Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 2:23 AM
Study NCT ID:
NCT07394868
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-11
First Post:
2026-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of the Combined Serratus Anterior Plane Block Versus Superficial Serratus Anterior Plane Block
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-08-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-07', 'studyFirstSubmitDate': '2026-01-31', 'studyFirstSubmitQcDate': '2026-01-31', 'lastUpdatePostDateStruct': {'date': '2026-02-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Opioid consumption', 'timeFrame': '24 hours postoperative', 'description': 'Patients will be monitored for 24-hour opioid consumption with patient-controlled analgesia.'}], 'secondaryOutcomes': [{'measure': 'Numeric Rating Scale (NRS)', 'timeFrame': '1 hour', 'description': 'NRS is a scoring system ranging from 0 to 10, where higher values indicate a higher degree of pain.\n\nPain level assessed by Numeric Rating Scale (NRS) in the first 24 hours postoperatively, pain at 1 hour, 2, 4, 12, and 24 hours, and pain with rest and coughing.'}, {'measure': 'Numeric Rating Scale (NRS)', 'timeFrame': '2 hour', 'description': 'NRS is a scoring system ranging from 0 to 10, where higher values indicate a higher degree of pain.\n\nPain level assessed by Numeric Rating Scale (NRS) in the first 24 hours postoperatively, pain at 1 hour, 2, 4, 12, and 24 hours, and pain with rest and coughing.'}, {'measure': 'Numeric Rating Scale (NRS)', 'timeFrame': '4 hour', 'description': 'NRS is a scoring system ranging from 0 to 10, where higher values indicate a higher degree of pain.\n\nPain level assessed by Numeric Rating Scale (NRS) in the first 24 hours postoperatively, pain at 1 hour, 2, 4, 12, and 24 hours, and pain with rest and coughing.'}, {'measure': 'Numeric Rating Scale (NRS)', 'timeFrame': '12 hour', 'description': 'NRS is a scoring system ranging from 0 to 10, where higher values indicate a higher degree of pain.\n\nPain level assessed by Numeric Rating Scale (NRS) in the first 24 hours postoperatively, pain at 1 hour, 2, 4, 12, and 24 hours, and pain with rest and coughing.'}, {'measure': 'Numeric Rating Scale (NRS)', 'timeFrame': '24 hour', 'description': 'NRS is a scoring system ranging from 0 to 10, where higher values indicate a higher degree of pain.\n\nPain level assessed by Numeric Rating Scale (NRS) in the first 24 hours postoperatively, pain at 1 hour, 2, 4, 12, and 24 hours, and pain with rest and coughing.'}, {'measure': 'Patient satisfaction score', 'timeFrame': '24 hour', 'description': 'Patient satisfaction will be evaluated using a 5-point Likert scale at 24 hours postoperatively.\n\nA Likert scale is a system of scores ranging from 1 to 5, where 1 (not satisfied at all) and 5 (very satisfied).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Breast surgery', 'Multimodal analgesia', 'Serratus anterior plane block'], 'conditions': ['Pain']}, 'referencesModule': {'references': [{'pmid': '36484891', 'type': 'BACKGROUND', 'citation': 'Chai B, Wang Q, Du J, Chen T, Qian Y, Zhu Z, Feng Z, Kang X. Research Progress on Serratus Anterior Plane Block in Breast Surgery: A Narrative Review. Pain Ther. 2023 Apr;12(2):323-337. doi: 10.1007/s40122-022-00456-z. Epub 2022 Dec 9.'}, {'pmid': '40721998', 'type': 'RESULT', 'citation': 'Ozguner Y, Yazar CO, Aydin F, Zengin M, Arik E, Kotanoglu MS, Altinsoy S, Ergil J. Comparison of the analgesic efficacy of combined superficial and deep serratus anterior plane block versus pectoserratus plane block following modified radical mastectomy surgery. BMC Anesthesiol. 2025 Jul 28;25(1):358. doi: 10.1186/s12871-025-03213-9.'}, {'pmid': '39473759', 'type': 'RESULT', 'citation': 'Ulger G, Zengin M, Kucuk O, Baldemir R, Kaybal O, Tunc M, Sazak H, Alagoz A. Comparison of combined deep and superficial serratus anterior block with thoracic paravertebral block for postoperative pain in patients undergoing video-assisted thoracoscopic surgery. Turk J Med Sci. 2024 Aug 4;54(5):1021-1032. doi: 10.55730/1300-0144.5881. eCollection 2024.'}]}, 'descriptionModule': {'briefSummary': 'Breast cancer is the most common malignancy in women; surgery is a cornerstone of breast cancer treatment, and modified radical mastectomy is one of the standard treatments. Postoperative pain can significantly reduce the quality of life in patients, and acute pain can even trigger chronic pain syndrome. Thoracic paravertebral, thoracic epidural, intercostal nerve, and interscalene brachial plexus blocks have been used for anesthesia and abiration during modified radical mastectomy, but their application is limited due to the complex nature of the procedures and serious complications. In recent years, there has been increasing interest in the newer, less invasive superficial serratus block and combined serratus block. Serratus anterior plane block (SAPB) can be applied in two ways. Deep SPB (DSPB) is applied under the serratus anterior muscle, while superficial SPB (YSPB) is applied above the serratus anterior muscle. In recent years, deep + superficial SPB, or combined SPB (KSPB), has begun to be applied in order to increase the area of effect of local anesthetics and to prevent block failure. This study aims to compare superficial and combined serratus anterior plane blocks.', 'detailedDescription': 'Breast cancer is the most common malignancy in women; surgery is a cornerstone of breast cancer treatment, and modified radical mastectomy is one of the standard treatments. Postoperative pain can significantly reduce the quality of life in patients, and acute pain can even trigger chronic pain syndrome. Thoracic paravertebral, thoracic epidural, intercostal nerve, and interscalene brachial plexus blocks have been used for anesthesia and abiration during modified radical mastectomy, but their application is limited due to the complex nature of the procedures and serious complications. In recent years, there has been increasing interest in the newer, less invasive superficial serratus block and combined serratus block. Serratus anterior plane block (SAPB) can be applied in two ways. Deep SPB (DSPB) is applied under the serratus anterior muscle, while superficial SPB (YSPB) is applied above the serratus anterior muscle. In recent years, deep + superficial SPB, or combined SPB (KSPB), has begun to be applied in order to increase the area of effect of local anesthetics and to prevent block failure. This study aims to compare superficial and combined serratus anterior plane blocks. Superficial serratus anterior plane block procedure: The USG probe is placed on the 4th rib in the mid-axillary line. After visualizing the muscle structures up to the rib (latissimus dorsi, teres major, and serratus anterior), the needle is advanced using the in-plane technique to the serratus anterior muscle, under the latissimus dorsi muscle, and hydrodissection is performed with 2 ml of saline to ensure positional accuracy. Then, 15 ml of 0.25% bupivacaine is injected into this area. KSAB procedure: The USG probe is placed on the 4th rib in the mid-axillary line. After visualizing the muscle structures up to the rib (latissimus dorsi, teres major, and serratus anterior), the needle is advanced using the in-plane technique to the 4th rib, under the serratus anterior muscle, and onto the rib. Hydrodissection is performed with 2 ml of saline to ensure positional accuracy. Then, 15 ml of 0.25% bupivacaine is injected into this area. The needle is then withdrawn 1-2 cm and positioned over the serratus anterior muscle, below the latissimus dorsi muscle. Hydrodissection with 2 ml of saline is performed to ensure accuracy. Then, 15 ml of 0.25% bupivacaine is injected into this area. A total of 30 ml of bupivacaine will be injected, and the procedure will be terminated. In our clinic, multimodal analgesia is preferred for patients undergoing mastectomy. Peripheral nerve blocks (for all suitable and consenting patients) are used in conjunction with intravenous analgesic agents. Both block types are routinely applied in suitable patients who have undergone mastectomy.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who undergone mastectomy surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individuals aged 18-80 years\n* Individuals with ASA scores I-II-III\n* Individuals with a Body Mass Index (BMI) between 18-40\n\nExclusion Criteria:\n\n* Individuals under 18 years of age and over 80 years of age\n* Individuals with an ASA score of IV or higher\n* Individuals with advanced comorbidities\n* Individuals with a history of bleeding diathesis\n* Patients with infection in the area to be blocked\n* Individuals with a BMI below 18 and above 40'}, 'identificationModule': {'nctId': 'NCT07394868', 'briefTitle': 'Comparison of the Combined Serratus Anterior Plane Block Versus Superficial Serratus Anterior Plane Block', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Ankara Etlik City Hospital'}, 'officialTitle': 'Comparison of the Analgesic Efficacy of Combined Superficial and Deep Serratus Anterior Plane Block Versus Superficial Serratus Anterior Plane Block Following Modified Radical Mastectomy Surgery', 'orgStudyIdInfo': {'id': 'Etlik Kübra Tez'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Combined superficial and deep serratus anterior plane block', 'description': 'Patients who will undergo combined serratus anterior plane block will be included in this group.', 'interventionNames': ['Other: Combined serratus plan block']}, {'label': 'Superficial serratus anterior plane block', 'description': 'Patients who will undergo a superficial anterior plane serratus block will be included in this group.', 'interventionNames': ['Other: Superficial serratus plane block']}], 'interventions': [{'name': 'Combined serratus plan block', 'type': 'OTHER', 'description': 'Combined serratus plan block', 'armGroupLabels': ['Combined superficial and deep serratus anterior plane block']}, {'name': 'Superficial serratus plane block', 'type': 'OTHER', 'description': 'Superficial serratus plane block', 'armGroupLabels': ['Superficial serratus anterior plane block']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06170', 'city': 'Ankara', 'state': 'Varlık Mahallesi, Halil Sezai Erkut Caddesi Yenimahalle', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Yusuf Ozguner', 'role': 'CONTACT', 'email': 'etliksh.iletisim@saglik.gov.tr', 'phone': '+903127970000'}], 'facility': 'Ankara Etlik City Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'centralContacts': [{'name': 'Yusuf Ozguner', 'role': 'CONTACT', 'email': 'y.ozguner@hotmail.com', 'phone': '05427150725'}], 'overallOfficials': [{'name': 'Yusuf Ozguner', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ankara Etlik City Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara Etlik City Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Yusuf Özgüner', 'investigatorAffiliation': 'Ankara Etlik City Hospital'}}}}