Ignite Creation Date:
2025-12-24 @ 6:44 PM
Ignite Modification Date:
2025-12-27 @ 3:49 AM
Study NCT ID:
NCT07110857
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-08
First Post:
2025-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Superficial Cervical Plexus Block in Oncological Throat and Neck Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D066008', 'term': 'Cervical Plexus Block'}, {'id': 'D000077212', 'term': 'Ropivacaine'}], 'ancestors': [{'id': 'D009407', 'term': 'Nerve Block'}, {'id': 'D000765', 'term': 'Anesthesia, Conduction'}, {'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}, {'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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 346}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2027-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-01', 'studyFirstSubmitDate': '2025-07-25', 'studyFirstSubmitQcDate': '2025-08-01', 'lastUpdatePostDateStruct': {'date': '2025-08-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Amount of morphine', 'timeFrame': 'The first 24 hours postoperatively', 'description': 'The analysis metric is the cumulative amount of IV morphine (amount of morphine titrated in SSPI + administered by PCA in mg and mg/kg/day) during the first 24 hours postoperatively.'}], 'secondaryOutcomes': [{'measure': 'Remifentanil consumption', 'timeFrame': 'Intraoperative', 'description': 'Change in remifentanil consumption during surgery per unit time (in µg/kg/min). The analysis metric is the cumulative sum of intraoperative remifentanil during surgery.'}, {'measure': 'Consumption of morphine', 'timeFrame': 'In the first 72 hours postoperatively', 'description': 'Change in consumption of morphine equivalent intravenous or oral in the first 72 hours postoperatively (mg and mg/kg). The analysis metric is the cumulative amount of morphine administered during the first 72 hours postoperatively.'}, {'measure': 'Evaluation in cervical VAS and flap site VAS score', 'timeFrame': 'On arrival, 1 hour later, 2 hours later, 4 hours later', 'description': "Change in cervical VAS (Visual Analog Scale) and flap site VAS score in PACU (post anesthesia care units). The VAS measures pain intensity on a scale from 0 to 10, with two end points representing 0 'no pain' and 10 'pain as bad as it could possibly be'. The analysis metric is the change from baseline."}, {'measure': 'Evaluation in cervical VAS in dynamic conditions and flap site VAS score', 'timeFrame': 'Day 1, day 15 (or hospital discharge), 1 month and 3 months', 'description': "Change in cervical VAS (Visual Analog Scale) in dynamic conditions and flap site VAS score. The VAS measures pain intensity on a scale from 0 to 10, with two end points representing 0 'no pain' and 10 'pain as bad as it could possibly be'. The analysis metric is the change from baseline."}, {'measure': 'DN4 score assessment', 'timeFrame': 'Day 1, Day 15 (or hospital discharge), 1 month and 3 month', 'description': "DN4 (Douleur Neuropathique 4) score change. When the practitioner suspects neuropathic pain, the DN4 questionnaire is a useful diagnostic tool. If the patient's score is equal to or greater than 4/10, the test is positive indicating the presence of neuropathic pain. The analysis metric is the final value."}, {'measure': 'Evaluation of adverse effects attributable to morphine consumption', 'timeFrame': 'Day 1, Day 15 (or hospital discharge)', 'description': 'Report / Change of adverse effects attributable to morphine consumption (desaturation, nausea-vomiting, etc.). The analysis metric is the difference between the post-processing value and the initial value.'}, {'measure': 'Evaluation of the rate of patients with early rehabilitation', 'timeFrame': 'Initiated on Day 1', 'description': 'Change in the rate of patients with early rehabilitation: standing, wheelchair, physiotherapy'}, {'measure': 'The length of time spent in hospital', 'timeFrame': 'Duration of hospital stay assessed up to 15 days or hospital discharge', 'description': 'Reduction in the length of hospitalization between the control arm and the experimental arm. The analysis metric is the final value.'}, {'measure': 'Evaluation of the E Satis MSO FNAH score', 'timeFrame': 'Day 15 (or hospital discharge)', 'description': 'Improvement of the E-Satis MSO (medical-surgery-obstetrics) FNAH (French National Authority for Health) score. E-Satis is expressed out of 100. Score close to 100: positive experience'}, {'measure': 'Evaluation of the Mc Gill Pain score (SF-MPQ-2)', 'timeFrame': 'Day 1, day 15 (or hospital discharge), 1 month and 3 months', 'description': 'Improvement in Mc Gill Pain score (SF-MPQ-2). The McGill Pain Index is a self-assessment scale that describes the quality and intensity of pain from 0 to 50. A score close to 50 indicates extremely severe pain.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['the superficial cervical plexus block', 'surgery', 'locoregional anesthesia', 'locoregional analgesia', 'ENT surgery'], 'conditions': ['ENT Cancers']}, 'descriptionModule': {'briefSummary': 'This national, prospective, multicenter, randomized study aims to reduce the amount of intravenous morphine (titration + PCA morphine) during the first 24 postoperative hours via a locoregional anesthesia technique in patients undergoing throat and neck cancer surgery.', 'detailedDescription': 'The incidence of throat and neck (ENT) cancers is 15000 new cases/year in France. Nowadays, there are no studies with a sufficient level of evidence to establish formal recommendations on analgesic treatments to be applied in the context of ENT cancer surgery.\n\nAs cancer surgery causes severe acute postoperative pain and chronic pain, loco-regional anesthesia (LRA) plays an increasingly role in the prevention of this type of pain.\n\nHowever, nowadays there is no data in the literature highlighting the interest of LRA in the context of ENT cancer surgery, despite a significant theoretical benefit.\n\nThe superficial cervical block, already used in carotid or thyroid surgery, has already shown its value. It seems logical to propose this block in throat and neck cancer surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patient undergoing ENT cancer surgery with cervicotomy\n* Adult patient having received oral information from a doctor and signed written consent\n* Affiliation to a social security scheme, Universal Medical Coverage (CMU)\n\nExclusion Criteria:\n\n* Patient refusal\n* Altered mental faculties or patient unable to give consent\n* Allergy to local anesthetics\n* Severe respiratory pathology (altered respiratory function tests with 50% \\< FEV1 \\< 80%, FEV1/FVC \\< 70%, COPD stage 2 or more)\n* Preoperative SpO2 less than 92% in ambient air\n* Left heart failure NYHA 3 or more, impaired LVEF \\< 30% or less\n* Lower respiratory infection in the month preceding surgery\n* History of ENT cancer surgery with cervical lymph node dissection\n* Pregnant or breastfeeding woman\n* Patient under AME\n* Patient under guardianship or reinforced curatorship\n* Participation in other interventional research'}, 'identificationModule': {'nctId': 'NCT07110857', 'acronym': 'BCS-ORL', 'briefTitle': 'Evaluation of the Superficial Cervical Plexus Block in Oncological Throat and Neck Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Evaluation of the Superficial Cervical Plexus Block in Oncological Throat and Neck Surgery', 'orgStudyIdInfo': {'id': 'APHP230866'}, 'secondaryIdInfos': [{'id': 'PHRCI-2022-38', 'type': 'OTHER_GRANT', 'domain': 'Ministry of health, France'}, {'id': '2024-510942-15-00', 'type': 'CTIS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Naropeine Arm', 'description': 'Superficial cervical plexus block with 0.2 % ropivacaine (Naropeine)', 'interventionNames': ['Procedure: Cervical plexus block with 0.2 % Naropeine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Arm', 'description': 'Superficial cervical plexus block with 0.9 % saline placebo', 'interventionNames': ['Procedure: Cervical plexus block with saline placebo']}], 'interventions': [{'name': 'Cervical plexus block with 0.2 % Naropeine', 'type': 'PROCEDURE', 'description': 'Under ultrasound guidance, a superficial cervical plexus block is performed immediately after induction and before skin incision by injecting 15-25 mL of 0.2 % ropivacaine (Naropeine) uni- or bilateral depending on the surgical incision', 'armGroupLabels': ['Naropeine Arm']}, {'name': 'Cervical plexus block with saline placebo', 'type': 'PROCEDURE', 'description': 'Under ultrasound guidance, a superficial cervical plexus block is performed immediately after induction and before skin incision by injecting 15-25 mL of 0.9 % saline uni- or bilateral depending on the surgical incision', 'armGroupLabels': ['Placebo Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '59000', 'city': 'Lille', 'country': 'France', 'contacts': [{'name': 'Elsa JOZEFOWICZ', 'role': 'CONTACT'}, {'role': 'CONTACT', 'email': 'Elsa.jozefowicz@chu-lille.fr'}], 'facility': 'CHU de Lille- Hôpital Roger Salengro', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '13005', 'city': 'Marseille', 'country': 'France', 'contacts': [{'name': 'Elsa Giuly yague, PH', 'role': 'CONTACT', 'email': 'elsagiuly@ap-hm.fr'}], 'facility': 'Assistance publique - Hôpitaux de Marseille', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '75010', 'city': 'Paris', 'country': 'France', 'contacts': [{'name': 'Sonia BOUKTHIR, Dr', 'role': 'CONTACT'}, {'role': 'CONTACT', 'email': 'sonia.boukthir@aphp.fr'}], 'facility': 'AP-HP - Hôpital Lariboisière', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75015', 'city': 'Paris', 'country': 'France', 'contacts': [{'name': 'Laetitia Desplanque', 'role': 'CONTACT', 'email': 'laetitia.desplanque@aphp.fr'}], 'facility': 'Assistance publique - Hôpitaux de Paris', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '76000', 'city': 'Rouen', 'country': 'France', 'contacts': [{'name': 'Jean SELIM', 'role': 'CONTACT'}, {'role': 'CONTACT', 'email': 'Jean.selim@chu-rouen.fr'}], 'facility': 'CHU Charles Nicolle', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'zip': '92150', 'city': 'Suresnes', 'country': 'France', 'contacts': [{'name': 'Morgan Le Guen, Pr', 'role': 'CONTACT'}, {'role': 'CONTACT', 'email': 'm.leguen@hopital-foch.com'}], 'facility': 'hôpital Foch', 'geoPoint': {'lat': 48.87143, 'lon': 2.22929}}, {'zip': '94805', 'city': 'Villejuif', 'country': 'France', 'contacts': [{'name': 'Deborah TEMPESTA, Dr', 'role': 'CONTACT'}, {'role': 'CONTACT', 'email': 'Deborah.TEMPESTA@gustaveroussy.fr'}], 'facility': 'Institut Gustave Roussy', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}], 'centralContacts': [{'name': 'Alexia EP', 'role': 'CONTACT', 'email': 'alexia.ep@aphp.fr', 'phone': '01 40 27 18 63'}, {'name': 'Liliane HAMMANI-BERKANI', 'role': 'CONTACT', 'email': 'liliane.berkani@aphp.fr', 'phone': '01 56 09 37 62'}], 'overallOfficials': [{'name': 'Laetitia Desplanque', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'timeFrame': 'Two years after the last publication', 'ipdSharing': 'YES', 'description': 'Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared', 'accessCriteria': 'Data sharing must be accepted by the sponsor and the PI based on a scientific project and scientific involvement of the PI team. Collaboration will be fostered. The founder could be involved in the decision. Teams wishing obtain IPD must meet the sponsor and IP team to present scientific (and commercial) purpose, IPD needed, format of data transmission, and timeframe. Technical feasibility and financial support will be discussed before mandatory contractualization. Processing of shared data must comply with European General Data Protection Regulation (GDPR).'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of Health, France', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}