Ignite Creation Date:
2025-12-24 @ 9:57 PM
Ignite Modification Date:
2025-12-25 @ 7:35 PM
Study NCT ID:
NCT05547932
Status:
COMPLETED
Last Update Posted:
2023-04-19
First Post:
2022-08-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Rhomboid Intercostal Block and Serratus Anterior Plane Block on Postoperative Respiratory Functions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D012131', 'term': 'Respiratory Insufficiency'}, {'id': 'D000377', 'term': 'Agnosia'}, {'id': 'D053120', 'term': 'Respiratory Aspiration'}], 'ancestors': [{'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'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The patients will be under general anesthesia and will not know if they received a block procedure or not.\n\nThe investigator, the data collector and the outcome assessor will be completely blind to the study groups. Only the care provider who will perform the block procedures will know the study groups.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective, randomized, controlled study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-09-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-04-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-15', 'studyFirstSubmitDate': '2022-08-10', 'studyFirstSubmitQcDate': '2022-09-18', 'lastUpdatePostDateStruct': {'date': '2023-04-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Forced Expiratory Volume in 1 second (FEV1)', 'timeFrame': 'postoperative 2nd hour', 'description': 'FEV1 of the patients in the block group will be higher at the postoperative second hour than the patients in the control group'}], 'secondaryOutcomes': [{'measure': 'Postoperative pain', 'timeFrame': 'Postoperative second hour', 'description': 'The pain scores of the patients in the block group will be lower than the patients in the control group at the postoperative second hour.'}, {'measure': 'Postoperative opioid consumption', 'timeFrame': 'Postoperative 24th hour', 'description': 'The opioid consumption of the patients in the block group will be lower than the patients in the control group at the postoperative 24th hour.'}, {'measure': 'Forced Vital Capacity (FVC)', 'timeFrame': 'postoperative 2nd hour', 'description': 'FVC value of the patients in the block group will be higher at the postoperative second hour than the patients in the control group'}, {'measure': 'FEV1/FVC', 'timeFrame': 'postoperative 2nd hour', 'description': 'FEV1/FVC value of the patients in the block group will be higher at the postoperative second hour than the patients in the control group'}, {'measure': 'forced expiratory flow at 25-75% of forced vital capacity (FEF25-75)', 'timeFrame': 'postoperative 2nd hour', 'description': 'FEF25-75 values of the patients in the block group will be higher at the postoperative second hour than the patients in the control group'}, {'measure': 'Peak expiratory flow (PEF)', 'timeFrame': 'postoperative 2nd hour', 'description': 'PEF values of the patients in the block group will be higher at the postoperative second hour than the patients in the control group'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Analgesia', 'postoperative pain', 'rhomboid intercostal block', 'serratus anterior plane block', 'respiratory function'], 'conditions': ['Breast Cancer', 'Postoperative Pain', 'Respiratory Function Impaired']}, 'descriptionModule': {'briefSummary': 'Rhomboid intercostal block is used to block lateral cutaneous branches of intercostal nerves between T3 and T9 dermatomes. Serratus anterior plane block is used to block lateral cutaneous branches of intercostal nerves between T2 and T6, in addition, it is also known to block thoracodorsal nerve and long thoracic nerve. Both of the blocks are usually performed for postoperative analgesia following breast surgery. The primary hypothesis of the study is that FEV1 value of the patients who will receive modified radical mastectomy (MRM) and rhomboid intercostal plane (RIP) block combined with serratus anterior plane (SAP) will be higher than FEV1 value of the patients in the no-block group. The secondary hypothesis is that RIP+SAP blocks will provide reduction in the pain scores and opioid consumption in the postoperative first 24 hours.', 'detailedDescription': 'The patients who are scheduled for MRM under general anesthesia, aged between 18-65 years and ASA scores I-II will be included in the study. Respiratory functions (FEV₁, FVC, FEV₁/FVC, PEF, FEF25-75) of the patients will be measured by a hand-held spirometry device prior to the operation in the surgical ward. The induction of anesthesia will be provided similarly in all patients, then patients will be intubated and randomly divided into two groups. One group will receive RIP+SAP block using 40 milliliters of %0.25 bupivacaine and patients in the control group will receive no block procedures. The standard analgesia will be provided by intraoperative intravenous (iv) infusion of dexketoprofen 50 mg and iv tramadol 1 mg/kg which will be administered in 15 minutes before end of the surgery. Respiratory functions of the patients will be measured at the postoperative 2nd, 4th and 24th hours. Pain intensity of the patients will be evaluated by Numerical Rating Scale (NRS) which is a scale ranges between 0 (no pain) and 10 (the worst pain that a person can stand). NRS scores will be evaluated at the postoperative 15th, 30th minutes and 1st, 2nd, 6th, 12th and 24th hours, and opioid consumption will be recorded at the postoperative 24th hour.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA I-II patients\n* Female\n* Ages between 18-65\n* Patients who will receive breast cancer surgery under general anesthesia\n\nExclusion Criteria:\n\n* Known respiratory diseases\n* Rhinitis and atopic dermatitis story\n* New York Heart Association Class equal to higher than class 2\n* Respiratory diseases story in the last two weeks\n* Alchol or substance or chronic opioid consumption story\n* Any pain killers intake in the last 24 hours prior to surgery\n* Active smokers or ex-smokers\n* Body mass index over 35 kg/m2\n* İnfection at the injection sites\n* Known allergy to local anesthetics\n* Known psychiatric diseases\n* Operations longer than 3 hours'}, 'identificationModule': {'nctId': 'NCT05547932', 'acronym': 'RIBSAB', 'briefTitle': 'The Effect of Rhomboid Intercostal Block and Serratus Anterior Plane Block on Postoperative Respiratory Functions', 'organization': {'class': 'OTHER', 'fullName': 'Muğla Sıtkı Koçman University'}, 'officialTitle': 'The Effect of Ultrasound-guided Rhomboid Intercostal Block and Serratus Anterior Plane Block on Postoperative Respiratory Functions and Analgesia After Breast Surgery', 'orgStudyIdInfo': {'id': 'MSK8/22'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Block Group', 'description': 'After endotracheal intubation, patients will be positioned in lateral decubitus position. A linear ultrasound probe will be placed at the edge of scapula at the level of T5-T6. Under sterile conditions, the landmark points (rhomboid major muscle, 5th and 6th ribs, and intercostal muscles) will be observed and a block needle will be directed to the interfacial plane between rhomboid major muscle and intercostal muscle. RIB will be performed by injecting 20 ml of bupivacaine 0.25%. In the same position, the probe will be placed at the midaxillary line at the level of T3, and the landmark points (latissimus dorsi muscle and serratus muscle and intercostal muscles) will be observed. Under sterile conditions, a SAP block will be performed by injecting 20 ml of Bupivacaine 0.25% into the plane between serratus muscle and intercostal muscle.', 'interventionNames': ['Procedure: RIB+SAP blocks']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'No block procedures will be performed in this group.'}], 'interventions': [{'name': 'RIB+SAP blocks', 'type': 'PROCEDURE', 'description': 'RIB block will be performed after endotracheal intubation, then a SAP block will be performed. No other intervention will be performed to the patients.', 'armGroupLabels': ['Block Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48000', 'city': 'Muğla', 'country': 'Turkey (Türkiye)', 'facility': 'Muğla Sıtkı Koçman University', 'geoPoint': {'lat': 37.21807, 'lon': 28.3665}}], 'overallOfficials': [{'name': 'Bakiye Uğur, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Muğla Sıtkı Koçman University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'IPD will not be shared with anyone'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Muğla Sıtkı Koçman University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associated Prof Dr', 'investigatorFullName': 'Başak Altıparmak', 'investigatorAffiliation': 'Muğla Sıtkı Koçman University'}}}}