Ignite Creation Date:
2025-12-24 @ 1:09 PM
Ignite Modification Date:
2025-12-31 @ 5:03 AM
Study NCT ID:
NCT04275661
Status:
UNKNOWN
Last Update Posted:
2022-04-19
First Post:
2020-02-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ketamine Versus Magnesium Sulphate as Adjuvants for ESPB in Breast Cancer Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}], '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'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019220', 'term': 'High-Energy Shock Waves'}, {'id': 'D000077554', 'term': 'Levobupivacaine'}, {'id': 'D007649', 'term': 'Ketamine'}, {'id': 'D008278', 'term': 'Magnesium Sulfate'}], 'ancestors': [{'id': 'D000069453', 'term': 'Ultrasonic Waves'}, {'id': 'D013016', 'term': 'Sound'}, {'id': 'D011840', 'term': 'Radiation, Nonionizing'}, {'id': 'D011827', 'term': 'Radiation'}, {'id': 'D055585', 'term': 'Physical Phenomena'}, {'id': 'D002045', 'term': 'Bupivacaine'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D017616', 'term': 'Magnesium Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D013431', 'term': 'Sulfates'}, {'id': 'D013464', 'term': 'Sulfuric Acids'}, {'id': 'D013456', 'term': 'Sulfur Acids'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2022-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-15', 'studyFirstSubmitDate': '2020-02-14', 'studyFirstSubmitQcDate': '2020-02-17', 'lastUpdatePostDateStruct': {'date': '2022-04-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'total morphine consumption in first 48 hours', 'timeFrame': '48 hours', 'description': 'determine the analgesic effect of ketamine and magnesium sulphate in decreasing morphine consumption'}, {'measure': 'time to first request of analgesia', 'timeFrame': '48 hours'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Analgesia', 'Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '31227568', 'type': 'BACKGROUND', 'citation': 'Altiparmak B, Korkmaz Toker M, Uysal AI, Gumus Demirbilek S. Bi-level erector spinae plane block for the control of severe back pain related to vertebral metastasis. BMJ Case Rep. 2019 Jun 20;12(6):e228129. doi: 10.1136/bcr-2018-228129.'}, {'pmid': '31044575', 'type': 'BACKGROUND', 'citation': 'Kwon WJ, Bang SU, Sun WY. Erector Spinae Plane Block for Effective Analgesia after Total Mastectomy with Sentinel or Axillary Lymph Node Dissection: a Report of Three Cases. J Korean Med Sci. 2018 Nov 5;33(45):e291. doi: 10.3346/jkms.2018.33.e291. No abstract available.'}, {'pmid': '29980005', 'type': 'BACKGROUND', 'citation': 'Gurkan Y, Aksu C, Kus A, Yorukoglu UH, Kilic CT. Ultrasound guided erector spinae plane block reduces postoperative opioid consumption following breast surgery: A randomized controlled study. J Clin Anesth. 2018 Nov;50:65-68. doi: 10.1016/j.jclinane.2018.06.033. Epub 2018 Jul 2.'}]}, 'descriptionModule': {'briefSummary': 'Our aim will be to compare the analgesic efficacy and safety of ketamine and magnesium sulphate as adjuvants to levobupivacaine in erector spinae plane block in modified radical mastectomy.', 'detailedDescription': 'The participating females will be randomly allocated using computer generated randomizer program (http://www.randomizer.org) into one of 3 groups.\n\nGroup (C) / (I): 20 patients (control group):\n\nPatient will receive 20 ml 0.25% levobupivacaine into interfascial plane below erector spinae muscle at level of T5 and T7.\n\nGroup (K) / (II): 20 patients (Ketamine group):\n\nPatient will receive 20ml 0.25% levobupivacaine as above + 2 mg /kg ketamine.\n\nGroup (M) / (III): 20 patients (magnesium sulphate group):\n\nPatient will receive 20ml 0.25% levobupivacaine as above + 2mg/kg MgSo4.\n\nStudy protocol:\n\nPremedication will be given, after complete fasting hours after applying standard monitors (noninvasive blood pressure, pulse oximetery. ECG, temp, and capnography), an intravenous cannula will be placed and secured in the opposite side to surgery.\n\nUltrasound guided Erector spinae plane (ESP) block will be given with patient in sitting position depending on surgical site (lt. or Rt.) ESP block will be given using high frequency linear u/s transducer, the probe is placed in longitudinal orientation lateral to thoracic fifth and seventh spinous process, then Trapezious m., Rhomboideus major muscle, and erector spinae muscle, are identified from surface, we will deposite 20 ml of 0.25% levobupivacairen into interfacial plane below erector spinae muscle.\n\nGeneral anesthesia will be induced with lμg/kg fentanyl, 2mg/kg propofol, 0.5 mg/kg atracurium inhalational anesthesia (isoflurane or sevoflurane)\n\n1gm paracetamol after induction No other narcotic, analgesic or sedative will be administrated during operative period.\n\nStandard monitor (MABP, HR , SaO2 \\& EtCo2) will be observed and recorded every 30 min till end of surgery Post-operative ; the patient will be transferred to the post anesthesia care unit (PACU). In PACU the following data included heart rate, mean blood pressure, respiratory rate and oxygen saturation and VAS scores (at rest and after movement in the form of abduction of ipsilateral arm ) at baseline,2,4,6,12,24 and 48 hours post-operatively to evaluate acute pain will be observed and recorded. The attending anesthesiologist, surgeon and the data collecting personal will be unaware of the patient assignment.\n\nRescue post-operative analgesia in the form of morphine Patient controlled analgesia (PCA ) with an initial bolus of 0.1 mg/ kg morphine once pain is expressed followed by 1mg bolus with a locked period of 15 minutes with no back ground infusion allowed. The time to first request of analgesia and the total analgesic consumption in the 1st 48 hour will be observed and recorded. Postoperative adverse effects will be observed and treated'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age of 18 - 60 years.\n* ASA grade I - II.\n\nExclusion Criteria:\n\n* Patient refusal. known allergy to the study drugs skin infection at site of needle puncture significant organ dysfunction Coagulopathy drug or alcohol abuse psychiatric illness that would interfere with perception and assessment of pain.'}, 'identificationModule': {'nctId': 'NCT04275661', 'briefTitle': 'Ketamine Versus Magnesium Sulphate as Adjuvants for ESPB in Breast Cancer Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Efficacy and Safety of Ketamine Versus Magnesium Sulphate as Adjuvants to Levobupivacaine in Ultrasound (US) Bi-level Erector Spinae Block in Breast Cancer Surgery', 'orgStudyIdInfo': {'id': 'ESPB in breast cancer surgery'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Group (C) (control group)', 'description': 'Patient will receive 10 ml 0.25% levobupivacaine into interfascial plane below erector spinae muscle at level of T5 and 10 ml at level of T7.', 'interventionNames': ['Procedure: Ultrasound (US) bi-level erector spinae block', 'Drug: levobupivacaine']}, {'type': 'EXPERIMENTAL', 'label': 'Group (K) (Ketamine group)', 'description': 'Patient will receive 10 ml 0.25% levobupivacaine into interfascial plane below erector spinae muscle at level of T5 and 10 ml at level of T7+ 1 mg / kg ketamine at each level with total dose 2mg/kg', 'interventionNames': ['Procedure: Ultrasound (US) bi-level erector spinae block', 'Drug: levobupivacaine', 'Drug: Ketamine']}, {'type': 'EXPERIMENTAL', 'label': 'Group (M) (magnesium sulphate group)', 'description': 'Patient will receive 10 ml 0.25% levobupivacaine into interfascial plane below erector spinae muscle at level of T5 and 10 ml at level of T7+ 1 mg / kg MgSo4 at each level with total dose 2mg/kg', 'interventionNames': ['Procedure: Ultrasound (US) bi-level erector spinae block', 'Drug: levobupivacaine', 'Drug: Magnesium Sulfate']}], 'interventions': [{'name': 'Ultrasound (US) bi-level erector spinae block', 'type': 'PROCEDURE', 'description': 'nerve block', 'armGroupLabels': ['Group (C) (control group)', 'Group (K) (Ketamine group)', 'Group (M) (magnesium sulphate group)']}, {'name': 'levobupivacaine', 'type': 'DRUG', 'description': '20 ml 0.25% levobupivacaine injected into fascial plane deep to erector spinae muscle', 'armGroupLabels': ['Group (C) (control group)', 'Group (K) (Ketamine group)', 'Group (M) (magnesium sulphate group)']}, {'name': 'Ketamine', 'type': 'DRUG', 'description': '2 mg /kg ketamine.injected into fascial plane deep to erector spinae muscle', 'armGroupLabels': ['Group (K) (Ketamine group)']}, {'name': 'Magnesium Sulfate', 'type': 'DRUG', 'description': '2mg/kg Magnesium Sulfate .injected into fascial plane deep to erector spinae muscle', 'armGroupLabels': ['Group (M) (magnesium sulphate group)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Asyut', 'country': 'Egypt', 'facility': 'south Egypt Cancer Institute Assiut University', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'overallOfficials': [{'name': 'khaled fares', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assiut University'}, {'name': 'hamdy abbas', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assiut University'}, {'name': 'fatma adel', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assiut University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ali Rabiee Ali', 'investigatorAffiliation': 'Assiut University'}}}}