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PANDA-Regional Feasibility Study of a Smartphone Pain Management Application

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03369392
Recruitment Status : Completed
First Posted : December 12, 2017
Last Update Posted : April 19, 2019
Sponsor:
Information provided by (Responsible Party):
Ron Ree, University of British Columbia

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Postoperative Pain Anesthesia, Conduction Other: Panda application Not Applicable

Detailed Description:
As above

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: The At-home Feasibility Evaluation of PANDA-Regional, a Smartphone Application Designed to Support Post-operative Pain Management in Patients Undergoing Peripheral Nerve Blocks
Actual Study Start Date : December 11, 2017
Actual Primary Completion Date : March 31, 2019
Actual Study Completion Date : March 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Feasibility Cycle 1
Participants use the initial PANDA application.
Other: Panda application
A smartphone-based postoperative pain management tool

Experimental: Feasibility Cycle 2
Participants use the PANDA application after modifications are made based on suggestions from participants in cycle 1.
Other: Panda application
A smartphone-based postoperative pain management tool

Experimental: Feasibility Cycle 3
Participants use the PANDA application after modifications are made based on suggestions from participants in cycle 1 and 2.
Other: Panda application
A smartphone-based postoperative pain management tool




Primary Outcome Measures :
  1. Feasibility of the PANDA application [ Time Frame: 2-7 days post-operatively ]
    Measured by assessing the participants' compliance with the application in supporting ongoing pain assessments and analgesic administration.


Secondary Outcome Measures :
  1. Identify usability issues [ Time Frame: 2-7 days post-operatively ]
    Assessed by having participants complete a Computer Systems Usability Questionnaire (CSUQ) and a brief phone interview



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Undergoing ambulatory surgical procedures that require peripheral nerve blocks for which there is an anticipated post-surgical pain model
  • Planned post-discharge analgesic medications including non-steroidal anti-inflammatory drugs, acetaminophen and/or opioids for at least 2 days
  • ASA I-III
  • Written informed consent
  • Have a smartphone device at their disposal

Exclusion Criteria:

  • Inability or refusal to provide informed consent
  • Presence of significant cognitive impairment, visual impairments, neurological injury, or psychomotor dysfunction that impairs ability to use the app
  • Inability to follow study instructions and complete questionnaires in English

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03369392


Locations
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Canada, British Columbia
St. Paul's Hospital
Vancouver, British Columbia, Canada, V6Z 1Y6
Sponsors and Collaborators
University of British Columbia
Investigators
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Principal Investigator: Ronald Ree, MD University of British Columbia
Study Chair: Cynthia Fan, MD University of British Columbia
Study Chair: Mark Ansermino, MBBCH University of British Columbia
Study Chair: Terri Sun, MD University of British Columbia
Study Chair: Lily Yu Long Chiu, MD University of British Columbia
Study Chair: Dustin Dunsmuir University of British Columbia

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Responsible Party: Ron Ree, Clinical Associate Professor, University of British Columbia
ClinicalTrials.gov Identifier: NCT03369392     History of Changes
Other Study ID Numbers: H16-1196
First Posted: December 12, 2017    Key Record Dates
Last Update Posted: April 19, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms