Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2025-12-26 @ 2:34 AM
Study NCT ID:
NCT04579302
Status:
COMPLETED
Last Update Posted:
2021-03-09
First Post:
2020-09-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Serratus Anterior Block and Erector Spinae Block in Postoperative Analgesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D012965', 'term': 'Sodium Chloride'}, {'id': 'D002045', 'term': 'Bupivacaine'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2021-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-08', 'studyFirstSubmitDate': '2020-09-24', 'studyFirstSubmitQcDate': '2020-10-07', 'lastUpdatePostDateStruct': {'date': '2021-03-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'total morphine consumption in first postoperative 24 hours', 'timeFrame': 'first 24 postoperative hours', 'description': 'the amount of morphine required to relieve pain will be recorded'}], 'secondaryOutcomes': [{'measure': 'intraoperative fentanyl requirement', 'timeFrame': 'during anaesthesia', 'description': 'the amount of fentanyl required during anaesthesia will be recorded'}, {'measure': 'numerical rating scale', 'timeFrame': 'the first 24 postoperative hours', 'description': 'numerical rating scale (from 0 to 10, where 0 represents no pain and 10 represents the worst imaginable pain) will be recorded in different time intervals during the first 24 hours after surgery'}, {'measure': 'pulmonary functions', 'timeFrame': '24 hours after surgery', 'description': 'FVC and FEV1 will be recorded at 24 hours after surgery'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Serratus anterior block', 'Erector spinae block', 'Postoperative analgesia'], 'conditions': ['Postoperative Analgesia']}, 'descriptionModule': {'briefSummary': '90 patients scheduled for thoracic cancer surgeries, allocated in 3 groups for serratus anterior block and erector spinae block and control group. during anaesthesia:total intraoperative fentanyl required will be recorded. After surgery, all patients will be connected to PCA device containing morphine solution, the amount of morphine consumed during the first 24 hours will be recorded.', 'detailedDescription': '90 patients scheduled for thoracic cancer surgeries, allocated in 3 groups for serratus anterior block (SAB) and erector spinae block (ESB) and control group. During anaesthesia: total intraoperative fentanyl required will be recorded. After surgery, all patients will be connected to PCA device containing morphine solution, the amount of morphine consumed during the first 24 hours will be recorded. Other secondary outcomes are: numerical rating scales and postoperative pulmonary functions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with class II physical status (American Society of Anaesthesiologists) ,\n* Age between 18-70 years,\n* Scheduled for thoracic cancer surgery\n\nExclusion Criteria:\n\n* Patient refusal.\n* Local infection at the site of the block.\n* Cardiac dysfunction (ejection fraction \\<45%).\n* Significant respiratory disorders.\n* Preexisting neurological or psychiatric disease.\n* Allergy to one of the study drugs.\n* Pregnancy.\n* Coagulopathy'}, 'identificationModule': {'nctId': 'NCT04579302', 'briefTitle': 'Serratus Anterior Block and Erector Spinae Block in Postoperative Analgesia', 'organization': {'class': 'OTHER', 'fullName': 'National Cancer Institute, Egypt'}, 'officialTitle': 'Evaluation of the Effect of Serratus Anterior Block and Erector Spinae Block on Postoperative Analgesia in Thoracic Surgeries', 'orgStudyIdInfo': {'id': 'AP2007-50105'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'serratus anterior block', 'description': 'serratus anterior block with 20 ml bupivacaine', 'interventionNames': ['Procedure: Serratus anterior block (SAB)', 'Drug: Bupivacaine']}, {'type': 'EXPERIMENTAL', 'label': 'erector spinae block', 'description': 'erector spinae block with 20 ml bupivacaine', 'interventionNames': ['Procedure: Erector spinae block', 'Drug: Bupivacaine']}, {'type': 'SHAM_COMPARATOR', 'label': 'control group', 'description': 'sham block with 20 ml saline', 'interventionNames': ['Drug: Saline (as a placebo)']}], 'interventions': [{'name': 'Serratus anterior block (SAB)', 'type': 'PROCEDURE', 'otherNames': ['SAB group'], 'description': 'Patients will receive a sonar guided serratus anterior plane block with 20 ml of bupivacaine 0.5%', 'armGroupLabels': ['serratus anterior block']}, {'name': 'Erector spinae block', 'type': 'PROCEDURE', 'otherNames': ['ESB group'], 'description': 'Patients will receive a sonar-guided erector spinae plane block with 20 ml of bupivacaine 0.5%', 'armGroupLabels': ['erector spinae block']}, {'name': 'Saline (as a placebo)', 'type': 'DRUG', 'description': 'Patients will receive a sham block with 20 ml saline (as a placebo)', 'armGroupLabels': ['control group']}, {'name': 'Bupivacaine', 'type': 'DRUG', 'description': 'bupivacaine', 'armGroupLabels': ['erector spinae block', 'serratus anterior block']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'National Cancer Institute', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Mohamed E Hassan, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Cancer Institute - Vairo University - Egypt'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Institute, Egypt', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}