NCT03369392

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for not_applicable postoperative-pain

Timeline
Completed

Started Dec 2017

Typical duration for not_applicable postoperative-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 28, 2017

Completed
13 days until next milestone

Study Start

First participant enrolled

December 11, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 12, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2019

Completed
Last Updated

April 19, 2019

Status Verified

April 1, 2019

Enrollment Period

1.3 years

First QC Date

November 28, 2017

Last Update Submit

April 18, 2019

Conditions

Postoperative PainAnesthesia, Conduction

Outcome Measures

Primary Outcomes (1)

  • Feasibility of the PANDA application

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

    2-7 days post-operatively

Secondary Outcomes (1)

  • Identify usability issues

    2-7 days post-operatively

Study Arms (3)

Feasibility Cycle 1

EXPERIMENTAL

Participants use the initial PANDA application.

Other: Panda application

Feasibility Cycle 2

EXPERIMENTAL

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

Other: Panda application

Feasibility Cycle 3

EXPERIMENTAL

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

Other: Panda application

Interventions

Panda applicationOTHER

A smartphone-based postoperative pain management tool

Feasibility Cycle 1Feasibility Cycle 2Feasibility Cycle 3

Eligibility Criteria

Age19 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

Related Publications (1)

  • 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.

    PMID: 32500515DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Ronald Ree, MD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

  • 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

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Associate Professor

Study Record Dates

First Submitted

November 28, 2017

First Posted

December 12, 2017

Study Start

December 11, 2017

Primary Completion

March 31, 2019

Study Completion

March 31, 2019

Last Updated

April 19, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)