Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-30 @ 3:23 AM
Study NCT ID:
NCT07441161
Status:
COMPLETED
Last Update Posted:
2026-02-27
First Post:
2026-02-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Erector Spinae Plane Block in Major Video-assisted Thoracic Surgery Compared to Intrathecal Morphine and Intercostal Nerve Block.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 113}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-01-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-02-23', 'studyFirstSubmitDate': '2026-02-16', 'studyFirstSubmitQcDate': '2026-02-23', 'lastUpdatePostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative pain and dose of intravenous rescue morphine', 'timeFrame': '0,6,12,24, 48 hours', 'description': 'Postoperatively, we assessed the Numeric rating scale (NRS, values between 0 (less pain) and 10 (worst pain) score on arrival at the Postoperative care unit (PACU) (0 hours) and at 6, 12, 24, and 48 hours after arrival, and the dose of intravenous rescue morphine used.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Video Assisted Thoracic Surgery (VATS)', 'Erector Spinae Plane Block', 'Regional Anaesthesia', 'ERAS Programmes']}, 'descriptionModule': {'briefSummary': 'An ambispective observational study based on two groups (ITM and ICNB) from an earlier clinical trial conducted by our team(15) and a third group (ESPB) that received the new type of block, as we sought to assess the efficacy of this procedure and compare results with the other groups.', 'detailedDescription': 'Introduction Thoracic surgery remains associated with a high incidence of moderate-to-severe acute postoperative pain despite minimally invasive approaches. However, a regional analgesic technique of choice for video-assisted thoracoscopic surgery (VATS) has not yet been established.\n\nThe literature describes several regional techniques. The objective of this study was to assess the efficacy and safety of ESPB compared to ITM and ICNB up to 48 hours after surgery.\n\nMaterials and methods An ambispective observational study of patients undergoing major VATS was carried out based on two groups (ITM, n=9; ICNB, n=90) from an earlier clinical trial conducted by our team, and a third group (ESPB, n=113) recruited prospectively at a later stage.\n\nPain was assessed at rest and on coughing on arrival at the post-anaesthesia care unit (PACU) and at 6, 12, 24, and 48 hours after surgery. Further, doses of rescue intravenous morphine, and adverse effects were recorded.\n\nStatistical analysis For pain both at rest and on coughing, a two-way repeated measures analysis of variance was used to compare the mean differences between groups (treatment type) and assess interactions between group and time (pain at five time points). The Bonferroni correction was applied for post-hoc comparisons.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '18 years of age, were undergoing major lung resection by VATS', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age, were undergoing major lung resection by VATS, and received ESPB at Donostia University Hospital between January 2023 and February 2024.\n\nExclusion Criteria:\n\n* A lack of written informed consent, a history of drug abuse, long-term treatment with opioids, and contraindications to the block, as well as unexpected conversion to open surgery (thoracotomy) or minor surgery (wedge resection'}, 'identificationModule': {'nctId': 'NCT07441161', 'acronym': 'AESPVIMVIB', 'briefTitle': 'Efficacy of Erector Spinae Plane Block in Major Video-assisted Thoracic Surgery Compared to Intrathecal Morphine and Intercostal Nerve Block.', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Donostia'}, 'officialTitle': 'Efficacy of Erector Spinae Plane Block in Major Video-assisted Thoracic Surgery Compared to Intrathecal Morphine and Intercostal Nerve Block: An Ambispective Observational Study', 'orgStudyIdInfo': {'id': 'GON-ESB-2022-01'}, 'secondaryIdInfos': [{'id': '2023-GON-ESB-01', 'type': 'OTHER', 'domain': 'HDonostia'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'ESPB group', 'description': 'patients undergoing major VATS with ESPB', 'interventionNames': ['Other: regional block']}, {'label': 'ITM group', 'description': 'patients undergoing major VATS with ITM', 'interventionNames': ['Other: Spinal analgesia']}, {'label': 'ICNB group', 'description': 'patients undergoing major VATS with ICNB', 'interventionNames': ['Other: regional block']}], 'interventions': [{'name': 'Spinal analgesia', 'type': 'OTHER', 'description': 'Intrathecal morphine', 'armGroupLabels': ['ITM group']}, {'name': 'regional block', 'type': 'OTHER', 'description': 'erector spinae plane block', 'armGroupLabels': ['ESPB group']}, {'name': 'regional block', 'type': 'OTHER', 'description': 'intercostal block with levobupivacaine', 'armGroupLabels': ['ICNB group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20008', 'city': 'Donostia / San Sebastian', 'state': 'Gipuzkoa', 'country': 'Spain', 'facility': 'Serrano Anguita 1, 7º', 'geoPoint': {'lat': 43.31283, 'lon': -1.97499}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Donostia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Phd, Head of the Anesthesiology and Critical Care Section', 'investigatorFullName': 'Silvia González Santos', 'investigatorAffiliation': 'Hospital Donostia'}}}}