Ignite Creation Date:
2025-12-24 @ 12:47 PM
Ignite Modification Date:
2025-12-27 @ 9:42 PM
Study NCT ID:
NCT05160961
Status:
UNKNOWN
Last Update Posted:
2023-08-29
First Post:
2021-12-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
US-Guided SAPB Versus ESPB on Acute and Chronic Pain After VATS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D059787', 'term': 'Acute Pain'}, {'id': 'D059350', 'term': 'Chronic Pain'}], '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': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-12-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2024-07-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-08-28', 'studyFirstSubmitDate': '2021-12-03', 'studyFirstSubmitQcDate': '2021-12-15', 'lastUpdatePostDateStruct': {'date': '2023-08-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain scores', 'timeFrame': 'First 24 hours after surgery', 'description': 'Pain will be assessed at rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain). Pain assessment will be done at 1st, 2nd, 4th, 8th, 16th and 24th hours after surgery.'}], 'secondaryOutcomes': [{'measure': 'Chronic pain', 'timeFrame': '3rd month and 6th month', 'description': 'Chronic pain findings will be evaluated in the 3rd month and 6th month after surgery by using visual analog from 0 (no pain) to 10 (worst pain). Neuropathic pain symptoms (Burning, stabbing, or electric shock-like pain; tingling, numbness, or a "pins and needles" feeling, hyperalgesia, allodynia and hypoesthesia) will also be asked to the participants in the 3rd month and 6th month after surgery.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Serratus anterior plane block', 'Erector spinae plane block', 'Acute Pain', 'Chronic Pain'], 'conditions': ['Postoperative Pain', 'Video-Assisted Thoracoscopic Surgery', 'Serratus Anterior Plane Block', 'Erector Spinae Plane Block', 'Acute Pain', 'Chronic Pain']}, 'descriptionModule': {'briefSummary': 'Postoperative acute and chronic pain is frequently observed in patients undergoing video assisted thoracoscopic surgery (VATS). This prolongs the discharge time of patients and increases the frequency of postoperative pulmonary complications. Recently, alternative analgesic methods such as thoracic paravertebral block (TPVB), erector spinae plane block (ESPB), and serratus anterior plane block (SAPB) which are thought to have less side effects than thoracic epidural analgesia, have been used. Among these methods, ultrasound (US) guided TPVB is the most preferred method. In addition, ESPB and SAPB application is increasing in patients undergoing VATS. In the literature, the number of cases performed with ESPB and SAPB and randomized controlled prospective studies with ESPB and SAPB are increasing. In this study, it is planned to compare the effects of US-guided SAPB and ESPB on postoperative acute and chronic pain in patients undergoing VATS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 18 and 65 years\n* American Society of Anesthesiologists physical status I-II-III\n* Body mass index between 18-30 kg/m2\n* Patients undergoing elective video assiste thoracoscopic surgery\n\nExclusion Criteria:\n\n* Advanced cancer\n* History of chronic analgesic therapy\n* History of local anesthetic allergy\n* Infection in the intervention area\n* Patients with bleeding disorders'}, 'identificationModule': {'nctId': 'NCT05160961', 'briefTitle': 'US-Guided SAPB Versus ESPB on Acute and Chronic Pain After VATS', 'organization': {'class': 'OTHER', 'fullName': 'Atatürk Chest Diseases and Chest Surgery Training and Research Hospital'}, 'officialTitle': 'Comparison of the Effects of Ultrasound-guided Serratus Anterior Plane Block and Erector Spinae Plane Block on Postoperative Acute and Chronic Pain for Patients Who Underwent Video-assisted Thoracoscopic Surgery.', 'orgStudyIdInfo': {'id': 'E.Kurul-E1-21-2142'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Serratus Anterior Plane Block', 'description': 'Following the visualization of the anatomical structures, the nerve block needle will be advanced via the in-plane technique beneath the serratus anterior muscles until the interfascial space was reached. After hydrodissection with 2 ml normal saline, 20 ml 0.25% bupivacaine will be injected into the area.', 'interventionNames': ['Procedure: Serratus anterior plane block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Erector spinae plane block', 'description': 'After the linear ultrasound (US) probe will be placed 2-3 cm lateral to the T5 spinous process, 20 ml of 0.25% bupivacaine hydrochloride will be injected into the interfacial space below the erector spinae muscle, above the transverse process.', 'interventionNames': ['Procedure: Erector spinae plane block']}], 'interventions': [{'name': 'Serratus anterior plane block', 'type': 'PROCEDURE', 'otherNames': ['Drug'], 'description': 'Serratus anterior plane block will be performed unilaterally, under US guidance, before the surgical operation, after the induction of anesthesia, when the patient is placed in the lateral decubitus position.', 'armGroupLabels': ['Serratus Anterior Plane Block']}, {'name': 'Erector spinae plane block', 'type': 'PROCEDURE', 'otherNames': ['Drug'], 'description': 'Erector spinae plane block will be performed unilaterally, under US guidance, before the surgical operation, after the induction of anesthesia, when the patient is placed in the lateral decubitus position.', 'armGroupLabels': ['Erector spinae plane block']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06000', 'city': 'Keçiören', 'state': 'Ankara', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Musa Zengin, MD', 'role': 'CONTACT', 'email': 'musazengin@gmail.com', 'phone': '+903125677233'}], 'facility': 'Ankara Atatürk Chest Disease and Chest Surgery Training and Research Hospital', 'geoPoint': {'lat': 40.00132, 'lon': 32.87238}}], 'centralContacts': [{'name': 'Musa Zengin, MD', 'role': 'CONTACT', 'email': 'musazengin@gmail.com', 'phone': '903125677233'}, {'name': 'Ali Alagoz, Assoc Prof', 'role': 'CONTACT', 'email': 'mdalagoz@gmail.com', 'phone': '+903125677232'}], 'overallOfficials': [{'name': 'Musa Zengin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Atatürk Chest Diseases and Chest Surgery Training and Research Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Atatürk Chest Diseases and Chest Surgery Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal İnvestigator', 'investigatorFullName': 'Musa Zengin', 'investigatorAffiliation': 'Atatürk Chest Diseases and Chest Surgery Training and Research Hospital'}}}}