Ignite Creation Date:
2025-12-24 @ 3:22 PM
Ignite Modification Date:
2026-01-29 @ 3:35 AM
Study NCT ID:
NCT07229092
Status:
RECRUITING
Last Update Posted:
2025-11-19
First Post:
2025-11-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Serratus Plane Block and Rhomboid Intercostal Plane Block for Postoperative Analgesia in Breast Reduction Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The patients and the outcome assessor who recorded postoperative pain scores were blinded to the type of block performed'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The study includes two parallel groups. Patients undergoing breast reduction surgery will be randomly assigned to receive either ultrasound-guided serratus plane block (SPB) or rhomboid intercostal plane block (RIPB) for postoperative analgesia.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2025-11-13', 'studyFirstSubmitQcDate': '2025-11-13', 'lastUpdatePostDateStruct': {'date': '2025-11-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-02-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative Pain Score at Rest and During Movement at 1, 6, 12, and 24 Hours', 'timeFrame': '24 hours after surgery', 'description': 'Pain intensity will be assessed using the Numeric Rating Scale (NRS), a 0-10 point scale where 0 = no pain and 10 = worst imaginable pain. Higher scores indicate worse pain. Pain scores will be recorded at rest and during movement at 1, 6, 12, and 24 hours after surgery. All patients will receive intravenous patient-controlled analgesia (PCA) for postoperative pain management.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postoperative Analgesia in Breast Reduction Surgery', 'Postoperative Pain', 'Postoperative Pain Breast Reduction', 'Pain, Postoperative']}, 'descriptionModule': {'briefSummary': 'This prospective, randomized clinical study aims to compare the analgesic efficacy of serratus plane block (SPB) and rhomboid intercostal plane block (RIPB) for postoperative analgesia in patients undergoing elective bilateral breast reduction surgery under general anesthesia. All patients will receive standardized general anesthesia. Before induction of anesthesia, while patients are awake, Group SPB will receive an ultrasound-guided serratus anterior plane block and Group RIPB will receive an ultrasound-guided rhomboid intercostal plane block. Postoperative analgesia will be maintained with intravenous patient-controlled analgesia (PCA) with opioids. Primary outcomes include postoperative pain scores and opioid consumption at 1, 6, 12, and 24 hours. Secondary outcomes include time to first analgesic demand, patient satisfaction, and block-related complications.', 'detailedDescription': 'Postoperative pain management in breast reduction surgery is challenging due to wide tissue dissection and thoracic wall involvement. Serratus plane block (SPB) and rhomboid intercostal plane block (RIPB) are regional anesthesia techniques that provide analgesia by blocking the lateral cutaneous branches of the intercostal nerves.\n\nThis randomized controlled trial will compare the analgesic efficacy of SPB and RIPB in female patients aged 18-65 undergoing elective bilateral breast reduction surgery under general anesthesia.\n\nBefore induction of general anesthesia, while patients are awake, ultrasound-guided SPB or RIPB will be performed according to group allocation. After block performance, general anesthesia will be induced using a standardized protocol. Postoperative pain management will be provided with intravenous patient-controlled analgesia (PCA) with opioids.\n\nPrimary outcomes include postoperative pain scores (NRS) and opioid consumption. Secondary outcomes include duration of analgesia, time to first analgesic request, patient satisfaction, and block-related complications. The hypothesis is that both blocks will reduce postoperative pain and opioid consumption, but the duration and quality of analgesia may differ between SPB and RIPB.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Only biologically female patients undergoing elective breast reduction surgery will be eligible to participate in this study', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female patients aged 18-65 years\n\nAmerican Society of Anesthesiologists (ASA) physical status I-II\n\nScheduled for elective bilateral breast reduction surgery under general anesthesia\n\nWilling and able to provide written informed consent\n\nExclusion Criteria:\n\n* Allergy or contraindication to local anesthetics (bupivacaine)\n\nCoagulopathy or anticoagulant medication use\n\nInfection at or near the injection site\n\nHistory of chronic opioid use or psychiatric/neurological disorders affecting pain perception\n\nBody mass index (BMI) \\> 35 kg/m²\n\nRefusal to participate in the study'}, 'identificationModule': {'nctId': 'NCT07229092', 'acronym': 'SAPB-RIPB', 'briefTitle': 'Comparison of Serratus Plane Block and Rhomboid Intercostal Plane Block for Postoperative Analgesia in Breast Reduction Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Aydin Adnan Menderes University'}, 'officialTitle': 'Comparison of Serratus Plane Block and Rhomboid Intercostal Plane Block for Postoperative Analgesia in Patients Undergoing Breast Reduction Surgery: A Randomized Clinical Study', 'orgStudyIdInfo': {'id': 'ADU-SAPB-RIPB-2025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Serratus Plane Block', 'description': '"Patients in this group will receive an ultrasound-guided serratus anterior plane block (SAPB) before induction of general anesthesia, while awake. A total of 30 mL of local anesthetic solution (5 mL normal saline, 5 mL of 2% lidocaine, and 20 mL of 0.25% bupivacaine) will be prepared. The total solution will be divided equally between both breasts, with 15 mL administered to the right side and 15 mL to the left side. Each side will receive a single injection point along the midaxillary line to provide adequate spread within the serratus plane.', 'interventionNames': ['Procedure: Serratus Plane Block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Rhomboid Intercostal Plane Block', 'description': '"Patients in this group will receive an ultrasound-guided rhomboid intercostal plane block (RIPB) before induction of general anesthesia, while awake. A total of 30 mL of local anesthetic solution (5 mL normal saline, 5 mL of 2% lidocaine, and 20 mL of 0.25% bupivacaine) will be prepared. The total solution will be divided equally between both breasts, with 15 mL administered on the right and 15 mL on the left. Each side will receive a single injection point beneath the medial border of the scapula at the level of the intercostal plane to ensure adequate spread between the rhomboid major muscle and intercostal muscles."', 'interventionNames': ['Procedure: Rhomboid Intercostal Plane Block (RIPB)']}, {'type': 'OTHER', 'label': 'Control Group (No Block)', 'description': 'Patients in this group will not receive any regional block. Standard general anesthesia and multimodal postoperative analgesia will be provided according to institutional protocol', 'interventionNames': ['Other: No Regional Block (Control)']}], 'interventions': [{'name': 'Serratus Plane Block', 'type': 'PROCEDURE', 'description': '"Ultrasound-guided serratus anterior plane block performed preoperatively while patients are awake. A total of 30 mL of local anesthetic solution (5 mL saline, 5 mL of 2% lidocaine, 20 mL of 0.25% bupivacaine) will be used. The total volume will be divided equally between both breasts (15 mL per side), with one injection point on each side at the midaxillary line', 'armGroupLabels': ['Serratus Plane Block']}, {'name': 'Rhomboid Intercostal Plane Block (RIPB)', 'type': 'PROCEDURE', 'description': 'Ultrasound-guided rhomboid intercostal plane block (RIPB) performed preoperatively while patients are awake, using a total of 30 mL local anesthetic solution (5 mL normal saline, 5 mL of 2% lidocaine, and 20 mL of 0.25% bupivacaine). The total volume will be divided equally between both breasts (15 mL per side), with one injection point on each side between the rhomboid major muscle and the intercostal muscles at the medial border of the scapula around the 5th intercostal level.', 'armGroupLabels': ['Rhomboid Intercostal Plane Block']}, {'name': 'No Regional Block (Control)', 'type': 'OTHER', 'description': 'Participants in this group will not receive any regional block. Standard general anesthesia and multimodal postoperative analgesia will be provided according to institutional protocol.', 'armGroupLabels': ['Control Group (No Block)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '09010', 'city': 'Aydin', 'state': 'Aydın', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'facility': 'Aydın Adnan Menderes University Hospital, Department of Anesthesiology and Reanimation', 'geoPoint': {'lat': 37.84501, 'lon': 27.83963}}], 'centralContacts': [{'name': 'konul karaja, MD', 'role': 'CONTACT', 'email': 'konul2992@gmail.com', 'phone': '+905550948199'}, {'name': 'kamil Varlık Erel, prof', 'role': 'CONTACT', 'email': 'varlık.erel@gmail.com', 'phone': '+905324439202'}], 'overallOfficials': [{'name': 'Konul karaja, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aydın Adnan Menderes University Hospita'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Konul Karaja', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Anesthesiology Research Fellow / MD', 'investigatorFullName': 'Konul Karaja', 'investigatorAffiliation': 'Aydin Adnan Menderes University'}}}}