Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2025-12-25 @ 9:47 PM
Study NCT ID:
NCT03477851
Status:
COMPLETED
Last Update Posted:
2021-10-28
First Post:
2018-03-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Tramadol Simultaneously With Sciatic Nerve Block for Calcaneus Fracture Osteosynthesis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059787', 'term': 'Acute Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014147', 'term': 'Tramadol'}], 'ancestors': [{'id': 'D003511', 'term': 'Cyclohexanols'}, {'id': 'D000441', 'term': 'Hexanols'}, {'id': 'D005233', 'term': 'Fatty Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004123', 'term': 'Dimethylamines'}, {'id': 'D008744', 'term': 'Methylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER'], 'maskingDescription': 'Trained care provider (nurse) prepares the active drug or placebo directly before the procedure according to randomisation list (secured).'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized, double blinded two-arm parallel assignment'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2020-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-27', 'studyFirstSubmitDate': '2018-03-19', 'studyFirstSubmitQcDate': '2018-03-23', 'lastUpdatePostDateStruct': {'date': '2021-10-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall analgesic in 24h', 'timeFrame': '24hour', 'description': 'Overall Morphine hydrochloride dose in the first 24h after intervention'}], 'secondaryOutcomes': [{'measure': 'Time to block resolution', 'timeFrame': '24hour', 'description': 'Time from the intervention to complete motoric block resolution'}, {'measure': 'Time to first analgesic', 'timeFrame': '24hour', 'description': 'Time from the intervention (sciatic nerve block/i.m.drug) to the first bolus of Morphine hydrochloride'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sciatic nerve block', 'tramadol', 'foot fracture'], 'conditions': ['Foot Fracture', 'Pain, Acute']}, 'descriptionModule': {'briefSummary': 'Comparison of duration of efficient analgesia after painful surgical repair od foot fractures between groups treated with sciatic nerve block alone and sciatic nerve block simultaneously with i.m. tramadol', 'detailedDescription': 'A randomized, double-blinded study in patients scheduled for surgical repair of foot fractures in spinal anaesthesia where two pain treatment modalities would be compared. One group receives sciatic nerve block with standardized dosis od bupivacaine under ultrasound visualisation, while the other group receives the same block but with simultaneous i.m. injection of tramadol (also standardized). Both the patient and the anaesthesist are blinded, i.e. the control group receives simultaneously with the block a 0,9% sodium hydrochloride injected. Drug or control syringes do not differ, and would be prepared directly before in a randomised, blinded manner by trained co-investigator. Both group receive also the same standardised systemic analgetics with no further use of tramadol.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with foot fracture scheduled for surgical repair in spinal anesthesia\n* Informed consent\n\nExclusion Criteria:\n\n* No consent\n* Spinal anesthesia or sciatic nerve block contraindicated\n* Known intolerance to tramadol or other contraindications for the drug'}, 'identificationModule': {'nctId': 'NCT03477851', 'acronym': 'TramIsch', 'briefTitle': 'Tramadol Simultaneously With Sciatic Nerve Block for Calcaneus Fracture Osteosynthesis', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Warsaw'}, 'officialTitle': 'Evaluation of the Influence of Tramadol Injection Simultaneous With Sciatic Nerve Block on the Duration of Efficient Sensory Blockade in Patients Operated on for Calcaneus Fracture', 'orgStudyIdInfo': {'id': 'WNOZA/1/2017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Patients randomized to receive 0,9% sodium hydrochloride solution 5ml i.m. (gluteus muscle) after spinal anesthesia, simultaneously with the sciatic nerve block.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Tramadol', 'description': 'Patients randomized to receive 100mg of Tramadol hydrochloride in 5ml 0,9% sodium hydrochloride i.m. (gluteus muscle) after spinal anesthesia, simultaneously with the sciatic nerve block.', 'interventionNames': ['Drug: Tramadol Hydrochloride']}], 'interventions': [{'name': 'Tramadol Hydrochloride', 'type': 'DRUG', 'otherNames': ['Tramadol i.m.'], 'description': 'Tramadol i.m. simultaneous with sciatic nerve block', 'armGroupLabels': ['Tramadol']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['0,9%NaCl i.m.'], 'description': '0,9%NaCl i.m. simultaneous with sciatic nerve block', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02-005', 'city': 'Warsaw', 'state': 'Masovian Voivodeship', 'country': 'Poland', 'facility': 'Dept.of Anesthesia and Intensive Care, Warsaw Medical University', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}], 'overallOfficials': [{'name': 'Janusz Trzebicki, Dr hab.', 'role': 'STUDY_CHAIR', 'affiliation': 'Medical University of Warsaw'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Warsaw', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}