Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2026-02-08 @ 3:24 PM
Study NCT ID:
NCT02821169
Status:
COMPLETED
Last Update Posted:
2025-12-22
First Post:
2016-06-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Infiltration in the Region of the Palatine Ganglion Spheno by Ropivacaine on Postoperative Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077212', 'term': 'Ropivacaine'}, {'id': 'D000077330', 'term': 'Saline Solution'}, {'id': 'D007267', 'term': 'Injections'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 184}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2019-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-15', 'studyFirstSubmitDate': '2016-06-29', 'studyFirstSubmitQcDate': '2016-06-29', 'lastUpdatePostDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-07-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual analog scale', 'timeFrame': 'at the 2 postoperative hours', 'description': 'Measure the intensity pain, in the group treated with Ropivacaine.'}], 'secondaryOutcomes': [{'measure': 'Analgesics consumption orally', 'timeFrame': 'during the 7 days post-surgery', 'description': 'patient-controlled administration'}, {'measure': 'Administration of analgesics by parenteral route', 'timeFrame': 'at the 2 postoperative hours', 'description': 'patient-controlled administration'}, {'measure': 'Visual analog scale for the intensity postoperative pain', 'timeFrame': 'at the 4 and at the 6 postoperative hours', 'description': 'patient-controlled administration'}, {'measure': 'Visual analog scale for the during postoperative pain', 'timeFrame': 'At Morning and evening between the 1 and 7 days post surgery', 'description': 'self-assessment by the patient at home on the information collection book'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['sinus surgery', 'sphenopalatin ganglion', 'ropivacaine', 'local anesthesia'], 'conditions': ['Pain']}, 'referencesModule': {'references': [{'pmid': '34013619', 'type': 'RESULT', 'citation': 'Morisse M, Rysman B, Szymanski C, Fackeure R, Mouawad F, Mortuaire G. A randomized placebo-controlled trial assessing sphenopalatine ganglion block in endoscopic sinus surgery. Int Forum Allergy Rhinol. 2021 Sep;11(9):1384-1386. doi: 10.1002/alr.22804. Epub 2021 May 19. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'Endoscopic sinus surgery (ESS) is a prevalent surgical procedure. It is required in many chronic rhinosinusitis for whom the medical treatment failed. In order to improve the postoperative management of patients treated with ESS, we aim to assess the analgesic action of local injection of ropivacaine in the nasal fossa.', 'detailedDescription': 'A prospective randomized double blind placebo controlled study was designed. Local injection of ropivacaine or placebo was conducted at the end of the surgical procedure in both nasal fossa through endoscopic view in the sphenopalatine region.\n\nPain was measured in the postoperative course with visual analogic scale in the recovery room and the rhinologic department.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients requiring endoscopic sinus surgery\n* ASA score 1 or 2\n* patients with health care insurance\n* approved consent\n\nExclusion Criteria:\n\n* any sinonasal malignant tumor\n* renal failure, hepatic disorder, respiratory deficiency, cardiovascular diseases\n* neurologic disorders\n* alcohol or drugs addiction\n* preoperative facial pain from an extranasal origin\n* coagulation disorders\n* antidepressive treatment'}, 'identificationModule': {'nctId': 'NCT02821169', 'acronym': 'ROPI_POSTOP', 'briefTitle': 'Infiltration in the Region of the Palatine Ganglion Spheno by Ropivacaine on Postoperative Pain', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Lille'}, 'officialTitle': 'Impact of Infiltration in the Region of the Palatine Ganglion Spheno by Ropivacaine on Postoperative Pain in the Setting of Endoscopic Sinonasal Surgery.', 'orgStudyIdInfo': {'id': '2013_07'}, 'secondaryIdInfos': [{'id': '2013-004410-17', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'saline solution 0.9%', 'description': 'injection of saline solution in the sphenopalatine area in both nasal fossa', 'interventionNames': ['Drug: saline solution 0.9%']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ropivacaine (2mg/ml)', 'description': 'injection of ropivacaine in the sphenopalatine area in both nasal fossa', 'interventionNames': ['Drug: ropivacaine']}], 'interventions': [{'name': 'ropivacaine', 'type': 'DRUG', 'otherNames': ['NAROPEINE'], 'description': 'injection of 4mL of ropivacaine in the sphenopalatine area through an endoscopic approach', 'armGroupLabels': ['ropivacaine (2mg/ml)']}, {'name': 'saline solution 0.9%', 'type': 'DRUG', 'otherNames': ['NaCL 0.9% injectable'], 'description': 'injection of 4 mL of saline solution in the sphenopalatine area through an endoscopic approach', 'armGroupLabels': ['saline solution 0.9%']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lille', 'country': 'France', 'facility': 'CHRU, Hôpital Claude Huriez', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}], 'overallOfficials': [{'name': 'Goeffrey Mortuaire, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Lille'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Lille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}