Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2026-03-26 @ 7:49 PM
Study NCT ID:
NCT02804633
Status:
COMPLETED
Last Update Posted:
2016-06-17
First Post:
2016-06-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Decrease Opioid Consumption With Intra-Venous (IV) Acetaminophen After Colorectal Surgery (DOCIVA)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000082', 'term': 'Acetaminophen'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 105}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-14', 'studyFirstSubmitDate': '2016-06-08', 'studyFirstSubmitQcDate': '2016-06-14', 'lastUpdatePostDateStruct': {'date': '2016-06-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-06-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total opioid consumption', 'timeFrame': '48 hours'}, {'measure': 'pain control base on pain visual Analogue Scale Score (1-10)', 'timeFrame': '48 hours'}], 'secondaryOutcomes': [{'measure': 'time to Return of GI function (ROGIF) [Flatus or bowel movement]', 'timeFrame': 'through study completion, an average of 5 days'}, {'measure': 'Time to diet ordered (TTDO)', 'timeFrame': 'through study completion, an average of 5 days'}, {'measure': 'Length of hospital stay (LOHS)', 'timeFrame': 'through study completion, an average of 5 days'}, {'measure': 'Occurrence of ileus', 'timeFrame': 'through study completion, an average of 5 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['IV acetaminophen', 'Colorectal Surgery', 'Enhance Recovery', 'Opioid Consumption', 'Pain Management'], 'conditions': ['Pain Control Post Colorectal Surgery']}, 'descriptionModule': {'briefSummary': 'The investigators hypothesis is that use of IV acetaminophen will significantly decrease use of post-operative opioid consumption and enhances recovery after colorectal surgery.', 'detailedDescription': "All patients undergoing laparoscopic and open colorectal surgery are randomized to receive either IV acetaminophen or placebo. All patients received an opioid patient controlled anesthesia (PCA). IV acetaminophen (1 gram) or placebo is given 30 minutes prior to operation and every 6 hours thereafter for up to 5 days post-operatively or discharge.\n\nThe investigators primary endpoint is to evaluate opioid consumption during the patient's hospital stay. The investigators secondary endpoints are to evaluate return of gastrointestinal function (ROGIF), time to diet ordered (TTDO), length of hospital stay (LOHS) and occurrence of ileus. Pain is measured with the pain visual analog scale score (PVASS) at 3, 8, 24 and 48 hours."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient undergoing colorectal operation (Hartmann's procedure, sigmoidectomy, left hemicolectomy, right hemicolectomy, transverse colectomy, ileocecectomy, colo-colonic anastomosis, colorectal anastomosis, ileo-colonic anastomosis, low anterior resection, or abdominoperineal resection)\n* Age range from 18 to 90 years old\n* Patient providing signed, written informed consent before participation in the study\n\nExclusion Criteria:\n\n* Patient younger than 18 years old or older than 90 years old\n* Patient or family is unable to give consent\n* Patient who use opioids or tramadol daily for \\>7 days before study medication administration(patient who, in the investigator's opinion, had or was developing opioid tolerance)\n* Patient who had a chronic pain condition or any significant medical disease, laboratory abnormality, or condition that, in the investigator's judgment, could have compromised the subject's welfare, ability to communicate with the study staff, complete study activities, or otherwise restricted study participation\n* Patient who had hypersensitivity to opioids, acetaminophen, or the inactive ingredients of the study medication\n* Patient who had known or suspected history of alcohol or drug abuse or dependence within the previous 1 year\n* Patient who had impaired liver function\n* Patient who had fever within first 48 hours post-operatively and required acetaminophen for fever reduction"}, 'identificationModule': {'nctId': 'NCT02804633', 'acronym': 'DOCIVA', 'briefTitle': 'Decrease Opioid Consumption With Intra-Venous (IV) Acetaminophen After Colorectal Surgery (DOCIVA)', 'organization': {'class': 'OTHER', 'fullName': 'Jewish Hospital, Cincinnati, Ohio'}, 'officialTitle': 'Decreased Opioid Consumption and Enhance Recovery With the Addition of IV-Acetaminophen in Colorectal Patients: A Prospective, Randomized, Double-Blinded, Placebo-Controlled Study', 'orgStudyIdInfo': {'id': 'JH 13-04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'IV acetaminophen group', 'description': 'In addition to PCA (morphine or hydromorphone) all patients receive 1 gram of IV acetaminophen (100 ml ) 30 minutes prior to operation and every 6 hours thereafter for up to 5 days post-operatively or discharge.', 'interventionNames': ['Drug: IV Acetaminophen']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Group', 'description': 'In addition to PCA (morphine or hydromorphone) all patients received placebo (100 ml normal saline) given 30 minutes prior to operation and every 6 hours thereafter for up to 5 days post-operatively or discharge', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'IV Acetaminophen', 'type': 'DRUG', 'description': '1 gram every 6 hours', 'armGroupLabels': ['IV acetaminophen group']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '100 ml of normal saline every 6 hours', 'armGroupLabels': ['Placebo Group']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jewish Hospital, Cincinnati, Ohio', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Amir H. Aryaie', 'investigatorAffiliation': 'Jewish Hospital, Cincinnati, Ohio'}}}}