Ignite Creation Date:
2025-12-25 @ 3:00 AM
Ignite Modification Date:
2026-03-02 @ 4:24 PM
Study NCT ID:
NCT02969733
Status:
COMPLETED
Last Update Posted:
2017-09-12
First Post:
2016-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Interest of the Xylocaine® and Ketamine on the Management of Acute and Chronic Ain After Colectomy by Laparoscopy
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008012', 'term': 'Lidocaine'}, {'id': 'D007649', 'term': 'Ketamine'}], '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'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 135}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2017-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-11', 'studyFirstSubmitDate': '2016-11-14', 'studyFirstSubmitQcDate': '2016-11-17', 'lastUpdatePostDateStruct': {'date': '2017-09-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-11-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Morphine consumption', 'timeFrame': 'During the first 24 postoperative hours.'}], 'secondaryOutcomes': [{'measure': 'Morphine consumption', 'timeFrame': 'All 6 hours during the 48 postoperative hours.'}, {'measure': 'Numeric rating scale score', 'timeFrame': 'All 2 hours during the first 24 postoperative hours and all 6 hours during the 48 postoperative hours.'}, {'measure': 'Electric nociception threshold measured by PainMatcher', 'timeFrame': 'All 2 hours during the first 24 postoperative hours and all 6 hours during the 48 postoperative hours.'}, {'measure': 'Hyperalgesia of peri-scar (in cm²) with a von Frey filament (pressure of 10 grams', 'timeFrame': 'At 2 days after postoperative'}, {'measure': 'Questionnaire Douleur de Saint-Antoine (QDSA) ,', 'timeFrame': 'at 3 months, at 6 months', 'description': 'evaluation with validated scores for chronic and neuropathic pains'}, {'measure': "Questionnaire d'Evaluation des Douleurs Neuropathiques (QEDN),", 'timeFrame': 'at 3 months, at 6 months', 'description': 'evaluation with validated scores for chronic and neuropathic pains'}, {'measure': 'Time physiological function recovery', 'timeFrame': 'During the first 24 postoperative hours', 'description': 'Ability to drink, to eat, to urinate, to walk'}, {'measure': 'Duration of hospital stay', 'timeFrame': 'At 5 days after postoperative'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['postoperative analgesia', 'PainMatcher'], 'conditions': ['Pain, Postoperative']}, 'descriptionModule': {'briefSummary': 'Recent clinical studies in abdominal surgery have shown that the use of Xylocaine® parenterally intraoperative at plasma concentrations below the toxic threshold of 5 .mu.g / ml, had an analgesic effect and decreased postoperative morphine consumption.\n\nThis study aims to evaluate the activity of Xylocaine® and ketamine separately administered parenterally, in terms of postoperative morphine consumption and decrease incidences of postoperative chronic pain at 3 and 6 months after laparoscopic colectomy compared the placebo group.\n\nThe evaluation of the intensity of postoperative pain, hyperalgesia perished skin surface scarring) and pain perception threshold by Pain Matcher® confirm or not the predictive nature of these criteria in the occurrence of chronic pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Surgery: segmental or total colectomy performed by laparoscopy\n* Anesthesia state 1 and 3\n\nExclusion Criteria:\n\n* Patients classified Anesthesia state 4 or 5\n* Allergy or intolerance to any of the products used in the protocol\n* Creatinine clearance calculated by the Cockcroft formula below 50 ml / min\n* Hepatocellular insufficiency\n* Severe heart failure\n* Peptic ulcer\n* Chronic inflammatory bowel disease (IBD)\n* Previous history of epilepsy or seizures\n* Surgery emergency, palliative surgery, revision surgery\n* Chronic pain requiring regular intake of analgesics include opioids\n* Patients treated with lidocaine patch\n* Psychic Disorder\n* Additive Conduct vis-à-vis alcohol or mind-altering substances\n* Pregnant or breastfeeding women'}, 'identificationModule': {'nctId': 'NCT02969733', 'acronym': 'KETALIDO', 'briefTitle': 'The Interest of the Xylocaine® and Ketamine on the Management of Acute and Chronic Ain After Colectomy by Laparoscopy', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Lille'}, 'officialTitle': 'The Interest of the Xylocaine® and Ketamine on the Per and Postoperative Management of Acute and Chronic Postoperative Pain After Colectomy by Laparoscopy', 'orgStudyIdInfo': {'id': '2009_05/0943'}, 'secondaryIdInfos': [{'id': '2009-017682-33', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Xylocaine', 'description': 'intravenous administration', 'interventionNames': ['Drug: Xylocaine']}, {'type': 'EXPERIMENTAL', 'label': 'Ketamine', 'description': 'intravenous administration', 'interventionNames': ['Drug: Ketamine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'isotonic saline serum', 'description': 'isotonic saline serum intravenous administration', 'interventionNames': ['Drug: isotonic saline serum intravenous administration']}], 'interventions': [{'name': 'Xylocaine', 'type': 'DRUG', 'description': 'Xylocaine is administered at a dose of 1.5 mg / kg for induction and then relay by syringe pump at a dose of 1.33 mg / kg / hour will be administered throughout the duration of the intervention and for 24 hours after the end of thereof, to obtain deemed effective plasma concentrations of the order of 0.5 to 5 mcg / mL.', 'armGroupLabels': ['Xylocaine']}, {'name': 'Ketamine', 'type': 'DRUG', 'description': 'Ketamine will be administered at a dose of 0.5 mg / kg and then relay by syringe pump at a dose of 0.05 mg / kg / hour for the duration of surgery and 24 hours after the end thereof.', 'armGroupLabels': ['Ketamine']}, {'name': 'isotonic saline serum intravenous administration', 'type': 'DRUG', 'armGroupLabels': ['isotonic saline serum']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lille', 'country': 'France', 'facility': 'CHRU, Hôpital Claude Huriez', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}], 'overallOfficials': [{'name': 'Gilles Lebuffe, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Lille'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Lille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}