Postoperative PainNCT03369392
PANDA-Regional Feasibility Study of a Smartphone Pain Management Application
A study testing Panda application in people with Postoperative Pain and Anesthesia, Conduction, run by University of British Columbia at 1 site in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 19 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain, Anesthesia, Conduction
- What is being tested?
- Panda application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteCanada
- Study dates
- 11 Dec 2017to 31 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed description
As above
- Conditions
- Postoperative Pain, Anesthesia, Conduction
- Being tested
- Panda application
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Panda applicationOther
A smartphone-based postoperative pain management tool
| Study group | Role | What they receive |
|---|---|---|
| Feasibility Cycle 1 | Experimental | Participants use the initial PANDA application. Receives: Other: Panda application |
| Feasibility Cycle 2 | Experimental | Participants use the PANDA application after modifications are made based on suggestions from participants in cycle 1. Receives: 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. Receives: Other: Panda application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of the PANDA application
Measured by assessing the participants' compliance with the application in supporting ongoing pain assessments and analgesic administration.
Measured: 2-7 days post-operatively
Secondary outcomes (1)
Identify usability issues
Assessed by having participants complete a Computer Systems Usability Questionnaire (CSUQ) and a brief phone interview
Measured: 2-7 days post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2017
- Study start11 Dec 2017
- Primary completion31 Mar 2019
- Study completion31 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ron Ree, University of British Columbia
- Investigators
- Ronald Ree, MD, Principal investigator, University of British ColumbiaCynthia Fan, MD, Study chair, University of British ColumbiaMark Ansermino, MBBCH, Study chair, University of British ColumbiaTerri Sun, MD, Study chair, University of British ColumbiaLily Yu Long Chiu, MD, Study chair, University of British ColumbiaDustin Dunsmuir, Study chair, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03369392
- Sponsor's protocol ID
- H16-1196
- Status last verified
- Apr 2019
- First submitted
- 28 Nov 2017
- Last updated
- 19 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32500515
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03369392
- Acronym / sponsor ID
- H16-1196
- Conditions
- Postoperative Pain, Anesthesia, Conduction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 11 Dec 2017 (actual)
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 12 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Feasibility Cycle 1 | Experimental | Other: Panda applicationParticipants use the initial PANDA application. |
| Feasibility Cycle 2 | Experimental | Other: Panda applicationParticipants use the PANDA application after modifications are made based on suggestions from participants in cycle 1. |
| Feasibility Cycle 3 | Experimental | Other: Panda applicationParticipants use the PANDA application after modifications are made based on suggestions from participants in cycle 1 and 2. |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Panda applicationA smartphone-based postoperative pain management tool | Other | Feasibility Cycle 1, Feasibility Cycle 2, Feasibility Cycle 3 |
Primary outcome
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.
1 secondary outcome
Identify usability issues
Time frame: 2-7 days post-operatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2019.
- Derived from this study: PubMed 32500515Dotto 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronald Ree, MD principal investigator
University of British Columbia
Cynthia Fan, MD study chair
University of British Columbia
Mark Ansermino, MBBCH study chair
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Panda application in people with Postoperative Pain and Anesthesia, Conduction, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the PANDA application (time frame: 2-7 days post-operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03369392, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2019.