Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2025-12-29 @ 10:38 PM
Study NCT ID:
NCT04445857
Status:
COMPLETED
Last Update Posted:
2025-04-08
First Post:
2020-06-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Coadministration of Calcitonin and Hyperbaric Bupivacaine in Spinal Anesthesia in Tramadol-abuse Patients
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': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2021-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-05', 'studyFirstSubmitDate': '2020-06-21', 'studyFirstSubmitQcDate': '2020-06-23', 'lastUpdatePostDateStruct': {'date': '2025-04-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The total dose of rescue analgesia (mg)', 'timeFrame': 'The first 24 hours after surgery', 'description': 'The total dose of rescue analgesia (mg)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Analgesia']}, 'descriptionModule': {'briefSummary': 'Increasing duration of local anesthetic action is desired for prolongation of postoperative patient comfort, as well as decreasing perioperative opioid consumption and subsequent side effects. Calcitonin, discovered in 1961, has been established, synthesized, and developed for use in treating disease. In 1983 it was demonstrated that calcitonin is an analgesic, which is also effective in the epidural and subarachnoid spaces.Tramadol abuse has dramatically increased in Egypt since 2008 and has led to many admissions to addiction treatment centers.It was shown that the duration of sensory block of spinal anesthesia with hyperbaric bupivacaine in chronic opium abusers undergoing lower extremity orthopedic surgery was much shorter in chronic opium abusers compared with non-abusers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with history of tramadol addiction (single drug addiction) and duration of addiction \\>1 year\n* Elective lower abdomen or lower extremities surgeries under spinal anesthesia\n* ASA physical status I and II\n\nExclusion Criteria:\n\n* Patient's refusal,\n* duration of surgery more than 120 min,\n* obesity with body mass index (BMI) \\>35 kg/m2,\n* generalized infection or localized infection at level of blockade,\n* neurological disease,\n* psychological disorder\n* coagulation disorder,\n* history of uncontrolled hypertension,\n* history of uncontrolled blood sugar,\n* allergy to bupivacaine or calcitonin"}, 'identificationModule': {'nctId': 'NCT04445857', 'briefTitle': 'Efficacy of Coadministration of Calcitonin and Hyperbaric Bupivacaine in Spinal Anesthesia in Tramadol-abuse Patients', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Efficacy of Coadministration of Calcitonin and Hyperbaric Bupivacaine in Spinal Anesthesia in Lower Abdominal and Limb Surgeries in Tramadol-abuse Patients: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'IRB 6379'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group 1', 'description': 'injection of 15 mg (3 ml) hyperbaric bupivacaine 0.5% and 100 IU salmon calcitonin(1ml) intrathecally and injection of 10 ml normal saline (NS) slowly intravenously (IV) over 5 min.', 'interventionNames': ['Drug: Calcitonin presented as Miacalcic® ampoules 100 IU/ml (1ml) intrathecally']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 2', 'description': 'injection of 15 mg (3 ml) hyperbaric bupivacaine 0.5% and 1ml NS intrathecally and injection of 100 IU salmon calcitonin (1ml) diluted in 9 ml NS slowly IV over 5 min.', 'interventionNames': ['Drug: Calcitonin presented as Miacalcic® ampoules 100 IU/ml (1ml) intravenously']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group 3 (control group)', 'description': 'injection of 15 mg (3 ml) hyperbaric bupivacaine 0.5% and 1ml NS intrathecally and injection of 10 ml NS slowly IV over 5 min.', 'interventionNames': ['Other: Normal Saline (NS)']}], 'interventions': [{'name': 'Calcitonin presented as Miacalcic® ampoules 100 IU/ml (1ml) intrathecally', 'type': 'DRUG', 'description': 'coadministration of calcitonin intrathecally and a single-shot hyperbaric bupivacaine', 'armGroupLabels': ['Group 1']}, {'name': 'Calcitonin presented as Miacalcic® ampoules 100 IU/ml (1ml) intravenously', 'type': 'DRUG', 'description': 'coadministration of calcitonin intravenously and a single-shot hyperbaric bupivacaine', 'armGroupLabels': ['Group 2']}, {'name': 'Normal Saline (NS)', 'type': 'OTHER', 'description': 'coadministration of normal saline and a single-shot hyperbaric bupivacaine', 'armGroupLabels': ['Group 3 (control group)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Ain-Shams University Hospitals', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Anesthesia and Intensive Care Department, Faculty of Medicine, Ain- shams University, Cairo, Egypt.', 'investigatorFullName': 'Ibrahim Mamdouh Esmat', 'investigatorAffiliation': 'Ain Shams University'}}}}