Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2026-02-06 @ 12:26 AM
Study NCT ID:
NCT02592460
Status:
COMPLETED
Last Update Posted:
2019-02-15
First Post:
2015-10-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Postoperative Pain and Polyamines-poor Diet (DOLAMINE)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 542}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-14', 'studyFirstSubmitDate': '2015-10-29', 'studyFirstSubmitQcDate': '2015-10-29', 'lastUpdatePostDateStruct': {'date': '2019-02-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-10-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of patients whose worst pain, as measured on an visual analogic scale ranging from 0 mm to 100 mm, was at least once rated as 30 mm or more.', 'timeFrame': 'Eight days after surgery', 'description': 'The worst pain will be assessed retrospectively the eighth day after surgery'}], 'secondaryOutcomes': [{'measure': 'Percentage of patients with a need for grade II analgesics', 'timeFrame': 'Eighth day after surgery'}, {'measure': 'Overall tramadol consumption , expressed in mg.', 'timeFrame': 'Eight days after surgery'}, {'measure': 'Worst pain, expressed in mm, measured on an visual analogic scale ranging from 0 mm to 100 mm', 'timeFrame': 'Eight days after surgery', 'description': 'The worst pain will be assessed retrospectively the eighth day after surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Postoperative Pain']}, 'descriptionModule': {'briefSummary': "Animal studies have shown that the level of pain sensitivity is highly dependent on the amount of polyamines in food. This fundamental observation of a nutritional approach to pain led the authors to develop diets completely depleted in polyamines whose anti-nociceptive properties have been confirmed in animals.\n\nPostoperative pain after foot surgery are currently fairly well controlled but at the cost of a high consumption of grade II analgesics which is associated with a high rate of side effects (nausea, vomiting ...). The investigators' hypothesis is that a diet low in polyamines may have an additive effect on pain control and reduce the consumption of level 2 analgesics.\n\nThe objective of this study is to show the efficacy of a polyamines-poor diet on postoperative pain in ambulatory surgery of the foot."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* foot ambulatory orthopedic surgery\n* surgery scheduled at least 10 days after the inclusion consultation\n\nExclusion Criteria:\n\n* other diet susceptible to interfere with the poor or high-polyamines diets (e.g. diabetic patients)\n* contraindication to tramadol or to NSAIDs\n* pregnant or breastfeeding woman\n* patient under legal protection\n* patient's opposition to participate in the study\n* poor understanding of French\n* absence of affiliation to social security\n* participation to another study"}, 'identificationModule': {'nctId': 'NCT02592460', 'acronym': 'DOLAMINE', 'briefTitle': 'Postoperative Pain and Polyamines-poor Diet (DOLAMINE)', 'organization': {'class': 'OTHER', 'fullName': 'Groupe Hospitalier Diaconesses Croix Saint-Simon'}, 'officialTitle': 'Impact on Pain of a Preoperative Polyamines-poor Diet After Orthopedic Surgery of the Foot', 'orgStudyIdInfo': {'id': 'WGF_2014-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'poor-polyamines diet', 'interventionNames': ['Other: poor-polyamines diet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'high-polyamines diet', 'interventionNames': ['Other: high polyamines diet']}], 'interventions': [{'name': 'poor-polyamines diet', 'type': 'OTHER', 'description': 'Patients in this will receive a poor-polyamines diet during a week before and a week after foot surgery', 'armGroupLabels': ['poor-polyamines diet']}, {'name': 'high polyamines diet', 'type': 'OTHER', 'description': 'Patients in this will receive a high-polyamines diet during a week before and a week after foot surgery', 'armGroupLabels': ['high-polyamines diet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75020', 'city': 'Paris', 'state': 'Île-de-France Region', 'country': 'France', 'facility': 'Groupe hospitalier Diaconesses Croix Saint Simon', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Groupe Hospitalier Diaconesses Croix Saint-Simon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}