Ignite Creation Date:
2025-12-24 @ 5:16 PM
Ignite Modification Date:
2025-12-30 @ 2:36 AM
Study NCT ID:
NCT05946850
Status:
RECRUITING
Last Update Posted:
2025-01-27
First Post:
2023-07-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Caudal Analgesia & Anticoagulated Patient
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013001', 'term': 'Somatoform Disorders'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2008-01-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-23', 'studyFirstSubmitDate': '2023-07-07', 'studyFirstSubmitQcDate': '2023-07-07', 'lastUpdatePostDateStruct': {'date': '2025-01-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain score, objective measurement using the validated Numeric Pain Rating scale', 'timeFrame': '12 weeks', 'description': 'Pain score, using the Numeric Pain Rating scale of 0 to 10, low scores indicate less pain, high scores indicate worse pain'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Caudal analgesia'], 'conditions': ['Lumbar Pain Syndrome', 'Anticoagulants and Bleeding Disorders']}, 'referencesModule': {'references': [{'pmid': '19644537', 'type': 'BACKGROUND', 'citation': 'Manchikanti L, Boswell MV, Singh V, Benyamin RM, Fellows B, Abdi S, Buenaventura RM, Conn A, Datta S, Derby R, Falco FJ, Erhart S, Diwan S, Hayek SM, Helm S, Parr AT, Schultz DM, Smith HS, Wolfer LR, Hirsch JA; ASIPP-IPM. Comprehensive evidence-based guidelines for interventional techniques in the management of chronic spinal pain. Pain Physician. 2009 Jul-Aug;12(4):699-802.'}]}, 'descriptionModule': {'briefSummary': 'Caudal analgesia is an effective intervention for lumbosacral pain. Some chronic pain patients take anticoagulants for vasculopathy treatment. Anticoagulation limits the use of caudal analgesia because of the risk of epidural bleeding. Caudal analgesia may be safe and effective in anticoagulated chronic pain patients.\n\nQuantitative analysis of prospective clinical data. Evaluation of caudal analgesia efficacy and safety in anticoagulated chronic pain patients. Analysis of outcome, and complications.', 'detailedDescription': 'Caudal analgesia is an effective interventional therapy for chronic lumbosacral pain. Some chronic pain patients take anticoagulants for vasculopathy treatment. Anticoagulation limits the use of caudal analgesia because of the risk of epidural bleeding. Anticoagulation may be discontinued briefly, to allow caudal injection. Interruption of anticoagulation may be difficult and dangerous for some high-risk patients. Caudal analgesia may be safe and effective in anticoagulated chronic pain patients.\n\nQuantitative analysis of prospective clinical data. An evaluation of caudal analgesia safety in anticoagulated chronic pain patients. An analysis of treatment outcome, and complications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult chronic pain clinic patients who have lumbosacral pain, and undergo caudal analgesia', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult chronic pain patients who undergo caudal analgesia\n\nExclusion Criteria:\n\n* chronic pain patients who refuse caudal analgesia'}, 'identificationModule': {'nctId': 'NCT05946850', 'briefTitle': 'Caudal Analgesia & Anticoagulated Patient', 'organization': {'class': 'OTHER', 'fullName': 'Salem Anaesthesia Pain Clinic'}, 'officialTitle': 'Caudal Analgesia in Anticoagulated Chronic Pain Patients', 'orgStudyIdInfo': {'id': 'Salem2018 Caudal Blk Anticoag'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Caudal analgesia', 'type': 'PROCEDURE', 'description': 'Caudal analgesia for chronic lumbosacral pain'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V3S 7J1', 'city': 'Surrey', 'state': 'British Columbia', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Olumuyiwa Bamgbade, MD, FRCPC', 'role': 'CONTACT', 'email': 'salem.painclinic@gmail.com', 'phone': '+17786286600'}], 'facility': 'Salem Anaesthesia Pain Clinic', 'geoPoint': {'lat': 49.10635, 'lon': -122.82509}}], 'centralContacts': [{'name': 'Olu Bamgbade, MD,FRCPC', 'role': 'CONTACT', 'email': 'salem.painclinic@gmail.com', 'phone': '17786286600'}, {'name': 'Olumuyiwa Bamgbade, MD,FRCPC', 'role': 'CONTACT', 'email': 'olu.bamgbade@gmail.com', 'phone': '7786286600'}], 'overallOfficials': [{'name': 'Olu Bamgbade, MD,FRCPC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Salem Anaesthesia Pain Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Salem Anaesthesia Pain Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}