- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03369392
PANDA-Regional Feasibility Study of a Smartphone Pain Management Application
April 18, 2019 updated by: Ron Ree, University of British Columbia
The At-home Feasibility Evaluation of PANDA-Regional, a Smartphone Application Designed to Support Post-operative Pain Management in Patients Undergoing Peripheral Nerve Blocks
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
As above
Study Type
Interventional
Enrollment (Actual)
29
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
British Columbia
-
Vancouver, British Columbia, Canada, V6Z 1Y6
- St. Paul's Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Feasibility Cycle 1
Participants use the initial 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.
|
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.
|
A smartphone-based postoperative pain management tool
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
2-7 days post-operatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
2-7 days post-operatively
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- 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
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 11, 2017
Primary Completion (Actual)
March 31, 2019
Study Completion (Actual)
March 31, 2019
Study Registration Dates
First Submitted
November 28, 2017
First Submitted That Met QC Criteria
December 5, 2017
First Posted (Actual)
December 12, 2017
Study Record Updates
Last Update Posted (Actual)
April 19, 2019
Last Update Submitted That Met QC Criteria
April 18, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H16-1196
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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