Ignite Creation Date:
2025-12-24 @ 1:33 PM
Ignite Modification Date:
2026-02-20 @ 1:44 PM
Study NCT ID:
NCT00639795
Status:
TERMINATED
Last Update Posted:
2013-07-03
First Post:
2008-03-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of the Effect of Regional Nerve Blocks on Pain and Inflammation After Video Assisted Thorascopic Lung Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'whyStopped': 'inadequate sample population', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'completionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-07-02', 'studyFirstSubmitDate': '2008-03-14', 'studyFirstSubmitQcDate': '2008-03-19', 'lastUpdatePostDateStruct': {'date': '2013-07-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-03-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparing the degree of systemic post-operative inflammation with the degree of post-operative pain', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'To compare the degree of pain and nausea', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Thoracic paravertebral block', 'Cytokines', 'Video assisted thorascopic surgery', 'Pain'], 'conditions': ['Pain']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare:\n\n1. The degree of systemic postoperative inflammation (cytokine measurement) with the degree of post-operative pain\n2. The degree of pain and nausea and\n3. The pre and post operative pulmonary functions\n\nfollowing Video Assisted Thorascopic Surgery (VATS) performed under general anesthesia with the addition of intra-operative single-injection paravertebral blockade vs general anesthesia with a sham intra-operative paravertebral nerve blockade', 'detailedDescription': '* Enrolled subjects scheduled to undergo video-assisted thorascopic surgery (VATS) will be randomized to receive either paravertebral block or placebo(adhesive bandage applied at the site).\n* All patients will undergo a standardized general anesthetic regimen.\n* Human biological specimens will be collected preoperatively, postoperatively (in the PACU) at the first morning blood draw of POD 1, POD 2, POD 3, and POD 10-14 (follow-up visit at surgeons office)and analyzed for CRP, Cortisol \\& inflammatory markers (IL-1beta,IL-2,IL-4,IL-5,IL-6, IL-8, IL-10,INF-gamma, TNF-alpha)\n* Pulmonary functions (FEV1/FEV6) will be performed in the pre-op holding area prior to sedation and post-operatively on the morning of post-op day 1.\n* Pain levels will be assessed with the Wong-Baker Faces and Visual Analog Scale pre-operatively in the PACU and hourly for a total of 6 hours and then every 8 hrs.and with patient self-report in diary after discharge.\n* Pain levels will be assessed with the McGill-Melzack Pain Questionnaire pre-operatively, the evening of POD1-POD3 and by patient self-report in diary after discharge.\n* Nausea assessments will occur at arrival on floor and every 8 hours thereafter until discharge.\n* Narcotic requirements will be collected daily in the hospital and by patient self report in diary thereafter.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age greater than 18\n* Planned thoracoscopy with low probability(by surgeon estimate) of conversion to open procedure\n\nExclusion Criteria:\n\n* Age less than 18\n* Clinical or laboratory evidence of systemic infection\n* Current pregnancy as assessed by preoperative urine HCG test\n* Serious, uncontrolled, non-malignant illness\n* Malignant illness requiring systemic chemotherapy in the last 6 months\n* Documented allergy to oxycodone, morphine sulfate or acetaminophen\n* Contraindication to peripheral nerve blockade or general anesthesia including:\n\n 1. patient refusal\n 2. active infection at site of planned block\n 3. documented allergy to any local or general anesthetic medications\n 4. significant coagulopathy( prothrombin time \\>15 seconds, INR\\>1.5\n 5. pre-existing neuropathy and medical conditions or deformities which would compromise block or anesthetic safety\n* Planned pleurodesis\n* Current use of high dose inhaled or systemic steroids\n* Current use of Amiodarone (Cordarone)\n* Morbid obesity (BMI=40kg/m2)\n* Patients with clinically significant mental health issues such as psychosis requiring treatment with antipsychotic medications.\n* Patients unable to consent\n* Patients with active infections requiring antibiotics within one month of registration\n* Participation in other clinical trials that may interfere with this study'}, 'identificationModule': {'nctId': 'NCT00639795', 'acronym': 'VATS_IM', 'briefTitle': 'Study of the Effect of Regional Nerve Blocks on Pain and Inflammation After Video Assisted Thorascopic Lung Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Memorial Medical Center'}, 'officialTitle': 'Prospective Randomized Trial Evaluating the Effects of Paravertebral Nerve Blocks on Postoperative Pain and the Perioperative Inflammatory Response Following Video Assisted Thorascopic Surgery', 'orgStudyIdInfo': {'id': 'A-13101.2 MMC 06-28'}, 'secondaryIdInfos': [{'id': 'Proposal Log Number 04070001'}, {'id': 'Award Number W81XWH-05-1-0047'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'A', 'description': 'Patients randomized to receive thoracic paravertebral nerve blockade in addition to general endotracheal anesthesia during video assisted thoracoscopy procedure', 'interventionNames': ['Procedure: Thoracic Paravertebral Nerve Block']}, {'type': 'SHAM_COMPARATOR', 'label': 'B', 'description': 'Patients randomized to receive sham single-injection thoracic peripheral nerve blockade (no injection) in addition to general endotracheal anesthesia', 'interventionNames': ['Procedure: Thoracic Paravertebral Nerve Block']}], 'interventions': [{'name': 'Thoracic Paravertebral Nerve Block', 'type': 'PROCEDURE', 'otherNames': ['VATS IM', 'Thoracic Peripheral Nerve Blockade'], 'description': 'One Single-injection, thoracic peripheral nerve blockade performed intraoperatively following patient induction with general endotracheal anesthesia', 'armGroupLabels': ['A']}, {'name': 'Thoracic Paravertebral Nerve Block', 'type': 'PROCEDURE', 'description': 'Sham single-injection thoracic peripheral nerve blockade following patient induction with general endotracheal anesthesia', 'armGroupLabels': ['B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15905', 'city': 'Johnstown', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Memorial Medical Center', 'geoPoint': {'lat': 40.32674, 'lon': -78.92197}}], 'overallOfficials': [{'name': 'William T Fritz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Memorial Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Memorial Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Henry M. Jackson Foundation for the Advancement of Military Medicine', 'class': 'OTHER'}, {'name': 'U.S. Army Medical Research and Development Command', 'class': 'FED'}], 'responsibleParty': {'oldNameTitle': 'William T Fritz, M.D.', 'oldOrganization': 'Laurel Anesthesia Group, Memorial Medical Center'}}}}