Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2026-01-02 @ 3:59 AM
Study NCT ID:
NCT07021651
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-15
First Post:
2025-06-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
COMPARISON OF ERECTOR SPINA PLAN BLOCK AND THORACIC PARAVERTEBRAL BLOCK FOR PERIOPERATIVE ANALGESIA
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D010268', 'term': 'Parapsychology'}], 'ancestors': [{'id': 'D001525', 'term': 'Behavioral Sciences'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-07-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-13', 'studyFirstSubmitDate': '2025-06-04', 'studyFirstSubmitQcDate': '2025-06-13', 'lastUpdatePostDateStruct': {'date': '2025-06-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Numeric Rating Scale', 'timeFrame': 'Post-operative 30 minutes, 2 hours, 6 hours, 12 hours, 24 hours', 'description': 'They will be numbered from 1 to 10. If reporting a score on a scale, please include the unabbreviated scale title, the minimum and maximum values, and whether higher scores mean a better or worse outcome.'}], 'secondaryOutcomes': [{'measure': 'Riker Agitation and Sedation Scale', 'timeFrame': 'Immediately after extubation', 'description': '7 Dangerous Agitation ... If reporting a score on a scale, please include the unabbreviated scale title, the minimum and maximum values, and whether higher scores mean a better or worse outcome.'}, {'measure': 'Patient satisfaction score:', 'timeFrame': 'Post-operative 30 minutes', 'description': "Patients' satisfaction with the quality of pain management will be assessed on the second postoperative day using the following scale: 1 = very dissatisfied; 2 = quite dissatisfied; 3 = moderate; 4 = quite satisfactory; 5 = very satisfactory.)"}, {'measure': '24-hour Tramadol usage:', 'timeFrame': 'posoperative 24 hours', 'description': 'Amount of Tramadol used per 24 hours'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Paravertebral Block']}, 'descriptionModule': {'briefSummary': 'The primary aim of this study was to compare the postoperative analgesic efficacy of thoracic paravertebral block with erector spinae plane block, which we use in thoracotomy surgeries. Secondary aims were to compare these groups in terms of Riker Agitation-Sedation Scale (RASS) scores, postoperative complications, postoperative opioid consumption, and patient satisfaction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who will undergo thoracotomy and are between the ages of 18-65\n* have American Society of Anesthesiologists (ASA) risk classification I-II will be included in the study.\n\nExclusion Criteria:\n\n* Patients who did not agree to participate in the study,\n* had an infection in the application area,\n* had coagulopathy,\n* were morbidly obese (Body mass index (BMI)\\>35),\n* had drug allergy,\n* had chronic pain, long-term opioid use, psychiatric illness history, and required emergency surgery were excluded from the study.'}, 'identificationModule': {'nctId': 'NCT07021651', 'acronym': 'A Two-Center', 'briefTitle': 'COMPARISON OF ERECTOR SPINA PLAN BLOCK AND THORACIC PARAVERTEBRAL BLOCK FOR PERIOPERATIVE ANALGESIA', 'organization': {'class': 'OTHER', 'fullName': 'Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital'}, 'officialTitle': 'A Two-Center Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'CEM'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Erektor spina plan block', 'description': 'The local anesthetic is injected into the fascial plane between the erector spinae muscle and the transverse processes of the vertebrae. This allows the anesthetic to spread cranially and caudally, affecting multiple spinal nerves', 'interventionNames': ['Procedure: Erector Spinae Plane (ESP) block admistring']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Toracik paravertebral block', 'description': 'The local anesthetic is injected into the paravertebral space, which is bordered by the vertebral bodies, intervertebral discs, parietal pleura, and superior costotransverse ligament. This space contains the spinal nerves, sympathetic chain, and intercostal vessels', 'interventionNames': ['Procedure: Thoracic Paravertebral Block administring']}], 'interventions': [{'name': 'Erector Spinae Plane (ESP) block admistring', 'type': 'PROCEDURE', 'description': 'In the ESPB group, the probe was placed longitudinally at the level of the T5 transverse process, 2-3 cm lateral from the midline. The muscles were visualized superior to the transverse process ; then, the needle was inserted in the craniocaudal direction using the in-plane technique. A dose of 2 mL normal saline were injected into the two layers of the interfacial area under the erector spinae muscle, and the proper injection site was confirmed. After visualizing the linear spread of saline in the fascial plane, 20 mL of 0.25% bupivacaine was injected there for the block.', 'armGroupLabels': ['Erektor spina plan block']}, {'name': 'Thoracic Paravertebral Block administring', 'type': 'PROCEDURE', 'description': 'In the TPVB group, the probe was placed 2-3 cm laterally and vertically of the T5 spinous process. Once the transverse process, corresponding paravertebral space, internal intercostal membrane, and pleura was identified , the needle was inserted in the lateromedial direction using the in-plane technique. After confirmation of pleural displacement with 2 mL saline, 20 mL of 0.25% bupivacaine was administered for the block.', 'armGroupLabels': ['Toracik paravertebral block']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kayapınar', 'state': 'Di̇yarbakir', 'country': 'Turkey (Türkiye)', 'contacts': [{'role': 'CONTACT', 'email': 'hulyatosunsoner@hotmail.com'}], 'facility': 'Health Sciences University Gazi Yaşargil Training and Research Hospital', 'geoPoint': {'lat': 37.55762, 'lon': 41.16231}}], 'centralContacts': [{'name': 'Hülya Tosun Söner, doktor', 'role': 'CONTACT', 'email': 'hulyatosunsoner@hotmail.com', 'phone': '+905352792102'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Anesthesiology and Reanimation Spesialist', 'investigatorFullName': 'Hülya Tosun Söner', 'investigatorAffiliation': 'Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital'}}}}