Ignite Creation Date:
2025-12-24 @ 9:33 PM
Ignite Modification Date:
2025-12-25 @ 7:17 PM
Study NCT ID:
NCT07182032
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-26
First Post:
2025-09-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ketamine in Central Sensitization
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004715', 'term': 'Endometriosis'}], 'ancestors': [{'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007649', 'term': 'Ketamine'}], 'ancestors': [{'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 126}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2028-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-24', 'studyFirstSubmitDate': '2025-09-16', 'studyFirstSubmitQcDate': '2025-09-16', 'lastUpdatePostDateStruct': {'date': '2025-11-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2028-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in pain as measured by visual analog scale', 'timeFrame': 'approximately post-operative day 0 and 14', 'description': 'A Visual Analog Scale (VAS) is a tool for patients to rate their pain on a 100mm line, where "no pain" is at one end and "worst pain imaginable" is at the other.'}], 'secondaryOutcomes': [{'measure': 'Intraoperative opioid consumption as measured by anesthesia charting', 'timeFrame': 'Intraoperatively up to 8 hours', 'description': 'Reported in morphine equivalents'}, {'measure': 'change in postoperative pain scores measured by numerical rating scale', 'timeFrame': 'approximately postoperative day 0 and 14', 'description': 'NRS is a simple and widely used pain assessment tool that asks patients to rate their pain intensity on a scale from 0 (no pain) to 10 (severe pain).'}, {'measure': 'incidence of postoperative nausea/vomiting as measured by patient report', 'timeFrame': 'postoperative day 0'}, {'measure': 'change in total analgesic consumption post-surgery as measured by chart review and patient report', 'timeFrame': 'approximately postoperative day 0, 1 and 14', 'description': 'measured in morphine milliequivalents'}, {'measure': 'incidence of postoperative delirium as measured by chart review', 'timeFrame': 'postoperative day 0'}, {'measure': 'change in central sensitization as measured by central sensitization inventory (CSI) score', 'timeFrame': 'approximately postoperative day 0 and 14', 'description': 'The CSI consists of 25 questions, each rated on a 0-4 scale (0 = never, 4 = always). The total score ranges from 0 to 100. Higher scores indicate a greater degree of central sensitization.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ketamine', 'central sensitization'], 'conditions': ['Endometriosis', 'Chronic Pelvic Pain']}, 'descriptionModule': {'briefSummary': 'The purpose of this research study is to see if ketamine infusion during surgery can decrease pain after surgery. Ketamine is a medication commonly used as part of anesthesia during surgery and is approved by the US FDA.\n\nPatients will be randomized to either receive standard anesthesia with OR without ketamine. The surgical procedure will be the same regardless of which group patients are randomized to. After surgery, patients will be asked to rate their pain in the post-operative observation unit and at their two-week post-operative visit. No additional visits are required for participation in this study. The investigators estimate the surveys will take approximately 10 minutes to complete.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age range 18-89\n* ASA classification I-III\n* outpatient elective laparoscopy for endometriosis\n\nExclusion Criteria:\n\n* known allergy or contraindication to ketamine\n* History of substance use disorder, including alcohol or marijuana use, both current and remote\n* History of severe psychiatric illness, including schizoaffective disorder, bipolar disorder, psychosis, or decompensated psychiatric condition , excluding anxiety and depression\n* Current Intraoperative complications'}, 'identificationModule': {'nctId': 'NCT07182032', 'briefTitle': 'Ketamine in Central Sensitization', 'organization': {'class': 'OTHER', 'fullName': 'University Hospitals Cleveland Medical Center'}, 'officialTitle': 'Ketamine Use in Central Sensitization: a Study Evaluating the Use of Ketamine in Centrally Sensitized Endometriosis Patients', 'orgStudyIdInfo': {'id': 'STUDY20250700'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'standard general anesthesia without ketamine'}, {'type': 'EXPERIMENTAL', 'label': 'Ketamine', 'description': 'standard general anesthesia with ketamine', 'interventionNames': ['Drug: ketamine']}], 'interventions': [{'name': 'ketamine', 'type': 'DRUG', 'description': 'Participants will receive general anesthesia with protocoled ketamine infusion', 'armGroupLabels': ['Ketamine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'contacts': [{'name': 'Adi Cosic, DO', 'role': 'CONTACT', 'email': 'adi.cosic2@uhhospitals.org', 'phone': '216-844-2273'}], 'facility': 'University Hospitals Cleveland Medical Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'centralContacts': [{'name': 'Adi Cosic, MD', 'role': 'CONTACT', 'email': 'adi.cosic2@uhhospitals.org', 'phone': '216-844-2273'}], 'overallOfficials': [{'name': 'Adi Cosic, DO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospitals'}, {'name': 'Morgan Cheeks, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hosptials'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospitals Cleveland Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Physician', 'investigatorFullName': 'Adi Cosic', 'investigatorAffiliation': 'University Hospitals Cleveland Medical Center'}}}}