Ignite Creation Date:
2025-12-24 @ 5:05 PM
Ignite Modification Date:
2026-01-09 @ 5:25 PM
Study NCT ID:
NCT04752150
Status:
COMPLETED
Last Update Posted:
2022-01-21
First Post:
2021-02-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ESPB and RIB for Pain Management Following Mastectomy Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The anesthesiologist who performs postoperative pain evaluation and the patient will not know the group.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'There are two models for this study. The first group is ESPB group. The second one is RIB group'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2021-12-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-20', 'studyFirstSubmitDate': '2021-02-01', 'studyFirstSubmitQcDate': '2021-02-08', 'lastUpdatePostDateStruct': {'date': '2022-01-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain scores (Visual analogue scores-VAS)', 'timeFrame': 'Changes from baseline pain scores at postoperative 1, 2, 4, 8, 16, and 24 hours.', 'description': 'The primary aim is to compare VAS. Postoperative pain assessment will be performed using the VAS score (0 = no pain, 10 = the most severe pain felt). The VAS scores will be recorded'}], 'secondaryOutcomes': [{'measure': 'Opioid consumption', 'timeFrame': 'Change from baseline opioid consumption at postoperative 1, 2, 4, 8, 16, and 24 hours', 'description': 'The secondary aim is to compare postoperative opioid consumption'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mastectomy and axillary dissection surgery', 'Postoperative pain management', 'Rhomboid intercostal block', 'Erector spina plane block'], 'conditions': ['Breast Cancer', 'Breast Neoplasms', 'Breast Cancer Female']}, 'referencesModule': {'references': [{'pmid': '27501016', 'type': 'BACKGROUND', 'citation': 'Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.'}, {'pmid': '31122843', 'type': 'BACKGROUND', 'citation': 'Ciftci B, Ekinci M, Celik EC, Tukac IC, Bayrak Y, Atalay YO. Efficacy of an Ultrasound-Guided Erector Spinae Plane Block for Postoperative Analgesia Management After Video-Assisted Thoracic Surgery: A Prospective Randomized Study. J Cardiothorac Vasc Anesth. 2020 Feb;34(2):444-449. doi: 10.1053/j.jvca.2019.04.026. Epub 2019 Apr 30.'}, {'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.'}, {'pmid': '27291611', 'type': 'BACKGROUND', 'citation': 'Elsharkawy H, Saifullah T, Kolli S, Drake R. Rhomboid intercostal block. Anaesthesia. 2016 Jul;71(7):856-7. doi: 10.1111/anae.13498. No abstract available.'}, {'pmid': '32079739', 'type': 'BACKGROUND', 'citation': 'Altiparmak B, Korkmaz Toker M, Uysal AI, Dere O, Ugur B. Evaluation of ultrasound-guided rhomboid intercostal nerve block for postoperative analgesia in breast cancer surgery: a prospective, randomized controlled trial. Reg Anesth Pain Med. 2020 Apr;45(4):277-282. doi: 10.1136/rapm-2019-101114. Epub 2020 Feb 19.'}]}, 'descriptionModule': {'briefSummary': 'Postoperative pain is an important issue in patients underwent mastectomy and axillary dissection surgery. Postoperative effective pain treatment provides early mobilization and shorter hospital stay. The US-guided erector spina plane block (ESPB) may be used for postoperative pain treatment following breast surgery. It is a novel interfascial block that was defined by Forero. Rhomboid intercostal block (RIB) is a novel block and was first described by Elsharkawy et al. Local anesthetic solution is administrated between the rhomboid muscle and intercostal muscles over the T5-6 ribs. It has been reported that RIB may provide effective analgesia management for several breast surgeries.\n\nThe primary aim of the study is to compare postoperative pain scores (VAS), and the secondary aim is to evaluate postoperative opioid consumption, adverse effects related with opioids (allergic reaction, nausea, vomiting).', 'detailedDescription': 'Postoperative pain is an important issue in patients underwent mastectomy and axillary dissection surgery. Postoperative effective pain treatment provides early mobilization and shorter hospital stay, thus complications due to hospitalization such as infection and thromboembolism may be reduced.\n\nVarious methods may be performed to reduce the use of systemic opioids and for effective pain treatment following mastectomy and axillary dissection surgery. Ultrasound (US)-guided interfascial plane blocks have been used increasingly due to the advantages of ultrasound in anesthesia practice. Rhomboid intercostal block (RIB) is a novel block and was first described by Elsharkawy et al. Local anesthetic solution is administrated between the rhomboid muscle and intercostal muscles over the T5-6 ribs 2-3 cm medially of the medial border of the scapula. RIB targets both the posterior rami and lateral cutaneous branches of the thoracic nerves and provides analgesia for the hemithorax from T2 to T9. It has been reported that RIB may provide effective analgesia management for several breast surgeries.\n\nThe US-guided erector spina plane block (ESPB) is defined by Forero et al. ESPB provides thoracic analgesia at T5 level and abdominal analgesia at T7-9 level. ESPB contains a local anesthetic injection into the deep fascia of erector spinae. Visualization of sonoanatomy is easy, and the spread of local anesthesic agents can be easily seen under the erector spinae muscle. Thus, analgesia occurs in several dermatomes with cephalad-caudad way. In the literature, it has been reported that ESP block provides effective analgesia after several surgeries such as open heart surgery, breast surgery, thoracoscopic and abdominal operations.\n\nThe aim of this study is to evaluate the efficacy of the US-guided ESPB and RIB for postoperative analgesia after mastectomy and axillary dissection surgery. The primary aim is to compare postoperative pain scores (VAS), and the secondary aim is to evaluate opioid consumption, adverse effects related with opioids (allergic reaction, nausea, vomiting).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Female patients who will undergo breast surgery will be included', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American Society of Anesthesiologists (ASA) classification I-II\n* Scheduled for mastectomy and axillary dissection surgery under general anesthesia\n\nExclusion Criteria:\n\n* receiving anticoagulant treatment,\n* known study drugs allergy,\n* opioid addiction\n* infection of the skin at the site of the block,\n* pregnancy or lactation,'}, 'identificationModule': {'nctId': 'NCT04752150', 'briefTitle': 'ESPB and RIB for Pain Management Following Mastectomy Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Medipol University'}, 'officialTitle': 'Comparison of Ultrasound-Guided Erector Spinae Plane Block and Rhomboid Intercostal Block for Pain Management Following Mastectomy Surgery', 'orgStudyIdInfo': {'id': 'Medipol Hospital 18'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group ESPB = Erector spinae plane block group', 'description': 'In group ESPB, ESPB will be performed with patients in the lateral decubitus position while the surgical site up. US probe will be placed 2-3 cm lateral to the T4 transvers process. The block needle will be inserted cranio-caudal direction and then for correction of the needle 5 ml saline will be injected deep into the erector spina muscle fascia. Following confirmation of the correct position of the needle 30 ml %0.25 bupivacaine will be administered for block.', 'interventionNames': ['Other: Analgesia management; group ESPB and RIB']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group RIB = RIB group', 'description': 'In group RIB, RIB block will be performed with patients in the lateral decubitus position while the surgical site up. The linear high frequency probe will be placed in sagittal plane medially on the medial border of the scapula at T5-6 level. The trapezius muscle, rhomboid major muscle, intercostal muscle, ribs and the pleura will be visualized. The needle will be inserted into the fascial plane between the rhomboid major and intercostal muscles in a cranio-caudal direction. A dose of 30 ml 0,25% bupivacaine will be injectted into the fascial plane.', 'interventionNames': ['Other: Analgesia management; group ESPB and RIB']}], 'interventions': [{'name': 'Analgesia management; group ESPB and RIB', 'type': 'OTHER', 'description': 'Patients will be administered ibuprofen 400 mgr IV every 8 hours in the postoperative period. A patient controlled device prepared with 10 mcg/ ml fentanyl will be attached to all patients with a protocol included 10 mcg bolus without infusion dose, 10 min lockout time and 4 hour limit. Postoperative patient evaluation will be performed by an anesthesiologist blinded to the procedure.', 'armGroupLabels': ['Group ESPB = Erector spinae plane block group', 'Group RIB = RIB group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34070', 'city': 'Istanbul', 'state': 'Bagcilar', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul Medipol University Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'We will not plan to share IPD'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medipol University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Primary researcher', 'investigatorFullName': 'Bahadir Ciftci', 'investigatorAffiliation': 'Medipol University'}}}}