Ignite Creation Date:
2025-12-25 @ 3:18 AM
Ignite Modification Date:
2026-03-09 @ 4:02 PM
Study NCT ID:
NCT04250805
Status:
TERMINATED
Last Update Posted:
2024-01-31
First Post:
2020-01-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trial Evaluating the Efficacy of the Combination of ROpivacaine With Reference XYlocaine in the Evaluation of Pain During the Installation of Percutaneous Radiological GASTrostomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001068', 'term': 'Feeding and Eating Disorders'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008012', 'term': 'Lidocaine'}, {'id': 'D000077212', 'term': 'Ropivacaine'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'whyStopped': 'Difficulties in recruiting patients', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-10-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2024-01-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-30', 'studyFirstSubmitDate': '2020-01-30', 'studyFirstSubmitQcDate': '2020-01-30', 'lastUpdatePostDateStruct': {'date': '2024-01-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Level of Pain', 'timeFrame': '24 hours', 'description': 'Two points diminution for maximal pain felt during a twenty four hours after percutaneous gastrostomy under radiological guidance. It will be measured with a visual analogue scale starting at zero for no pain and ending at ten for maximal pain felt.'}], 'secondaryOutcomes': [{'measure': 'Level of Anxiety and Depression', 'timeFrame': '10 days', 'description': 'Hospital Anxiety and Depression scores will be reported and analysed for each patient. This scale is an instrument for detecting anxiety and depressive disorders. It has 14 listed items from 0 to 3. Seven questions relate to anxiety (total A) and seven others relate to the depressive dimension (total D), allowing thus obtaining two scores (maximum score of each score = 21). To detect anxious and depressive symptoms, the following interpretation can be offered for each of the scores (A and D):\n\n* 7 or less: absence of symptoms;\n* 8 to 10: doubtful symptomatology;\n* 11 and more: certain symptomatology.'}, {'measure': 'Level of quality of life', 'timeFrame': '10 days', 'description': "Brief Pain Inventory scores will be reported to evaluate the level of the patients' quality of life. For each question, score is comprised between 0 and 10, with 0 meaning no pain or no resounding on life activity, and 10 meaning the worst pain ever, and the worst resounding on life activity."}, {'measure': 'Level of satisfaction', 'timeFrame': '10 days', 'description': "Patients' satisfaction about their analgesic care will be reported with a visual analogue scale starting at zero meaning no satisfaction, and ending at ten meaning the highest satisfaction possible."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cancer', 'Gastrostomy', 'Percutaneous technique', 'Radiological guidance', 'Lidocaine', 'Ropivacaine', 'Pain'], 'conditions': ['Cancer', 'Feeding Disorders']}, 'descriptionModule': {'briefSummary': 'Gastrostomy is an intra-gastric nutritional enteral device that could be put in place by percutaneous technique under radiological guidance: allowing local anesthesia. However, there is no clear recommendation about local analgesia during this exam. Operator can chose Lidocaine with a short period of action, or Ropivacaine with a longer period of action. The association of these two drugs could enhance the analgesia post procedure. The main objective of this study is to decrease maximal pain felt during a twenty four hour stay, after a gastrostomy under percutaneous technique with radiological guidance.', 'detailedDescription': 'Gastrostomy is an intra-gastric nutritional enteral device, allowing the nutritional support for patients presenting oral feeding disorders. Gastrostomy could be put in place by different manners:\n\n* Chirurgical technique or endoscopy: with general anesthesia;\n* Percutaneous technique under radiological guidance: allowing local anesthesia. This last one is better tolerated by weak patients, and involves less complication.\n\nHowever, there is no clear recommendation about local analgesia during this exam. Operator can chose Lidocaine with a short period of action, or Ropivacaine with a longer period of action.\n\nThe association of these two drugs could enhance the analgesia post procedure. Indeed, pain felt during the twenty four hours post procedure seems to be the most frequent adverse effect reported by patients.\n\nPain could decrease significantly when Ropivacaine is added to the reference Xylocaine. Ropivacaine had already proved its efficacy in association with other antalgics.\n\nThe main objective of this study is to decrease maximal pain felt during a twenty four hour stay, after a gastrostomy under percutaneous technique with radiological guidance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria :\n\n* Major patient;\n* Having an indication for placement of PRG (percutaneous radiological gastrostomy);\n* Patient hospitalized for a minimum of 24 hours post gastrostomy;\n\nNon-inclusion criteria :\n\n* Pregnant or lactating woman;\n* Legal incapacity or limited legal capacity. Medical or psychological conditions which do not allow the subject to understand the study and sign the consent (art. L.1121-6, L.1121-7, L.1211-8, L.1211-9);\n* Not knowing how to read and / or write French;\n* Allergy and / or known hypersensitivity to lidocaine and / or ropivacaine or to other local anesthetics with amide bond or to one of the excipients;\n* Recurrent porphyrias (genetic, hereditary diseases affecting the production of hemoglobin);\n* Patient on beta blockers during the installation of PRG (Percutaneous Radiological Gastrostomy);\n* Indication of gastrostomy button placement.'}, 'identificationModule': {'nctId': 'NCT04250805', 'acronym': 'GASTROXY', 'briefTitle': 'Trial Evaluating the Efficacy of the Combination of ROpivacaine With Reference XYlocaine in the Evaluation of Pain During the Installation of Percutaneous Radiological GASTrostomy', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Saint Etienne'}, 'officialTitle': 'Trial Evaluating the Efficacy of the Combination of ROpivacaine With Reference XYlocaine in the Evaluation of Pain During the Installation of Percutaneous Radiological GASTrostomy', 'orgStudyIdInfo': {'id': '2019-1201'}, 'secondaryIdInfos': [{'id': '2019-004835-22', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Lidocaine', 'description': 'Patients will receive Lidocaine alone during percutaneous gastrostomy under radiological guidance', 'interventionNames': ['Drug: Lidocaine']}, {'type': 'EXPERIMENTAL', 'label': 'Lidocaine and Ropivacaine', 'description': 'Patients will receive Lidocaine and Ropivacaine during percutaneous gastrostomy under radiological guidance', 'interventionNames': ['Drug: Lidocaine', 'Drug: Ropivacaine']}], 'interventions': [{'name': 'Lidocaine', 'type': 'DRUG', 'description': 'Patients will receive Lidocaine during percutaneous gastrostomy under radiological guidance.', 'armGroupLabels': ['Lidocaine', 'Lidocaine and Ropivacaine']}, {'name': 'Ropivacaine', 'type': 'DRUG', 'description': 'Patients will receive Ropivacaine during percutaneous gastrostomy under radiological guidance.', 'armGroupLabels': ['Lidocaine and Ropivacaine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '42270', 'city': 'Saint-Priest-en-Jarez', 'country': 'France', 'facility': 'CHU de Saint-Etienne', 'geoPoint': {'lat': 45.4739, 'lon': 4.37678}}, {'zip': '42270', 'city': 'Saint-Priest-en-Jarez', 'country': 'France', 'facility': 'Institut de Cancérologie Lucien Neuwirth', 'geoPoint': {'lat': 45.4739, 'lon': 4.37678}}], 'overallOfficials': [{'name': 'Guillaume Etievent, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institut de Cancérologie Lucien Neuwirth'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Saint Etienne', 'class': 'OTHER'}, 'collaborators': [{'name': 'Institut de Cancérologie de la Loire', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}