Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2026-01-01 @ 6:30 PM
Study NCT ID:
NCT07011069
Status:
RECRUITING
Last Update Posted:
2025-06-08
First Post:
2025-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rhomboid Intercostal and Subserratus Plane Block vs Erector Spinae Plane Block in Video-Assisted Thoracoscopic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-04', 'studyFirstSubmitDate': '2025-05-23', 'studyFirstSubmitQcDate': '2025-06-04', 'lastUpdatePostDateStruct': {'date': '2025-06-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Opioid consumption', 'timeFrame': 'Postoperative first 24 hours.', 'description': 'Total opioid consumption within the first 24 hours in the postoperative period.'}], 'secondaryOutcomes': [{'measure': 'Dynamic pain score', 'timeFrame': 'Postoperative first 24 hours.', 'description': 'Postoperative pain scores during coughing and deep breathing are measured on a 10 cm scale, where "0" indicates no pain and "10" indicates the worst pain ever.'}, {'measure': 'Resting pain score', 'timeFrame': 'Postoperative first 24 hours.', 'description': 'Postoperative pain scores during rest are measured on a 10 cm scale, where "0" indicates no pain and "10" indicates the worst pain ever.'}, {'measure': 'Pulmonary functions', 'timeFrame': 'Postoperative first 24 hours.', 'description': 'Pulmonary functions are assessed using Triflow performance. Postoperative Triflow numbers (whether 1, 2, or 3 balls can be raised) for the patients are recorded.'}, {'measure': 'Complications', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Complications regarding regional blocks and surgery (such as hematoma, pulmonary complications) are recorded.'}, {'measure': 'Hospital stay time', 'timeFrame': 'Perioperatively', 'description': 'The length of hospital stay is recorded.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Video Assisted Thoracoscopic Surgery', 'Regional Block for Pain Control', 'Regional Blocks', 'Pulmonary Functions']}, 'referencesModule': {'references': [{'pmid': '28919152', 'type': 'BACKGROUND', 'citation': 'Forero M, Rajarathinam M, Adhikary S, Chin KJ. Erector spinae plane (ESP) block in the management of post thoracotomy pain syndrome: A case series. Scand J Pain. 2017 Oct;17:325-329. doi: 10.1016/j.sjpain.2017.08.013. Epub 2017 Sep 12.'}, {'pmid': '30169476', 'type': 'BACKGROUND', 'citation': 'Elsharkawy H, Maniker R, Bolash R, Kalasbail P, Drake RL, Elkassabany N. Rhomboid Intercostal and Subserratus Plane Block: A Cadaveric and Clinical Evaluation. Reg Anesth Pain Med. 2018 Oct;43(7):745-751. doi: 10.1097/AAP.0000000000000824.'}, {'pmid': '28149550', 'type': 'BACKGROUND', 'citation': 'Hsieh MJ, Wang KC, Liu HP, Gonzalez-Rivas D, Wu CY, Liu YH, Wu YC, Chao YK, Wu CF. Management of acute postoperative pain with continuous intercostal nerve block after single port video-assisted thoracoscopic anatomic resection. J Thorac Dis. 2016 Dec;8(12):3563-3571. doi: 10.21037/jtd.2016.12.30.'}]}, 'descriptionModule': {'briefSummary': 'To compare the rhomboid intercostal subserratus plane block with the erector spinae plane block regarding their analgesic efficacy and effects on respiratory function for patients undergoing video-assisted thoracoscopic surgery.', 'detailedDescription': 'Video-assisted thoracoscopic surgery (VATS) can be very painful and may lead to complications such as prolonged stays in intensive care, thromboembolic complications due to lack of early mobilization, chronic acute pain, and delirium if adequate analgesia is not provided. Therefore, using thoracic epidural, paravertebral, or regional blocks as part of multimodal analgesia is recommended to provide effective pain relief.\n\nThis study aims to compare the effects of the erector spinae plane block (ESP) and rhomboid intercostal subserratus plane block (RISS) on postoperative analgesia and the improvement of respiratory parameters in patients undergoing VATS.\n\nThe primary objective is to evaluate total analgesic consumption in the first 24 hours postoperatively. Secondary objectives include assessing active and dynamic pain scores, triflow performance, complications, and the length of hospital stays.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who will undergo VATS\n* Who agrees to participate\n* American Society of Anesthesiologists (ASA) physical status I, II, and III\n* Elective surgery\n* Age between 18 and 80 years\n\nExclusion Criteria:\n\n* Local anesthetic allergy\n* Who disagrees to participate\n* ASA physical status IV and V\n* Emergency surgery\n* Hemorrhagic disease\n* Thoracic vertebrae deformity\n* Thoracic vertebrae surgery'}, 'identificationModule': {'nctId': 'NCT07011069', 'briefTitle': 'Rhomboid Intercostal and Subserratus Plane Block vs Erector Spinae Plane Block in Video-Assisted Thoracoscopic Surgery', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Bursa City Hospital'}, 'officialTitle': 'Comparison of the Efficacy of Rhomboid Intercostal and Subserratus Plane Block (RISS) Versus Erector Spinae Plane (ESP) Blocks in Video-Assisted Thoracoscopic Surgery (VATS) for Postoperative Pain Management and Respiratory Function', 'orgStudyIdInfo': {'id': '2024-11/4 24-AKD-209'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Patients who received ESP block', 'description': 'Those who received the erector spinae plane block for postoperative pain management', 'interventionNames': ['Procedure: ESP block group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Patients who received RISS block', 'description': 'Those who received the rhomboid intercostal subserratus plane block for postoperative pain management', 'interventionNames': ['Procedure: RISS block group']}], 'interventions': [{'name': 'ESP block group', 'type': 'PROCEDURE', 'description': 'ESP blocks are performed for patients undergoing VATS.', 'armGroupLabels': ['Patients who received ESP block']}, {'name': 'RISS block group', 'type': 'PROCEDURE', 'description': 'RISS blocks are performed for patients undergoing VATS.', 'armGroupLabels': ['Patients who received RISS block']}]}, 'contactsLocationsModule': {'locations': [{'zip': '16110', 'city': 'Bursa', 'state': 'Nilufer', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Hande Gurbuz', 'role': 'CONTACT', 'email': 'handegrbz@gmail.com', 'phone': '+905336515650'}, {'role': 'CONTACT', 'email': 'handegrbz@gmail.com'}, {'name': 'Hande Gurbuz, Assoc Prof, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Yusuf Alan, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University of Health Sciences, Bursa City Hospital', 'geoPoint': {'lat': 40.19559, 'lon': 29.06013}}], 'centralContacts': [{'name': 'Hande Gurbuz, Assoc Prof, MD, PhD', 'role': 'CONTACT', 'email': 'handegrbz@gmail.com', 'phone': '+905336515650'}, {'name': 'Yusuf Alan, MD', 'role': 'CONTACT', 'email': 'dryusufalan@gmail.com', 'phone': '+90 539 621 09 77'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': '2026 to 2027', 'ipdSharing': 'YES', 'description': 'The data sets used in this research may be made available upon reasonable request to the corresponding author.', 'accessCriteria': 'The data sets used in this research may be made available upon reasonable request to the corresponding author.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bursa City Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoc. Prof., MD, PhD', 'investigatorFullName': 'Hande Gurbuz', 'investigatorAffiliation': 'Bursa City Hospital'}}}}