Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2026-02-25 @ 4:58 PM
Study NCT ID:
NCT01726205
Status:
COMPLETED
Last Update Posted:
2012-11-14
First Post:
2012-11-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Perioperative Pregabalin and Continuous Wound Infusion for Pain Control Following Thoracotomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069583', 'term': 'Pregabalin'}], 'ancestors': [{'id': 'D005680', 'term': 'gamma-Aminobutyric Acid'}, {'id': 'D000613', 'term': 'Aminobutyrates'}, {'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'completionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-11-09', 'studyFirstSubmitDate': '2012-11-09', 'studyFirstSubmitQcDate': '2012-11-09', 'lastUpdatePostDateStruct': {'date': '2012-11-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-11-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'side effects, pain at 1 and 3 months, incidence of neuropathic pain', 'timeFrame': '3 months'}], 'primaryOutcomes': [{'measure': 'Pain control', 'timeFrame': '5 days postoperatively'}], 'secondaryOutcomes': [{'measure': 'morphine consumption', 'timeFrame': '3 days postoperatively'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Post-thoracotomy Pain']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the efficacy of pregabalin or pregabalin and continuous wound infusion versus placebo for analgesia following thoracotomy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients scheduled for a thoracotomy,\n\nExclusion Criteria:\n\n* age \\>70 years\n* BMI \\> 30\n* preoperative Hb \\< 10 mg/dL\n* preexistent chronic pain\n* neurologic disease\n* chronic assumption of alcohol\n* treatment with analgesics, anxiolytics, sedatives, antidepressants, or calcium channel inhibitors'}, 'identificationModule': {'nctId': 'NCT01726205', 'briefTitle': 'Perioperative Pregabalin and Continuous Wound Infusion for Pain Control Following Thoracotomy', 'organization': {'class': 'OTHER', 'fullName': 'Attikon Hospital'}, 'orgStudyIdInfo': {'id': 'PRGCWI1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'pregabalin', 'description': 'perioperative pregabalin starting the evening before surgery, and for five days postoperatively', 'interventionNames': ['Drug: Pregabalin and normal saline infusion, PRG']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'pregabalin and continuous wound infusion', 'description': 'Pregabalin as previous group and continuous infusion of ropivacaine 0.2% via a wound catheter', 'interventionNames': ['Drug: Pregabalin and ropivacaine 02% infusion']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'Placebo drug and normal saline infusion', 'interventionNames': ['Drug: Placebo drug, normal saline infusion']}], 'interventions': [{'name': 'Pregabalin and normal saline infusion, PRG', 'type': 'DRUG', 'armGroupLabels': ['pregabalin']}, {'name': 'Pregabalin and ropivacaine 02% infusion', 'type': 'DRUG', 'armGroupLabels': ['pregabalin and continuous wound infusion']}, {'name': 'Placebo drug, normal saline infusion', 'type': 'DRUG', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Athens', 'country': 'Greece', 'facility': 'Attikon Hospital', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}], 'overallOfficials': [{'name': 'Tatiana Sidiropoulou', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Attikon Hospital'}, {'name': 'Eyaggelos Giavasopoulos', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Attikon Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Attikon Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer in Anesthesiology, University of Athens', 'investigatorFullName': 'Sidiropoulou Tatiana', 'investigatorAffiliation': 'Attikon Hospital'}}}}