Ignite Creation Date:
2025-12-24 @ 3:42 PM
Ignite Modification Date:
2026-02-22 @ 4:53 PM
Study NCT ID:
NCT03369392
Status:
COMPLETED
Last Update Posted:
2019-04-19
First Post:
2017-11-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PANDA-Regional Feasibility Study of a Smartphone Pain Management Application
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-12-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2019-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-18', 'studyFirstSubmitDate': '2017-11-28', 'studyFirstSubmitQcDate': '2017-12-05', 'lastUpdatePostDateStruct': {'date': '2019-04-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of the PANDA application', 'timeFrame': '2-7 days post-operatively', 'description': "Measured by assessing the participants' compliance with the application in supporting ongoing pain assessments and analgesic administration."}], 'secondaryOutcomes': [{'measure': 'Identify usability issues', 'timeFrame': '2-7 days post-operatively', 'description': 'Assessed by having participants complete a Computer Systems Usability Questionnaire (CSUQ) and a brief phone interview'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postoperative Pain', 'Anesthesia, Conduction']}, 'referencesModule': {'references': [{'pmid': '32500515', 'type': 'DERIVED', 'citation': 'Dotto A, Dunsmuir D, Sun T, Chiu LYL, Ree R, Ansermino JM, Yarnold CH. The use of the Panda-Nerve Block pain app in single-shot peripheral nerve block patients: a feasibility study. Can J Anaesth. 2020 Sep;67(9):1140-1151. doi: 10.1007/s12630-020-01732-2. Epub 2020 Jun 4.'}]}, 'descriptionModule': {'briefSummary': "Despite the numerous benefits of peripheral nerve blocks (PNBs) over general anesthesia (GA) in a variety of surgical procedures, PNBs can be associated with increased post-operative pain if pain medications are not taken correctly (titrated). Unfortunately, this is a common occurrence as patients often have difficulty titrating medications in the absence of direct medical care. PANDA, a smartphone-based postoperative pain management tool, is designed to address this issue by helping patients manage their pain medications. The purpose of this study is to demonstrate the feasibility of this application in patients who are discharged after receiving PNBs. The goal is to identify areas of improvement for the application itself. It is hypothesize that PANDA will be successful in supporting patients' postoperative pain management.", 'detailedDescription': 'As above'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Undergoing ambulatory surgical procedures that require peripheral nerve blocks for which there is an anticipated post-surgical pain model\n* Planned post-discharge analgesic medications including non-steroidal anti-inflammatory drugs, acetaminophen and/or opioids for at least 2 days\n* ASA I-III\n* Written informed consent\n* Have a smartphone device at their disposal\n\nExclusion Criteria:\n\n* Inability or refusal to provide informed consent\n* Presence of significant cognitive impairment, visual impairments, neurological injury, or psychomotor dysfunction that impairs ability to use the app\n* Inability to follow study instructions and complete questionnaires in English'}, 'identificationModule': {'nctId': 'NCT03369392', 'briefTitle': 'PANDA-Regional Feasibility Study of a Smartphone Pain Management Application', 'organization': {'class': 'OTHER', 'fullName': 'University of British Columbia'}, 'officialTitle': 'The At-home Feasibility Evaluation of PANDA-Regional, a Smartphone Application Designed to Support Post-operative Pain Management in Patients Undergoing Peripheral Nerve Blocks', 'orgStudyIdInfo': {'id': 'H16-1196'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Feasibility Cycle 1', 'description': 'Participants use the initial PANDA application.', 'interventionNames': ['Other: Panda application']}, {'type': 'EXPERIMENTAL', 'label': 'Feasibility Cycle 2', 'description': 'Participants use the PANDA application after modifications are made based on suggestions from participants in cycle 1.', 'interventionNames': ['Other: Panda application']}, {'type': 'EXPERIMENTAL', 'label': 'Feasibility Cycle 3', 'description': 'Participants use the PANDA application after modifications are made based on suggestions from participants in cycle 1 and 2.', 'interventionNames': ['Other: Panda application']}], 'interventions': [{'name': 'Panda application', 'type': 'OTHER', 'description': 'A smartphone-based postoperative pain management tool', 'armGroupLabels': ['Feasibility Cycle 1', 'Feasibility Cycle 2', 'Feasibility Cycle 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V6Z 1Y6', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': "St. Paul's Hospital", 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}], 'overallOfficials': [{'name': 'Ronald Ree, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of British Columbia'}, {'name': 'Cynthia Fan, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of British Columbia'}, {'name': 'Mark Ansermino, MBBCH', 'role': 'STUDY_CHAIR', 'affiliation': 'University of British Columbia'}, {'name': 'Terri Sun, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of British Columbia'}, {'name': 'Lily Yu Long Chiu, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of British Columbia'}, {'name': 'Dustin Dunsmuir', 'role': 'STUDY_CHAIR', 'affiliation': 'University of British Columbia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of British Columbia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Associate Professor', 'investigatorFullName': 'Ron Ree', 'investigatorAffiliation': 'University of British Columbia'}}}}