Ignite Creation Date:
2025-12-24 @ 2:31 PM
Ignite Modification Date:
2025-12-26 @ 7:08 AM
Study NCT ID:
NCT05762159
Status:
COMPLETED
Last Update Posted:
2024-05-21
First Post:
2023-02-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Analgesic Territory Assessment of the Spinal Erector Block Using Pupillometry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000085143', 'term': 'Routinely Collected Health Data'}], 'ancestors': [{'id': 'D019538', 'term': 'Health Care Surveys'}, {'id': 'D006302', 'term': 'Health Services Research'}, {'id': 'D006285', 'term': 'Health Planning'}, {'id': 'D004472', 'term': 'Health Care Economics and Organizations'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-05-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-20', 'studyFirstSubmitDate': '2023-02-28', 'studyFirstSubmitQcDate': '2023-02-28', 'lastUpdatePostDateStruct': {'date': '2024-05-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'variation of the pupil size (in percentage)', 'timeFrame': 'During the surgery', 'description': 'Evaluation the territory covered by the spinal erector block by variation of the pupil size (in percentage).\n\nVariation of the pupil size on stimulation will allow to deduce if the dermatome is covered by the spinal erector block analgesia.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['spinal erector block', 'pupillometry', 'loco-regional anesthesia', 'osteosynthesis'], 'conditions': ['Anesthesia, Local']}, 'descriptionModule': {'briefSummary': 'Few works have studied the area of analgesia covered by the spinal erector block in an objective manner, especially on the cephalo-caudal spread. The available data are dissection works or subjective data such as thermoalgesic or epicritic sensitivity.\n\nThis information would however be relevant in order to propose a better analgesia. Indeed, it could explain certain failures by insufficient diffusion of the block. The use of a multistage block could be relevant, especially in the case of osteosynthesis on several vertebral levels.', 'detailedDescription': 'Pupillometry makes possible to monitor analgesia based on the pupillary dilation reflex to pain. The goal is to establish an objective mapping of these type of analgesia from these data.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients receiving erector spinae block for pain management of spinal osteosynthesis will be included.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients receiving erector spinae block for pain management of spinal osteosynthesis\n\nExclusion Criteria:\n\n* Patient refusal\n* Known allergy to local anesthetics\n* Contraindication to locoregional anesthesia (haemostasis disorder, infection, peripheral neuropathy)\n* Technical impossibility to perform a spinal erector block\n* Pathology with dysautonomia altering the pupillary reflex: diabetes mellitus with diabetic retinopathy, multiple sclerosis, systemic amyloidosis, uncontrolled hypertension, glaucoma\n* Current treatment likely to alter pupillary dilation reflex to pain : antiemetic (droperidol, metoclopramide), alpha-2 agonist (clonidine)\n* Serious psychiatric history\n* Drug abuse\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT05762159', 'acronym': 'TEASER', 'briefTitle': 'Analgesic Territory Assessment of the Spinal Erector Block Using Pupillometry', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Saint Etienne'}, 'officialTitle': 'Analgesic Territory Assessment of the Spinal Erector Block Using Pupillometry', 'orgStudyIdInfo': {'id': 'IRBN1272022/CHUSTE'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'erector spinae block', 'description': 'Patients receiving erector spinae block for pain management of spinal osteosynthesis. Pupillometer will be realized during analgesia (usual practice).', 'interventionNames': ['Other: data collected']}], 'interventions': [{'name': 'data collected', 'type': 'OTHER', 'description': 'data collected:\n\n* Morphological data of the patients\n* Data of the erector block realization\n* Pupillometric data :the variation of the pupil size on stimulation (in percentage of the base diameter)', 'armGroupLabels': ['erector spinae block']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Saint-Etienne', 'country': 'France', 'facility': 'CHU Saint-Etienne', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}], 'overallOfficials': [{'name': 'Maxime Wodey, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU SAINT-ETIENNE'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Saint Etienne', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}