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PANDA-Regional Feasibility Study of a Smartphone Pain Management Application

Primary Purpose

Postoperative Pain, Anesthesia, Conduction

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Panda application

About this trial

This is an interventional other trial for Postoperative Pain

Eligibility Criteria

19 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

St. Paul's Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Feasibility Cycle 1

Feasibility Cycle 2

Feasibility Cycle 3

Arm Description

Participants use the initial PANDA application.

Participants use the PANDA application after modifications are made based on suggestions from participants in cycle 1.

Participants use the PANDA application after modifications are made based on suggestions from participants in cycle 1 and 2.

Outcomes

Primary Outcome Measures

Feasibility of the PANDA application

Measured by assessing the participants' compliance with the application in supporting ongoing pain assessments and analgesic administration.

Secondary Outcome Measures

Identify usability issues

Assessed by having participants complete a Computer Systems Usability Questionnaire (CSUQ) and a brief phone interview

Full Information

NCT ID

NCT03369392

First Posted

November 28, 2017

Last Updated

April 18, 2019

Sponsor

University of British Columbia

1. Study Identification

Unique Protocol Identification Number

NCT03369392

Brief Title

PANDA-Regional Feasibility Study of a Smartphone Pain Management Application

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2019

Overall Recruitment Status

Completed

Study Start Date

December 11, 2017 (Actual)

Primary Completion Date

March 31, 2019 (Actual)

Study Completion Date

March 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of British Columbia

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

Detailed Description

As above

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postoperative Pain, Anesthesia, Conduction

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Sequential Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

29 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Feasibility Cycle 1

Arm Type

Experimental

Arm Description

Participants use the initial PANDA application.

Arm Title

Feasibility Cycle 2

Arm Type

Experimental

Arm Description

Participants use the PANDA application after modifications are made based on suggestions from participants in cycle 1.

Arm Title

Feasibility Cycle 3

Arm Type

Experimental

Arm Description

Participants use the PANDA application after modifications are made based on suggestions from participants in cycle 1 and 2.

Intervention Type

Other

Intervention Name(s)

Panda application

Intervention Description

A smartphone-based postoperative pain management tool

Primary Outcome Measure Information:

Title

Feasibility of the PANDA application

Description

Measured by assessing the participants' compliance with the application in supporting ongoing pain assessments and analgesic administration.

Time Frame

2-7 days post-operatively

Secondary Outcome Measure Information:

Title

Identify usability issues

Description

Assessed by having participants complete a Computer Systems Usability Questionnaire (CSUQ) and a brief phone interview

Time Frame

2-7 days post-operatively

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ronald Ree, MD

Organizational Affiliation

University of British Columbia

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Cynthia Fan, MD

Organizational Affiliation

University of British Columbia

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Mark Ansermino, MBBCH

Organizational Affiliation

University of British Columbia

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Terri Sun, MD

Organizational Affiliation

University of British Columbia

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Lily Yu Long Chiu, MD

Organizational Affiliation

University of British Columbia

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Dustin Dunsmuir

Organizational Affiliation

University of British Columbia

Official's Role

Study Chair

Facility Information:

Facility Name

St. Paul's Hospital

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V6Z 1Y6

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

32500515

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.

Results Reference

derived

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PANDA-Regional Feasibility Study of a Smartphone Pain Management Application

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