Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-31 @ 10:24 AM
Study NCT ID:
NCT07426692
Status:
COMPLETED
Last Update Posted:
2026-02-23
First Post:
2026-02-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Erector Spinae Plane Block and Serratus Posterior Superior Intercostal Plane Block for Postoperative Analgesia After Video-Assisted Thoracoscopic Surgery: A Randomized Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D044382', 'term': 'Population Groups'}], 'ancestors': [{'id': 'D003710', 'term': 'Demography'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Postoperative pain assessments were performed by clinicians who were blinded to group allocation in order to minimize assessment bias.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-03-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2025-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-02-15', 'studyFirstSubmitDate': '2026-02-15', 'studyFirstSubmitQcDate': '2026-02-15', 'lastUpdatePostDateStruct': {'date': '2026-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative pain intensity', 'timeFrame': '0 to 48 hours postoperatively', 'description': 'Postoperative pain assessed using the Numeric Rating Scale (NRS, 0-10), where 0 indicates no pain and 10 indicates worst imaginable pain.'}], 'secondaryOutcomes': [{'measure': 'Cumulative morphine consumption', 'timeFrame': '0 to 48 hours postoperatively', 'description': 'Total amount of intravenous morphine administered via patient-controlled analgesia device.'}, {'measure': 'Rescue analgesia requirements', 'timeFrame': '12 hours postoperatively'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postoperative Pain', 'Thoracic Surgery, Video Assisted']}, 'descriptionModule': {'briefSummary': 'This prospective randomized controlled trial was conducted to compare the effectiveness of two ultrasound-guided regional anesthesia techniques, erector spinae plane block (ESPB) and serratus posterior superior intercostal plane block (SPSIPB), with standard patient-controlled analgesia (PCA) for postoperative pain management after video-assisted thoracoscopic surgery (VATS).\n\nAdult patients undergoing elective VATS were randomly assigned to receive ESPB, SPSIPB, or PCA alone. The primary objective was to evaluate postoperative pain intensity during the first 48 hours after surgery. Secondary outcomes included opioid consumption, rescue analgesia requirements, patient satisfaction, and postoperative complications.', 'detailedDescription': 'Video-assisted thoracoscopic surgery (VATS) is a minimally invasive surgical technique; however, postoperative pain remains clinically significant and may delay recovery and increase opioid consumption. Ultrasound-guided fascial plane blocks have been increasingly incorporated into multimodal analgesia strategies in thoracic surgery.\n\nThis single-center, prospective, randomized controlled study included adult patients aged 18-75 years with ASA physical status I-III who were scheduled for elective VATS. After obtaining written informed consent and ethics committee approval, patients were randomly assigned in a parallel design to one of three groups: ESPB group, SPSIPB group, or control group receiving morphine patient-controlled analgesia (PCA) alone.\n\nBoth ESPB and SPSIPB were performed preoperatively under ultrasound guidance by an experienced anesthesiologist prior to induction of general anesthesia. Standardized general anesthesia and postoperative analgesia protocols were applied to all patients.\n\nThe primary outcome was postoperative pain intensity assessed using the Numeric Rating Scale (NRS, 0-10) at predefined time points up to 48 hours postoperatively. Secondary outcomes included cumulative morphine consumption, number of morphine demands, rescue analgesia requirements, patient satisfaction, and opioid-related adverse events.\n\nThe study aimed to determine whether SPSIPB provides analgesic efficacy comparable to ESPB and whether both regional techniques reduce opioid consumption compared with PCA alone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 18 and 75 years\n* American Society of Anesthesiologists (ASA) physical status I-III\n* Scheduled for elective video-assisted thoracoscopic surgery (VATS)\n* Ability to understand and use patient-controlled analgesia device\n* Provided written informed consent\n\nExclusion Criteria:\n\n* \\- Coagulation disorders or current anticoagulant therapy\n* Infection at the block application site\n* Known allergy to local anesthetic agents\n* Anatomical abnormalities interfering with ultrasound-guided block\n* Severe cardiac, renal, or hepatic failure\n* Neurological or cognitive impairment preventing reliable pain assessment\n* Emergency surgery'}, 'identificationModule': {'nctId': 'NCT07426692', 'briefTitle': 'Comparison of Erector Spinae Plane Block and Serratus Posterior Superior Intercostal Plane Block for Postoperative Analgesia After Video-Assisted Thoracoscopic Surgery: A Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'Marmara University'}, 'officialTitle': 'Comparison of Erector Spinae Plane Block and Serratus Posterior Superior Intercostal Plane Block for Postoperative Analgesia After Video-Assisted Thoracoscopic Surgery: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '09.2025.25-0167'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ESPB Group', 'description': 'Patients received ultrasound-guided erector spinae plane block prior to induction of general anesthesia in addition to standard postoperative PCA.', 'interventionNames': ['Procedure: Erector Spinae Plane Block (ESPB) group']}, {'type': 'EXPERIMENTAL', 'label': 'SPSIPB Group', 'description': 'Patients received ultrasound-guided serratus posterior superior intercostal plane block prior to induction of general anesthesia in addition to standard postoperative PCA.', 'interventionNames': ['Procedure: Serratus posterior superior intercostal plane block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PCA Group', 'description': 'Patients received standard postoperative morphine patient-controlled analgesia without regional block.', 'interventionNames': ['Drug: Morfin']}], 'interventions': [{'name': 'Erector Spinae Plane Block (ESPB) group', 'type': 'PROCEDURE', 'description': 'Ultrasound-guided erector spinae plane block performed preoperatively using local anesthetic.', 'armGroupLabels': ['ESPB Group']}, {'name': 'Serratus posterior superior intercostal plane block', 'type': 'PROCEDURE', 'description': 'Ultrasound-guided serratus posterior superior intercostal plane block performed preoperatively using local anesthetic.', 'armGroupLabels': ['SPSIPB Group']}, {'name': 'Morfin', 'type': 'DRUG', 'description': 'Intravenous morphine administered via patient-controlled analgesia device.', 'armGroupLabels': ['PCA Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Marmara University Faculty of Medicine Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Marmara University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'associate professor', 'investigatorFullName': 'Meliha Orhon', 'investigatorAffiliation': 'Marmara University'}}}}