Ignite Creation Date:
2025-12-24 @ 9:48 PM
Ignite Modification Date:
2025-12-25 @ 7:27 PM
Study NCT ID:
NCT06313632
Status:
TERMINATED
Last Update Posted:
2025-05-01
First Post:
2024-03-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Erector Spinae Plane Block With Bupivacaine for Medical Thoracoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010995', 'term': 'Pleural Diseases'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'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'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002045', 'term': 'Bupivacaine'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Triple blind study'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'whyStopped': 'interim, lack of obvious benefit', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2024-03-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-03-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-28', 'studyFirstSubmitDate': '2024-03-07', 'studyFirstSubmitQcDate': '2024-03-13', 'lastUpdatePostDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analog Scale (VAS) for Pain', 'timeFrame': '2 hours after the intervention', 'description': 'Global chest pain score measured using the Visual Analog Scale (VAS) post-procedure in recovery. Participants will be asked to mark the level of their pain along a line, score ranges 0 (no-pain) to 100 (worst-imaginable pain), with higher scores indicating worse outcomes.'}], 'secondaryOutcomes': [{'measure': 'Change in the Numerical Rating Scale', 'timeFrame': 'At 2 hours post-intervention and 24 hours post-intervention', 'description': 'Change in chest pain measured on the numerical rating scale post-procedure in recovery versus 24 hours post-procedure. This will be done using a numerical scale from 1 to 10 (1 = very mild pain, and 10 = very severe pain), with higher scores indicating greater levels pain. Data will be collected at the time of discharge from the recovery unit (2 hours post-intervention) vs 24 hours after.'}, {'measure': 'Type of Analgesic use', 'timeFrame': 'within the first 24 hours after the intervention', 'description': 'Type of Analgesic use within the first 24 hours after the intervention. The patient will be asked regarding the types of analgesics used (i.e. non-steroidal anti-inflammatories, opioids, etc.).'}, {'measure': 'Number of Analgesic use', 'timeFrame': 'within the first 24 hours after the intervention', 'description': 'Number of Analgesics used within the first 24 hours after the intervention. The patient will be asked regarding number of doses.'}, {'measure': 'Dosage of Analgesic use', 'timeFrame': 'within the first 24 hours after the intervention', 'description': 'Dosage of Analgesic used within the first 24 hours after the intervention. The patient will be asked regarding dose used.'}, {'measure': 'Quality of Recovery-15 (QoR-15) Survey Score', 'timeFrame': 'within the first 24 hours after the intervention', 'description': 'Compare quality of recovery 24 hours after the intervention. This will be evaluated with the QoR-15 questionnaire, scores range Minimum: 0 to Maximum: 150, with higher scores indicating a better outcome and better quality of recovery.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Thoracoscopy', 'Pleuroscopy', 'Regional Anesthesia', 'Erector Spinae Plane Block', 'Pain Control'], 'conditions': ['Pleural Disease', 'Postoperative Pain']}, 'referencesModule': {'references': [{'pmid': '40099426', 'type': 'DERIVED', 'citation': 'Luebbert E, Salguero BD, Joy G, Salman S, Lo Cascio CM, Echevarria G, Chaddha U, Pai B H P. Benefits of Using Peripheral Nerve Blocks for Medical Thoracoscopy: A Retrospective Analysis. J Bronchology Interv Pulmonol. 2025 Mar 18;32(2):e1006. doi: 10.1097/LBR.0000000000001006. eCollection 2025 Apr 1.'}]}, 'descriptionModule': {'briefSummary': 'PlAcebo versus erector spINae pLane block for mEdical ThoracoScopy Study (PAINLESS). This is a prospective triple-blind, randomized controlled trial that evaluates the efficacy of erector spinae plane block (ESPB) with Bupivacaine in reducing pain after medical thoracoscopy (MT) in addition to monitored anesthesia care vs monitored anesthesia care alone.', 'detailedDescription': 'This is a single-site prospect triple-blind, randomized controlled trial, that evaluates the efficacy of erector spinae plane (ESP) block with Bupivacaine in reducing pain after medical thoracoscopy (MT). The study aims to compare the effectiveness of ESP block with monitored anesthesia care (MAC) vs MAC alone for patients undergoing MT. Patient will be evaluated post operatively in the post anesthesia care unit and 24 hours after the procedure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Referral for medical thoracoscopy\n* Age ≥ 18\n\nExclusion criteria:\n\n* Inability to provide informed consent.\n* Study subject has any disease or condition that interferes with safe completion of the study including:\n\n * Allergic reaction to Bupivacaine.\n * Need for pleurodesis.\n * Allergies to lidocaine or other local anesthetics.\n * Pregnancy.\n * Advanced liver disease where the clinician deems the procedure unsafe.'}, 'identificationModule': {'nctId': 'NCT06313632', 'briefTitle': 'Erector Spinae Plane Block With Bupivacaine for Medical Thoracoscopy', 'organization': {'class': 'OTHER', 'fullName': 'Icahn School of Medicine at Mount Sinai'}, 'officialTitle': 'A Triple-Blind Randomized Controlled Trial of Erector Spinae Plane Block With Bupivacaine Versus Placebo in Patients Undergoing Medical Thoracoscopy', 'orgStudyIdInfo': {'id': 'STUDY-23-01105'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ESP with Bupivacaine Group', 'description': 'Erector spinae plane block with bupivacaine.', 'interventionNames': ['Drug: Bupivacaine injection', 'Other: Monitored Anesthesia Care']}, {'type': 'SHAM_COMPARATOR', 'label': 'ESP with Placebo', 'description': 'Erector spinae plane injection with a placebo (normal saline).', 'interventionNames': ['Drug: Placebo', 'Other: Monitored Anesthesia Care']}], 'interventions': [{'name': 'Bupivacaine injection', 'type': 'DRUG', 'description': 'Erector spinae plane block with bupivacaine (0.5%) 30 mL once', 'armGroupLabels': ['ESP with Bupivacaine Group']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'ESP with matching saline placebo', 'armGroupLabels': ['ESP with Placebo']}, {'name': 'Monitored Anesthesia Care', 'type': 'OTHER', 'description': 'Standard monitored anesthesia care', 'armGroupLabels': ['ESP with Bupivacaine Group', 'ESP with Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10019', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Mount Sinai West Hospital', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Udit Chaddha, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Principal Investigator'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data will only be processed by the research team. There is no plan to share IPD and only de-identified data will be collected.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Icahn School of Medicine at Mount Sinai', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Udit Chaddha', 'investigatorAffiliation': 'Icahn School of Medicine at Mount Sinai'}}}}