Ignite Creation Date:
2025-12-24 @ 4:36 PM
Ignite Modification Date:
2025-12-29 @ 4:18 AM
Study NCT ID:
NCT06039566
Status:
RECRUITING
Last Update Posted:
2025-10-14
First Post:
2023-08-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
NAC vs Placebo on Opioid Use for Hysterectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000111', 'term': 'Acetylcysteine'}], 'ancestors': [{'id': 'D003545', 'term': 'Cysteine'}, {'id': 'D000603', 'term': 'Amino Acids, Sulfur'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 240}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-12-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-10', 'studyFirstSubmitDate': '2023-08-25', 'studyFirstSubmitQcDate': '2023-09-08', 'lastUpdatePostDateStruct': {'date': '2025-10-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-09-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'intraoperative opioid consumption', 'timeFrame': 'during the procedure (up to 12 hours)', 'description': 'Total morphine milligram equivalents administered during the procedure'}, {'measure': 'postoperative anesthesia care unit (PACU) opioid consumption', 'timeFrame': 'PACU Arrival until PACU Discharge up to 52 weeks', 'description': 'Total morphine milligram equivalents administered in the PACU'}, {'measure': 'non-opioid analgesic administration', 'timeFrame': 'Anesthesia start until PACU discharge up to 52 weeks', 'description': 'Total other pain medication administered during the procedure and in PACU'}], 'primaryOutcomes': [{'measure': 'Opioid Consumption 0-72 hours post-study medication', 'timeFrame': '0-72 hours after study medication', 'description': '72-hour post-medication opioid consumption.'}], 'secondaryOutcomes': [{'measure': 'Pain Scores', 'timeFrame': 'Study medication start to 72 hours post-study medication', 'description': 'Using a Visual Analog Scale from 0-100, patients will report pain scores from 0-72 hours post-medication. A lower pain score means a better outcome.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hysterectomy'], 'conditions': ['Hysterectomy']}, 'descriptionModule': {'briefSummary': 'This study will enroll females who are ages 18 and older undergoing a laparoscopic or robotic, partial or full hysterectomy. Participants will be randomized to receive IV n-acetylcysteine or placebo during the first 60 minutes of their procedure. At various time points after the procedure patients will be asked to report their pain scores, and any pain medication taken.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Female', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion\n\n* Undergoing elective laparoscopic or robotic, full, or partial hysterectomy procedure\n* 18 years of age and older\n\nExclusion\n\n* Less than 40kg in weight\n* Unable to provide written, informed consent\n* History of an adverse or anaphylactoid reaction to acetylcysteine\n* Active asthma, wheezing, or using inhaled bronchodilators\n* Non-English speaking\n* Insulin dependent diabetes if D5W is required\n* Blood clotting disorders'}, 'identificationModule': {'nctId': 'NCT06039566', 'briefTitle': 'NAC vs Placebo on Opioid Use for Hysterectomy', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of South Carolina'}, 'officialTitle': 'A Trial Evaluating the Impact of N-acetylcysteine on Opioid Use in Patients Undergoing a Hysterectomy Procedure', 'orgStudyIdInfo': {'id': 'Pro00130489'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'IV Placebo', 'description': 'Patients will receive: Placebo 0 mg/kg (placebo: 0.45% NaCl or D5W) through an IV that will run for 60 minutes at the start of the procedure.', 'interventionNames': ['Drug: IV Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'IV N-acetylcysteine', 'description': 'Patients will receive: N-acetylcysteine (NAC) 150 mg/kg (Max dose 15,000 mg) through an IV that will run for 60 minutes at the start of the procedure.', 'interventionNames': ['Drug: IV N-acetylcysteine']}], 'interventions': [{'name': 'IV N-acetylcysteine', 'type': 'DRUG', 'otherNames': ['NAC'], 'description': 'N-acetylcysteine (NAC) 150 mg/kg (Max dose 15,000 mg) through an IV that will run for 60 minutes at the start of the procedure', 'armGroupLabels': ['IV N-acetylcysteine']}, {'name': 'IV Placebo', 'type': 'DRUG', 'otherNames': ['Placebo'], 'description': 'Placebo 0 mg/kg (placebo: 0.45% NaCl or D5W) through an IV that will run for 60 minutes at the start of the procedure.', 'armGroupLabels': ['IV Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sylvia Wilson, MD', 'role': 'CONTACT', 'email': 'wilsosh@musc.edu', 'phone': '843-792-2322'}, {'name': 'Sylvia Wilson, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}], 'centralContacts': [{'name': 'Haley Nitchie, MHA', 'role': 'CONTACT', 'email': 'nitchie@musc.edu', 'phone': '843-792-1869'}], 'overallOfficials': [{'name': 'Sylvia Wilson, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of South Carolina'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of South Carolina', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Anesthesiology', 'investigatorFullName': 'Sylvia Wilson', 'investigatorAffiliation': 'Medical University of South Carolina'}}}}