Ignite Creation Date:
2025-12-24 @ 3:00 PM
Ignite Modification Date:
2025-12-27 @ 5:03 AM
Study NCT ID:
NCT01110759
Status:
COMPLETED
Last Update Posted:
2013-11-01
First Post:
2010-04-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Medical Review: Hand Surgery After Local Block Versus Non-block
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002349', 'term': 'Carpal Tunnel Syndrome'}, {'id': 'D000377', 'term': 'Agnosia'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D020423', 'term': 'Median Neuropathy'}, {'id': 'D020422', 'term': 'Mononeuropathies'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009408', 'term': 'Nerve Compression Syndromes'}, {'id': 'D012090', 'term': 'Cumulative Trauma Disorders'}, {'id': 'D013180', 'term': 'Sprains and Strains'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D010146', 'term': 'Pain'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-10-30', 'studyFirstSubmitDate': '2010-04-23', 'studyFirstSubmitQcDate': '2010-04-26', 'lastUpdatePostDateStruct': {'date': '2013-11-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-04-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Outcomes', 'timeFrame': 'days to weeks', 'description': '* Presence of any other problems: (e.g., headaches, dizziness, drowsiness, fatigue, constipation, difficulty voiding.)\n* Time taken to return to normal activities after surgery\n* Satisfaction with the pain management after surgery'}], 'primaryOutcomes': [{'measure': 'postoperative pain', 'timeFrame': 'hours to months', 'description': '1. Severity of the pain experienced before patient left the surgery center and after patient arrived at home\n2. Pain medication (amounts of opioids and non opioids pills) required\n\nd)Time to suffer pain at the surgical site (hand) (days, weeks, or months)'}], 'secondaryOutcomes': [{'measure': 'Nausea', 'timeFrame': 'days to weeks', 'description': '1. Severity of the nausea experienced by the patient.\n2. Medication required.\n3. Time to suffer nausea.'}, {'measure': 'Vomiting', 'timeFrame': 'dias to weeks', 'description': '1. Severity\n2. Medication required\n3. Time to suffer vomiting'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['pain management', 'ambulatory surgery', 'opioid', 'local anesthesia', 'hand surgery', 'postoperative pain'], 'conditions': ['Carpal Tunnel Syndrome']}, 'descriptionModule': {'briefSummary': 'In this study, the effects of local block vs non block will be assessed with respect to postoperative outcomes (such as pain score, and recovery profiles) in outpatients after hand surgery.', 'detailedDescription': 'Analyzing medical records and through a telephone questionnaire, in a retrospective and prospective review respectively.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Outpatients undergoing hand surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-80 years old\n* Outpatients who underwent hand surgery under peripheral nerve block or local infiltration alone\n\nExclusion Criteria:\n\n* Patients who do not meet inclusion criteria'}, 'identificationModule': {'nctId': 'NCT01110759', 'briefTitle': 'Medical Review: Hand Surgery After Local Block Versus Non-block', 'organization': {'class': 'OTHER', 'fullName': 'Cedars-Sinai Medical Center'}, 'officialTitle': 'Retrospective Chart-review Study Involving Outpatients Who Underwent Hand Surgery With Local Anesthesia: Comparing Outcome With a Peripheral Nerve Block vs. Local Infiltration Alone', 'orgStudyIdInfo': {'id': 'Pro00019315'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Under Local Infiltration'}, {'label': 'Under Peripheral Nerve Block'}]}, 'contactsLocationsModule': {'locations': [{'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Cedars Sinai Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Ronald H Wender, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cedars-Sinai Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cedars-Sinai Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chairman, Department of Anesthesiology', 'investigatorFullName': 'Ronald Wender', 'investigatorAffiliation': 'Cedars-Sinai Medical Center'}}}}