Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2025-12-29 @ 9:44 PM
Study NCT ID:
NCT05700357
Status:
RECRUITING
Last Update Posted:
2024-02-28
First Post:
2023-01-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Different Local Anesthetic Volumes for TPVB in Post-thoracotomy Analgesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059787', 'term': 'Acute Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 75}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-12-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-12-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-26', 'studyFirstSubmitDate': '2023-01-07', 'studyFirstSubmitQcDate': '2023-01-17', 'lastUpdatePostDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Scores', 'timeFrame': '1st hour after surgery', 'description': 'Pain will be assessed at the first-hour rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain).'}, {'measure': 'Pain Scores', 'timeFrame': '2nd-hour after surgery', 'description': 'Pain will be assessed at the 2nd-hour rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain).'}, {'measure': 'Pain Scores', 'timeFrame': '4th-hour after surgery', 'description': 'Pain will be assessed at the 4th-hour rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain).'}, {'measure': 'Pain Scores', 'timeFrame': '12th-hour after surgery.', 'description': 'Pain will be assessed at the 12th-hour rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain).'}, {'measure': 'Pain Scores', 'timeFrame': '24th-hour after surgery.', 'description': 'Pain will be assessed at the 24th-hour rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain).'}, {'measure': 'Pain Scores', 'timeFrame': '48th-hour after surgery.', 'description': 'Pain will be assessed at the 48th-hour rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain).'}], 'secondaryOutcomes': [{'measure': 'Morphine Consumption', 'timeFrame': '24 hours after surgery', 'description': 'Morphine consumption for 24 hours will be recorded'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Thoracic Paravertebral Block', 'Thoracotomy', 'Postoperative Analgesia', 'Acute Pain', 'Local Anesthetic']}, 'descriptionModule': {'briefSummary': 'Thoracotomy is one of the most painful operations known. Therefore, it causes severe acute pain. If pain is not controlled, it increases the frequency of postoperative pulmonary complications and postoperative morbidity. It can even cause chronic pain in the future. Thoracic epidural analgesia (TEA) is the gold standard method in the treatment of pain after thoracotomy. Thoracic paravertebral block (TPVB) is known as the most effective method after TEA. The fact that TPVB has fewer side effects than TEA increases the use of TPVB. There is no consensus on the dose of analgesia in studies. In the literature, volumes between 20 ml and 30 ml are frequently used for TPVB in recent years. This study, it was aimed to compare the efficacy of 20 ml, 25 ml, and 30 ml volumes of TPVB with local anesthetic at the same concentration (0.25% bupivacaine) on postoperative analgesia in patients undergoing thoracotomy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 to 80 years old\n* American Society of Anesthesiologists (ASA) physical status I-II-III\n* BMI 18 to 40 kg/m2\n* Elective thoracotomy surgery\n\nExclusion Criteria:\n\n* Patient refusing the procedure\n* Emergency surgery\n* History of chronic opioid or analgesic used'}, 'identificationModule': {'nctId': 'NCT05700357', 'briefTitle': 'Different Local Anesthetic Volumes for TPVB in Post-thoracotomy Analgesia', 'organization': {'class': 'OTHER', 'fullName': 'Ankara City Hospital Bilkent'}, 'officialTitle': 'Comparison of Different Local Anesthetic Volumes of Thoracic Paravertebral Block Application in Post-thoracotomy Analgesia', 'orgStudyIdInfo': {'id': 'E.Kurul-E1-22-3143'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Thoracic Paravertebral Block 20 ml', 'description': 'In patients who are planned to have a thoracic paravertebral block, the needle will be advanced to the paravertebral area with ultrasound-guided in-plane technique. 20 ml of 0.25% bupivacaine will be injected into this area.', 'interventionNames': ['Procedure: TPVB with 20 ml']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Thoracic Paravertebral Block 25 ml', 'description': 'In patients who are planned to have a thoracic paravertebral block, the needle will be advanced to the paravertebral area with ultrasound-guided in-plane technique. 25 ml of 0.25% bupivacaine will be injected into this area.', 'interventionNames': ['Procedure: TPVB with 25 ml']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Thoracic Paravertebral Block 30 ml', 'description': 'In patients who are planned to have a thoracic paravertebral block, the needle will be advanced to the paravertebral area with ultrasound-guided in-plane technique. 30 ml of 0.25% bupivacaine will be injected into this area.', 'interventionNames': ['Procedure: TPVB with 30 ml']}], 'interventions': [{'name': 'TPVB with 20 ml', 'type': 'PROCEDURE', 'description': 'The thoracic paravertebral block will be applied to the patients with 20 ml of 0.25% bupivacaine under real-time ultrasound guidance.', 'armGroupLabels': ['Thoracic Paravertebral Block 20 ml']}, {'name': 'TPVB with 25 ml', 'type': 'PROCEDURE', 'description': 'The thoracic paravertebral block will be applied to the patients with 25 ml of 0.25% bupivacaine under real-time ultrasound guidance.', 'armGroupLabels': ['Thoracic Paravertebral Block 25 ml']}, {'name': 'TPVB with 30 ml', 'type': 'PROCEDURE', 'description': 'The thoracic paravertebral block will be applied to the patients with 30 ml of 0.25% bupivacaine under real-time ultrasound guidance.', 'armGroupLabels': ['Thoracic Paravertebral Block 30 ml']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06290', 'city': 'Çankaya', 'state': 'Ankara', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Emine N Zengin, MD', 'role': 'CONTACT', 'email': 'nilbavullu@gmail.com', 'phone': '+905063370548'}], 'facility': 'Ankara City Hospital', 'geoPoint': {'lat': 39.9179, 'lon': 32.86268}}], 'centralContacts': [{'name': 'Emine N ZENGİN', 'role': 'CONTACT', 'email': 'nilbavullu@yahoo.com', 'phone': '+905063370548'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara City Hospital Bilkent', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal İnvestigator', 'investigatorFullName': 'Nilgün Zengin', 'investigatorAffiliation': 'Ankara City Hospital Bilkent'}}}}