery with bolus dose of 0.03 mg/kg.', 'armGroupLabels': ['Oxycodone, 0.03 mg/kg dose']}, {'name': 'Oxycodone, 0.02 mg/kg dose', 'type': 'DRUG', 'otherNames': ['OxyNorm'], 'description': 'intravenous oxycodone is provided as patient-controlled analgesia after surgery with bolus dose of 0.02 mg/kg.', 'armGroupLabels': ['Oxycodone, 0.02 mg/kg dose']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110-744', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Yunseok Jeon, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}