Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2026-02-23 @ 2:19 AM
Study NCT ID:
NCT02173418
Status:
COMPLETED
Last Update Posted:
2016-08-17
First Post:
2014-06-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Phrenic Nerve Blockade on Acute and Chronic Shoulder Pain in Patients for Lobectomy and Pneumonectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D020069', 'term': 'Shoulder Pain'}], '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'}, {'id': 'D018771', 'term': 'Arthralgia'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077212', 'term': 'Ropivacaine'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 76}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-16', 'studyFirstSubmitDate': '2014-06-18', 'studyFirstSubmitQcDate': '2014-06-23', 'lastUpdatePostDateStruct': {'date': '2016-08-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-06-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Shoulder pain within 6 hours after the operation', 'timeFrame': 'Retrospective numerical rating scale, 6 hours after the operation', 'description': 'Shoulder pain 6 hours after the operations. Number of patients and numeric rating scale score (0-10)'}], 'secondaryOutcomes': [{'measure': 'Number of patients with shoulder pain during the first 3 postoperative days.', 'timeFrame': 'Postoperative days 0-3'}, {'measure': 'NRS for shoulder pain during the first 3 postoperative days.', 'timeFrame': 'Postoperative days 0-3', 'description': 'NRS=numerical rating scale score 0-10'}, {'measure': 'Opioid use during the first 3 postoperative days', 'timeFrame': 'Postoperative day 0-3', 'description': 'Morphine equivalents'}, {'measure': 'Time spent in the recovery room', 'timeFrame': 'Measured at discharge from the recovery room. Estimated to be on postoperative day 0 or 1.'}, {'measure': 'Shoulder pain 3 months postoperatively', 'timeFrame': '3 months postoperatively'}, {'measure': 'NRS for shoulder pain 3 months postoperatively', 'timeFrame': '3 months postoperatively', 'description': 'NRS=numerical rating scale 0-10'}, {'measure': 'Thoracic pain 3 months postoperatively', 'timeFrame': '3 months postoperatively'}, {'measure': 'NRS for thoracic pain 3 months postoperatively', 'timeFrame': '3 months postoperatively', 'description': 'NRS=numerical rating scale 0-10'}, {'measure': 'opioid use 3 months postoperatively', 'timeFrame': '3 months postoperatively'}, {'measure': 'Shoulder function 3 months postoperatively', 'timeFrame': '3 months postoperatively', 'description': 'Measured by DASH-score before the operation and after 3 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Postoperative pain', 'Acute postoperative pain', 'Chronic postoperative pain', 'Shoulder pain', 'Thoracotomy', 'Thoracoscopy'], 'conditions': ['Postoperative Pain']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to test whether peroperative infiltration of the phrenic nerve during lung surgery would protect patients against postoperative shoulder pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients planned for elective lobectomy or pneumonectomy\n2. 18 years or more on the day of the operation\n3. Danish skills appropriate for fulfilling preoperative questionnaires\n\nExclusion Criteria:\n\n1. Known contralateral paresis of the Phrenic nerve\n2. Allergy to Ropivacaine or Sodium Chloride\n3. Preoperative ipsilateral shoulder pain\n4. Infection or eczema on the intervention site. Clinical decision\n5. Dementia or similar cerebral condition that makes the subject unable to perform a NRS-score of pain. Determined by clinical evaluation\n6. Pregnancy\n7. Acute porphyria'}, 'identificationModule': {'nctId': 'NCT02173418', 'acronym': 'TOPBLOC', 'briefTitle': 'The Effect of Phrenic Nerve Blockade on Acute and Chronic Shoulder Pain in Patients for Lobectomy and Pneumonectomy', 'organization': {'class': 'OTHER', 'fullName': 'Odense University Hospital'}, 'officialTitle': 'The Effect of Phrenic Nerve Blockade on Acute and Chronic Shoulder Pain in Patients for Lobectomy and Pneumonectomy.', 'orgStudyIdInfo': {'id': '2012-002844-25'}, 'secondaryIdInfos': [{'id': 'S-20120129', 'type': 'OTHER', 'domain': 'Regional ethics committee'}, {'id': '2012-002844-25', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ropivacaine', 'description': 'Phrenic nerve block with Ropivacaine', 'interventionNames': ['Drug: Phrenic nerve block with Ropivacaine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Phrenic nerve block with Sodium chloride', 'interventionNames': ['Drug: Phrenic nerve block with saline']}], 'interventions': [{'name': 'Phrenic nerve block with Ropivacaine', 'type': 'DRUG', 'otherNames': ['Naropin'], 'armGroupLabels': ['Ropivacaine']}, {'name': 'Phrenic nerve block with saline', 'type': 'DRUG', 'otherNames': ['Sodium Chloride'], 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5000', 'city': 'Odense', 'state': 'Region Syddanmark', 'country': 'Denmark', 'facility': 'Departement of Anaesthesia and intensive care, Odense University Hospital', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}], 'overallOfficials': [{'name': 'Morten R Blichfeldt-Eckhardt, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Departement of anaesthesia and intensive care, Odense University Hospital, Odense, Denmark'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Odense University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Region of Southern Denmark', 'class': 'OTHER'}, {'name': 'University of Southern Denmark', 'class': 'OTHER'}, {'name': 'Læge Fritz Karners og hustrus Foundation', 'class': 'UNKNOWN'}, {'name': 'Overlæge dr. med. Edgar Schnohr og hustru Gilberte Schnohrs Foundation', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Afdelingslæge', 'investigatorFullName': 'Morten Rune Blichfeldt-Eckhardt', 'investigatorAffiliation': 'Odense University Hospital'}}}}