Ignite Creation Date:
2025-12-25 @ 12:21 AM
Ignite Modification Date:
2025-12-25 @ 10:24 PM
Study NCT ID:
NCT05813158
Status:
COMPLETED
Last Update Posted:
2023-05-03
First Post:
2022-11-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparing the Perioperative Analgesic Effect of Two Different Volumes of Local Anesthetic Solution in Erector Spinae Plane Block in Patients Undergoing Modified Radical Mastectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Patients will be randomly allocated to one of the two groups by sealed closed envelop technique'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'We hypothesize that high volume low concentration ultrasound-guided Erector Spinae Plane block is going to be more effective than low volume high concentration in patients undergoing MRM. Many authors advocate increasing the volume of injection in fascial plane blocks to allow better spread of local anesthetic according to multiple studies'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-09-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2022-12-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-28', 'studyFirstSubmitDate': '2022-11-18', 'studyFirstSubmitQcDate': '2023-04-13', 'lastUpdatePostDateStruct': {'date': '2023-05-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total dose of morphine needed postoperatively', 'timeFrame': 'Through Study Completion Up to 1 Day', 'description': 'Total dose of morphine needed postoperatively'}], 'secondaryOutcomes': [{'measure': 'Time to first rescue analgesia, starting after extubation', 'timeFrame': 'Through Study Completion over the first 24 hours postoperative', 'description': 'Time to first rescue analgesia, starting after extubation'}, {'measure': 'Duration of surgery', 'timeFrame': 'Through Study Completion 24 hours postoperative', 'description': 'Duration of surgery'}, {'measure': 'Blood loss,', 'timeFrame': 'Through Study Completion,an average of 1day', 'description': 'Blood loss,'}, {'measure': 'Total dose of fentanyl required intraoperative (including induction dose)', 'timeFrame': 'Through study completion,an average of 1day', 'description': 'Total dose of fentanyl required intraoperative (including induction dose)'}, {'measure': 'Pain score at 15, 30, 45 and 60 min., 3,6,12 and 24 h after surgery', 'timeFrame': 'through study completion,an average of 1day', 'description': 'Pain score at 15, 30, 45 and 60 min., 3,6,12 and 24 h after surgery'}, {'measure': 'Need for blood transfusion', 'timeFrame': 'Through Study Completion over the first 24 hours postoperative', 'description': 'Need for blood transfusion'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Comparing of 2 Different Volumes in ESPB in Patients Undergoing MRM']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to compare and evaluate the analgesic effects of ultrasound-guided Erector Spinae Plane block using low volumes and high concentrations versus high volumes and low concentrations in patients undergoing MRM.', 'detailedDescription': 'Multiple regional techniques have been developed in recent years for postoperative analgesia of breast surgery including ESPB aiming to be effective and associated with less complications when compared to the gold standard techniques (thoracic epidural analgesia or paravertebral block)..\n\nUltrasound guided erector spinae plane (ESPB) block was described in 2016 as a novel regional anesthetic technique for acute and chronic thoracic pain, it has been used as a regional anesthetic technique for breast surgery based on case reports and case series. It is a paraspinal fascial plane block that involves injection of local anesthetic deep in the erector spinae muscle and superficial to the tips of the thoracic transverse processes. The site of injection is distant from the pleura, major blood vessels, and spinal cord; hence, performing the ESPB has relatively few contraindications. The injected local anesthetic drug blocks the ventral and dorsal rami of spinal nerves on the paravertebral area .\n\nMultiple studies have reported improved efficiency of interfascial blocks by increasing the volume of injection promoting better spread of local anesthesia. According to the authors best knowledge there is no studies comparing different volumes and concentration in ESPB in patients undergoing MRM This study aims to see the effect of fixing the drug mass of anaesthetic given in both groups, while altering the concentration of the anesthetic and total volume administered. One group will receive a lower concentration and higher volume, while the other will receive a higher concentration and lower volume.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAge starting from 18 to 60 years.\n\n* Genders eligible for study: female sex.\n* ASA II-III.\n* Patients undergoing modified radical mastectomy.\n* Body mass index (BMI) from 18.5 to 30 kg/m2.\n\nExclusion Criteria:\n\nPatient refusal\n\n* Known allergy to local anesthetics\n* Bleeding disorders; platelets count \\<50,000, prothrombin concentration \\<60% or any coagulopathy disorder.\n* Use of any anti-coagulants\n* Inability to provide informed consent\n* ASA IV\n* Neurological disorders\n* Patient with psychiatric disorders'}, 'identificationModule': {'nctId': 'NCT05813158', 'briefTitle': 'Comparing the Perioperative Analgesic Effect of Two Different Volumes of Local Anesthetic Solution in Erector Spinae Plane Block in Patients Undergoing Modified Radical Mastectomy', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Comparing the Perioperative Analgesic Effect of Two Different Volumes of Local Anesthetic Solution in Erector Spinae Plane Block in Patients Undergoing Modified Radical Mastectomy A Randomized Comparative Study', 'orgStudyIdInfo': {'id': 'N-44-2022/MSc'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group 1', 'description': 'Patients will preoperatively receive low concentration-high volume U/S ESP block, and then the patient will be transferred to the operating room one syringe of 30ml bupivacaine 0.25% {15 ml bupivacaine 0.5% and 15ml normal saline}, for each patient.', 'interventionNames': ['Drug: Group 1(low concentration-high volume bupivacaine US guided Erector Spinae Plane block)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 2', 'description': 'Patients will preoperatively receive high concentration-low volume U/S ESP block block, and then the patient will be transferred to the operating room one syringe of 15 ml bupivacaine 0.5% {15 ml bupivacaine 0.5% }, for each patien).', 'interventionNames': ['Drug: Group 2(high concentration-low volumecbupivacaine US guided Erector Spinae Plane block)']}], 'interventions': [{'name': 'Group 1(low concentration-high volume bupivacaine US guided Erector Spinae Plane block)', 'type': 'DRUG', 'otherNames': ['Erector Spinae Plane Block with high volume-low concentration bupivacaine 0.25%'], 'description': 'Patients will preoperatively receive low concentration-high volume ultasound guided Erector Spinae Plane block, and then the patient will be transferred to the operating room ) one syringe of 30ml bupivacaine 0.25% {15 ml bupivacaine 0.5% and 15ml normal saline} for each patient', 'armGroupLabels': ['Group 1']}, {'name': 'Group 2(high concentration-low volumecbupivacaine US guided Erector Spinae Plane block)', 'type': 'DRUG', 'otherNames': ['Erector Spinae Plane Block with low volume-high concentration bupivacaine 0.25%'], 'description': 'Patients will preoperatively receive high concentration-low volume ultasound guided Erector Spinae Plane block, and then the patient will be transferred to the operating room (one syringe of 15 ml bupivacaine 0.5% {15 ml bupivacaine 0.5% } for each patien).', 'armGroupLabels': ['Group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11451', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Ahmed Abdalla Mohamed', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Ahmed Abdalla Mohamed, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cairo University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Till Study Ending'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Yasmina sayed Abdrabo Ismael', 'class': 'UNKNOWN'}, {'name': 'Norhan Abdelaleem Ali', 'class': 'UNKNOWN'}, {'name': 'Ahmed Shaker Ragab', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Anesthesia &I.C.U and Pain Clinic, Cairo University', 'investigatorFullName': 'Ahmed Abdalla', 'investigatorAffiliation': 'Cairo University'}}}}