Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2026-01-29 @ 1:18 PM
Study NCT ID:
NCT04403360
Status:
UNKNOWN
Last Update Posted:
2020-05-27
First Post:
2020-05-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Erector Spinae Plane Block After Lumbar Spinal Stenosis Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013130', 'term': 'Spinal Stenosis'}], 'ancestors': [{'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2021-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-05-21', 'studyFirstSubmitDate': '2020-05-21', 'studyFirstSubmitQcDate': '2020-05-21', 'lastUpdatePostDateStruct': {'date': '2020-05-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total 24 h Piritramide consumption', 'timeFrame': '24 hours', 'description': 'Total consumption of Piritramide consumption after surgery'}], 'secondaryOutcomes': [{'measure': 'Quebec back pain disability scale (QBPDS)', 'timeFrame': 'At 2 months]', 'description': 'A questionnaire developed to measure the level of functional disability for patients with low back pain'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lumbar Spinal Stenosis', 'Erector Spinae Plane Block']}, 'referencesModule': {'references': [{'pmid': '27501016', 'type': 'RESULT', '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': 'Lumbar spinae stenosis surgery is a frequent intervention resulting in important postoperative pain. Management of this postoperative pain is thus important. Different pain management therapies exist. The erector spinae plane (ESP) block was described in 2016. It involves the injection of local anesthetics into the interfascial plane, deep to erector spinae muscle, allowing the blockade of the dorsal and ventral rami of the thoracic spinal nerves. It was initially proposed for analgesia of costal fractures, pulmonary lobectomy and thoracic vertebrae. The ESP block (ESPB) could probably be extended to a large number of surgical procedures. ESPB has so far not been investigated in lumbar spinae stenosis surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Any lumbar spinae surgery on 2 or more lumbar levels\n\nExclusion Criteria:\n\n* Contraindication to NSAID\n* Allergy to any local anesthetics'}, 'identificationModule': {'nctId': 'NCT04403360', 'briefTitle': 'Erector Spinae Plane Block After Lumbar Spinal Stenosis Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Clinique Saint Pierre Ottignies'}, 'officialTitle': 'Impact of the Erector Spinae Plane Block on the Postoperative Pain After Lumbar Spinal Stenosis Surgery: Single Blind Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'B707201837276'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Erector Spinae plane Block (ESPB) group', 'description': 'The ultrasound-guided ESPB was realized at T12 level (levo bupivacaine 0.25% + epinephrine 1:200.000 4mg.kg-1 body weight)after the induction of anesthesia but before the start of the surgery.', 'interventionNames': ['Procedure: ESPB']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Local anesthesia infiltration by the surgeon', 'description': 'The surgeon infiltrates the surgical site after skin incision with local anesthetics (Levo Bupivacaïne 0.25% + epinephrine 1:200.000 4mg.kg-1 body weight)', 'interventionNames': ['Procedure: Local infiltration by the surgeon']}], 'interventions': [{'name': 'ESPB', 'type': 'PROCEDURE', 'description': 'Ultrasound guided performance of ESPB at T12 level after the induction of anesthesia but before the start of the surgery', 'armGroupLabels': ['Erector Spinae plane Block (ESPB) group']}, {'name': 'Local infiltration by the surgeon', 'type': 'PROCEDURE', 'description': 'Local infiltration of anesthetics at surgical site after skin incision', 'armGroupLabels': ['Local anesthesia infiltration by the surgeon']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1340', 'city': 'Ottignies', 'state': 'Brabant Wallon', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Georges SAMOURI, MD', 'role': 'CONTACT', 'email': 'georges.samouri@cspo.be', 'phone': '003210437260'}, {'name': 'Nicolas PARISI, MD', 'role': 'CONTACT', 'email': 'nicolas.parisi@cspo.be', 'phone': '003210437608'}], 'facility': 'Clinique Saint Pierre', 'geoPoint': {'lat': 50.66535, 'lon': 4.56679}}], 'centralContacts': [{'name': 'Georges SAMOURI, MD', 'role': 'CONTACT', 'email': 'georges.samouri@cspo.be', 'phone': '003210437260'}, {'name': 'Nicolas PARISI, MD', 'role': 'CONTACT', 'email': 'nicolas.parisi@cspo.be', 'phone': '003210437608'}], 'overallOfficials': [{'name': 'Georges SAMOURI, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinique Saint Pierre Ottignies'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'All data will be presented in future manuscripts.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Clinique Saint Pierre Ottignies', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Georges Samouri M.D.', 'investigatorFullName': 'Georges Samouri', 'investigatorAffiliation': 'Clinique Saint Pierre Ottignies'}}}}