Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2025-12-26 @ 2:58 AM
Study NCT ID:
NCT04737902
Status:
COMPLETED
Last Update Posted:
2021-02-04
First Post:
2021-01-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
ESP Block, CNP and QoL After VATS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D009437', 'term': 'Neuralgia'}], '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'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2020-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-30', 'studyFirstSubmitDate': '2021-01-30', 'studyFirstSubmitQcDate': '2021-01-30', 'lastUpdatePostDateStruct': {'date': '2021-02-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of chronic neurophatic pain', 'timeFrame': '3 month', 'description': 'incidence of CNP three months postoperatively (POP) in patients undergoing VATS surgery with ESPB as the regional anaesthesia technique'}], 'secondaryOutcomes': [{'measure': 'Postoperative pain', 'timeFrame': '24 hours', 'description': 'pain control at PACU, 12 and 24 hours POP'}, {'measure': 'Quality of Life POP', 'timeFrame': '3 months POP', 'description': 'Quality of Life by EQ-5D'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['regional anesthesia', 'postoperative pain', 'video-assisted thoracoscopic surgery', 'erector spinae plane block', 'Neuropathic Pain', 'Quality of Life'], 'conditions': ['Postoperative Pain', 'Video-assisted Thoracoscopic Surgery']}, 'referencesModule': {'references': [{'pmid': '28248713', 'type': 'BACKGROUND', 'citation': 'Bayman EO, Parekh KR, Keech J, Selte A, Brennan TJ. A Prospective Study of Chronic Pain after Thoracic Surgery. Anesthesiology. 2017 May;126(5):938-951. doi: 10.1097/ALN.0000000000001576.'}, {'pmid': '27501016', 'type': 'BACKGROUND', 'citation': 'Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.'}]}, 'descriptionModule': {'briefSummary': 'The Erector Spinae Plane Block (ESPB) is an adequate alternative for pain management after video-assisted thoracoscopy surgery (VATS). The incidence of postoperative chronic neuropathic pain (CNP) and the quality of life (QoL) in patients with ESPB after VATS remain unknown. We hypothesised that patients with ESPB would have a low incidence of acute and CNP and would report a good QoL up to three months after VATS.', 'detailedDescription': 'We, therefore, performed this prospective observational study. The a priori primary outcome was incidence of CNP three months postoperatively (POP) in patients undergoing VATS surgery with ESPB as the regional anaesthesia technique. The secondary outcome was to describe pain control at PACU, 12 and 24 hours POP and QoL reported up to three months after surgery. We hypothesised that patients with ESPB would have a low incidence of acute and CNP and report a good QoL.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Primary care clinic', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients who underwent VATS and required at least one day of hospital stay after surgery\n\nExclusion Criteria:\n\n* patients with mental or physical limitation to answer the questionnaires.\n* patients who required mechanical ventilation.\n* patients who required surgery conversion to thoracotomy.\n* patients who declined consent.'}, 'identificationModule': {'nctId': 'NCT04737902', 'briefTitle': 'ESP Block, CNP and QoL After VATS', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Universitario San Ignacio'}, 'officialTitle': 'Erector Spinae Plane (ESP) Block, Incidence of Chronic Neuropathic Pain (CNP) and Quality of Life (QoL) After VATS. An Observational Study.', 'orgStudyIdInfo': {'id': 'FMCIE-0043-19'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'VATS with ESPB', 'description': 'Study subjects underwent anaesthesia and VATS without a change in their routine care. At the end of the surgery, an erector spinae plane block was performed for acute pain control following our institutional protocol for perioperative care.', 'interventionNames': ['Procedure: Erector spinae plane block']}], 'interventions': [{'name': 'Erector spinae plane block', 'type': 'PROCEDURE', 'description': 'Unilateral ESP block was performed between T3 and T7 levels depending on the thoracic surgical incision. The patient is placed in lateral decubitus position, under sterile conditions, a high frequency (6-15 MHz) linear-array transducer (Sonosite® Edge II, Bothell, USA) was placed in a longitudinal parasagittal orientation 2 cm from the posterior midline to visualise the tips of the transverse processes deep to the erector spinae muscle (ESM). A 21 G, 50 mm or 100 mm needle (Pajunk UniPlex NanoLine; Germany) was advanced in-plane with the ultrasound beam. The needle tip was directed to the plane between the transverse process and the posterior fascia of the ESM. Correct needle tip location was confirmed by ultrasound visualisation of linear fluid spread in the fascial plane. The injection of 0.5 to 1 ml of bupivacaine was 0.5% with epinephrine 5 µg/ml; then, a total of 20-30 ml of the same local anaesthetic was administered.', 'armGroupLabels': ['VATS with ESPB']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11001000', 'city': 'Bogota', 'state': 'Cundinamarca', 'country': 'Colombia', 'facility': 'Hospital Universitario'}], 'overallOfficials': [{'name': 'Lorena Díaz-Bohada, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitario San Ignacio'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Universitario San Ignacio', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}