Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2026-03-06 @ 7:40 PM
Study NCT ID:
NCT02630160
Status:
COMPLETED
Last Update Posted:
2016-10-12
First Post:
2015-11-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Influence of Local Infiltration Analgesia by Catheter in Postoperative Control Pain After Total Hip Replacement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059352', 'term': 'Musculoskeletal Pain'}, {'id': 'D025981', 'term': 'Hip Injuries'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002045', 'term': 'Bupivacaine'}, {'id': 'D004837', 'term': 'Epinephrine'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D015306', 'term': 'Biogenic Monoamines'}, {'id': 'D001679', 'term': 'Biogenic Amines'}, {'id': 'D002395', 'term': 'Catecholamines'}, {'id': 'D002396', 'term': 'Catechols'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-10', 'studyFirstSubmitDate': '2015-11-30', 'studyFirstSubmitQcDate': '2015-12-10', 'lastUpdatePostDateStruct': {'date': '2016-10-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-12-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in pain measured with a visual analog scale', 'timeFrame': '36 hours', 'description': 'Visual analog pain scale score every eight hours for 36 hours postoperatively'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Musculoskeletal Pain', 'Hip Injuries']}, 'descriptionModule': {'briefSummary': 'A randomized double-blind clinical trial was performed. There were 4 groups according to catheter placement and infusion constituents: 1) Intraarticular catheter + anesthetics; 2) Intraarticular catheter +placebo; 3) Subfascial catheter + anesthetics; 4) Subfascial catheter + placebo. The anesthetics infusion contained bupivacaine (bolus + continuous perfusion up to 36 hours). The placebo solution consisted in physiological serum (bolus + continuous perfusion up to 36 hours). Randomization was performed in the hospital pharmacy and the surgeon kept out the surgical field when the resident placed the catheter. The same conventional analgesic schedule was prescribed to all patients: PCA (patient controlled analgesia) + paracetamol 1g/6h + dexketoprofen 50mg/12h. The pain was evaluated by means of PCA (patient controlled analgesia) shots and the VAS (visual analog scale). Side effects, time to start rehabilitation and time to discharge were also analyzed. A statistical analysis was performed to compare all this variables between the 4 groups (SPSS 18.0).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primary total Hip Replacement\n\nExclusion Criteria:\n\n* Allergic to Bupivacaine'}, 'identificationModule': {'nctId': 'NCT02630160', 'acronym': 'ILIACPCPTHR', 'briefTitle': 'The Influence of Local Infiltration Analgesia by Catheter in Postoperative Control Pain After Total Hip Replacement', 'organization': {'class': 'OTHER', 'fullName': 'Parc de Salut Mar'}, 'officialTitle': 'The Influence of Local Infiltration Analgesia by Catheter in Postoperative Control Pain After Total Hip Replacement', 'orgStudyIdInfo': {'id': '2013/5138/I'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Intraarticular Catheter with anesthesic', 'description': 'Intraarticular infusion with Bupivacaine Hydrochloride', 'interventionNames': ['Drug: Bupivacaine hydrochloride']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Intraarticular Physiological Saline', 'description': 'Infusion of Physiological Saline \\[Flebobag Salina Fisiologica Grifols 0.9%\\] Sterile Solution by intraarticular catheter', 'interventionNames': ['Other: Physiological Saline']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Perifascial Catheter with anesthesic', 'description': 'Perifascial infusion with Bupivacaine Hydrochloride', 'interventionNames': ['Drug: Bupivacaine hydrochloride']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Perifascial Physiological Saline', 'description': 'Infusion of Physiological Saline \\[Flebobag Salina Fisiologica Grifols 0.9%\\] Sterile Solution by Perifascial catheter', 'interventionNames': ['Other: Physiological Saline']}], 'interventions': [{'name': 'Bupivacaine hydrochloride', 'type': 'DRUG', 'otherNames': ['Bupivacaine / epinephrine, Vivacaine'], 'description': 'Intraarticular infusion with bupivacaine', 'armGroupLabels': ['Intraarticular Catheter with anesthesic', 'Perifascial Catheter with anesthesic']}, {'name': 'Physiological Saline', 'type': 'OTHER', 'otherNames': ['Flebobag Salina Fisiologica Grifols 0.9%'], 'description': 'Intraarticular infusion physiological serum', 'armGroupLabels': ['Intraarticular Physiological Saline', 'Perifascial Physiological Saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08003', 'city': 'Barcelona', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital del Mar', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'overallOfficials': [{'name': 'Daniel Pérez Prieto', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital del Mar'}, {'name': 'Marta Cuenca Llavall', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospital del Mar'}, {'name': 'Fernando Marques Lopez', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hospital del Mar'}, {'name': 'Alfonso Leon Garcia', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospital del Mar'}, {'name': 'Francisco Javier Santiveri Papiol', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospital del Mar'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Parc de Salut Mar', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Daniel Pérez Prieto', 'investigatorAffiliation': 'Parc de Salut Mar'}}}}