Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2025-12-31 @ 4:33 AM
Study NCT ID:
NCT01825993
Status:
UNKNOWN
Last Update Posted:
2013-04-08
First Post:
2013-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
RANDOMISED STUDY OF EPIDURAL VS MPCA MORPHINE VS TAPP IN LAPAROSCOPIC SIGMOIDECTOMY
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077554', 'term': 'Levobupivacaine'}, {'id': 'D009020', 'term': 'Morphine'}], 'ancestors': [{'id': 'D002045', 'term': 'Bupivacaine'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009022', 'term': 'Morphine Derivatives'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 225}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2015-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-04-05', 'studyFirstSubmitDate': '2013-03-29', 'studyFirstSubmitQcDate': '2013-04-05', 'lastUpdatePostDateStruct': {'date': '2013-04-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-04-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'EVA (POSTOPERATIVE PAIN)', 'timeFrame': '72 H POSTOPERATIVE', 'description': 'The investigators asked the patient the postoperative pain during teh first 72 hours by EVA scale.'}], 'secondaryOutcomes': [{'measure': 'ADVERSE EFFECTS', 'timeFrame': 'five days', 'description': 'the investigators look for adverse effects'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Peridural catheter', 'Morphine PCA', 'Transabdominal Block', 'laparoscopic sigmoidectomy'], 'conditions': ['Sigmoidal Tumour']}, 'descriptionModule': {'briefSummary': 'The investigators would study the control of postoperative pain with peridural catheter, morphine PCA ev or Transabdominal block.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age more than 18\n* Laparoscopic sigmoidectomy\n* Informed consent firmed\n\nExclusion Criteria:\n\n* ASA IV\n* Urgent surgery\n* Sigmoid tumour stage IV\n* Cronic pain treatment\n* No informed consent firmed\n* Paliative surgery'}, 'identificationModule': {'nctId': 'NCT01825993', 'acronym': '2013/004', 'briefTitle': 'RANDOMISED STUDY OF EPIDURAL VS MPCA MORPHINE VS TAPP IN LAPAROSCOPIC SIGMOIDECTOMY', 'organization': {'class': 'OTHER', 'fullName': 'Corporacion Parc Tauli'}, 'officialTitle': 'RANDOMISED STUDY ABOUT POTSOTERATORY PAIN CONTROL IN LAPAROSCOPIC SIGMOIDECTOMY', 'orgStudyIdInfo': {'id': 'CIR TAP 2013'}, 'secondaryIdInfos': [{'id': '2013-000556-17', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PCA endovenous', 'description': '1mg/10 min Morphine', 'interventionNames': ['Drug: MORPHINE']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PERIDURAL CATHETER', 'description': 'Peridural L-bupivacaine 0.25%', 'interventionNames': ['Drug: L-BUPIVACAINE ; MORPHINE']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'TANSABDOMINAL BLOCK (TAP)', 'description': 'L-BUPIVACAINE im', 'interventionNames': ['Drug: L-BUPIVACAINE ; MORPHINE']}], 'interventions': [{'name': 'L-BUPIVACAINE ; MORPHINE', 'type': 'DRUG', 'otherNames': ['PERIDURAL L-BUPIVACAINE', 'PCA MORPHINE'], 'armGroupLabels': ['PERIDURAL CATHETER', 'TANSABDOMINAL BLOCK (TAP)']}, {'name': 'MORPHINE', 'type': 'DRUG', 'armGroupLabels': ['PCA endovenous']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08208', 'city': 'Sabadell', 'state': 'Sabadell-Barcelona', 'country': 'Spain', 'contacts': [{'name': 'Mora L Laura, MD', 'role': 'CONTACT', 'email': 'Lmora@tauli.cat', 'phone': '34 937231010', 'phoneExt': '24190'}], 'facility': 'Corporacion Parc Tauli', 'geoPoint': {'lat': 41.54329, 'lon': 2.10942}}, {'zip': '08208', 'city': 'Sabadell', 'state': 'Sabadell-barcelona', 'country': 'Spain', 'contacts': [{'name': 'MORA L LAURA, MD', 'role': 'CONTACT', 'email': 'Lmora@tauli.cat', 'phone': '34937231010', 'phoneExt': '21490'}, {'name': 'mora', 'role': 'CONTACT'}], 'facility': 'Corporacion Parc Tauli', 'geoPoint': {'lat': 41.54329, 'lon': 2.10942}}], 'centralContacts': [{'name': 'MORA L. LAURA, MD', 'role': 'CONTACT', 'email': 'Lmora@tauli.cat', 'phone': '34937231010', 'phoneExt': '21490'}], 'overallOfficials': [{'name': 'PUJOL GEMMA, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Corporacion Parc Tauli'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Corporacion Parc Tauli', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'General Surgeon', 'investigatorFullName': 'LAURA MORA LOPEZ', 'investigatorAffiliation': 'Corporacion Parc Tauli'}}}}