Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2026-02-25 @ 4:15 AM
Study NCT ID:
NCT02112006
Status:
COMPLETED
Last Update Posted:
2016-03-22
First Post:
2014-04-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparing Two Injection Sites of Local Anesthetic for Hand Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006230', 'term': 'Hand Injuries'}, {'id': 'D014954', 'term': 'Wrist Injuries'}, {'id': 'D005383', 'term': 'Finger Injuries'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D001134', 'term': 'Arm Injuries'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002045', 'term': 'Bupivacaine'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-21', 'studyFirstSubmitDate': '2014-04-08', 'studyFirstSubmitQcDate': '2014-04-09', 'lastUpdatePostDateStruct': {'date': '2016-03-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-04-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'time to complete injection', 'timeFrame': 'up to 30 minutes', 'description': 'difference between the end of injection time and the beginning'}], 'primaryOutcomes': [{'measure': 'success of block', 'timeFrame': 'up to 30 minutes after injection', 'description': 'number of participants that needed additional anesthesia'}], 'secondaryOutcomes': [{'measure': 'pain scores', 'timeFrame': 'up to 10 days after surgery', 'description': 'change in pain scores'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['hand surgery', 'wrist surgery', 'finger surgery', 'anesthesia', 'regional anesthesia', 'postoperative pain'], 'conditions': ['Hand Injury', 'Wrist Injury', 'Finger Injury']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare two different injection sites for local anesthesia in patients having hand surgery. The hypothesis is that subjects receiving injections around the three nerves of the forearm will provide faster pain control and greater patient satisfaction than patients having one injection closer to the shoulder.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients ≥ 18 years of age undergoing unilateral hand, wrist, or finger surgery\n* Ability to understand and provide informed consent\n* American Society of Anesthesiologists (ASA) status I-III\n\nExclusion Criteria:\n\n* Patient refusal or inability to provide informed consent\n* True allergy, not sensitivity, to any of the following substances: Local Anesthetics, Midazolam, Fentanyl, Hydromorphone, Propofol\n* Pregnancy\n* Severe hepatic impairment\n* Evidence of infection at or near the proposed needle insertion site\n* Any sensorimotor deficit of the ipsilateral upper extremity, whether acute or chronic, as determined by the PI and designee\n* Pulmonary disease of any kind that is uncontrolled or severe in nature\n* Chronic pain patients, defined as someone diagnosed with chronic pain or a chronic pain condition, under the care of a chronic pain physician, or taking oral/intravenous narcotics consistently for 30 days prior to surgery'}, 'identificationModule': {'nctId': 'NCT02112006', 'briefTitle': 'Comparing Two Injection Sites of Local Anesthetic for Hand Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Ochsner Health System'}, 'officialTitle': 'A Comparison Of Distal Peripheral Nerve Blockade Versus Traditional Proximal Approaches For Hand Surgery', 'orgStudyIdInfo': {'id': 'Soberon Forearm'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'distal injection', 'description': '0.5% bupivacaine injected in the forearm', 'interventionNames': ['Procedure: 0.5% bupivacaine injected in the forearm']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'proximal injection', 'description': '20-30ml of 0.5% bupivacaine', 'interventionNames': ['Procedure: 20-30ml of 0.5% bupivacaine.']}], 'interventions': [{'name': '0.5% bupivacaine injected in the forearm', 'type': 'PROCEDURE', 'description': 'Median, Ulnar, and Radial nerve blocks performed in the forearm', 'armGroupLabels': ['distal injection']}, {'name': '20-30ml of 0.5% bupivacaine.', 'type': 'PROCEDURE', 'description': 'supraclavicular, infraclavicular, or axillary nerve block using 20-30ml of 0.5% bupivacaine.', 'armGroupLabels': ['proximal injection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70121', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Ochsner Clinic Foundation', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}], 'overallOfficials': [{'name': 'Jose Soberon, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ochsner Health System'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jose Soberon, MD', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Anesthesiologist', 'investigatorFullName': 'Jose Soberon, MD', 'investigatorAffiliation': 'Ochsner Health System'}}}}