Post Operative PainPOPSNCT03750357
Percutaneous Electrical Nerve Stimulation (PENS) of the Auricle for Post Operative Pain Solution(POPS) - Cardiac Surgery
A study testing Primary Relief v 2.0 in people with Post Operative Pain and Midline Sternotomy Incision, run by DyAnsys, Inc. at 1 site in India.
Trial summary
Percutaneous Electrical Nerve Stimulation (PENS) of the auricle for acute pain management post cardiac surgery Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Post Operative Pain, Midline Sternotomy Incision
- What is being tested?
- Primary Relief v 2.0
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIndia
- Study dates
- 11 Oct 2018to 17 Dec 2018
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cardiac surgery patient with midline sternotomy incision
Who cannot join
- Thoracotomy incisions
- Patients with pacemakers,
- Post operative cognitive dysfunction
- Anticipated ventilation > 24 hrs
- Pre operative opioid therapy
- Ear infections
- Skin lesions / allergy to adhesive materials
- Re-exploration for any reason
Trial locations and contacts
1 site in 1 country.
India1 site
Sri Jayadeva Institute of cardiovascular Science and Research
Bangalore, Karnataka, 560069
About this study
Official title: Percutaneous Electrical Nerve Stimulation (PENS) of the Auricle for Acute Pain Management Post Cardiac Surgery
Percutaneous Electrical Nerve Stimulation (PENS) of the auricle for acute pain management post cardiac surgery
Read the detailed description
A well formulated analgesic protocol is fundamental to fast tracking post cardiac surgery. Traditional analgesic methods have their own set of drawbacks unique to cardiac surgery. Opioids have well established side effects like nausea, vomiting, respiratory depression, urinary retention. Regional anesthetic techniques in anti coagulated patients may result in potentially catastrophic neurological, bleeding and thromboembolic sequelae. Non steroidal Anti Inflammatory Drugs (NSAIDs) have been associated with increased cerebrovascular events, renal dysfunction, sternal wound infections. These make alternative therapies, including non pharmacological modalities, attractive options for optimal analgesic therapy during the post operative period.
Alternative methods like topical application of COX -2 inhibitors, intravenous magnesium, Transcutaneous Electrical Nerve Stimulation (TENS) have been tried with varied results in cardiac surgery. A somatotopic relationship has been described between the auricle and the other anatomical regions of the body. When specific points are accurately identified along the meridians of the ear and stimulated electrically, analgesic effects are known to occur. Percutaneous Electrical Nerve Stimulation (PENS) of the auricle and its efficacy in management of post midline sternotomy pain has not been evaluated previously. Primary Relief v 2.0 is a device which provides continuous PENS aimed at non pharmacological post operative pain management.
- Conditions
- Post Operative Pain, Midline Sternotomy Incision
- Being tested
- Primary Relief v 2.0
- Keywords
- Cardiac surgery pain reduction, Post operative pain, PENS, Neurostimulation
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary Relief v 2.0Device
Also called Neurostimulator
To prove the effectiveness of Post Operative Pain Solution using Primary relief v 2.0 by Percutaneous Electrical Nerve Stimulation in the auricle.
| Study group | Role | What they receive |
|---|---|---|
| Primary Relief v 2.0 with Paracetamol | Experimental | Group A will be treated with Primary Relief v 2.0(1 - 100Hz) sweep stimulation with increase in power of the stimulation for fixed interval of time. Receives: Device: Primary Relief v 2.0 |
| Only Paracetamol | No intervention | Group B will be treated with paracetamol drug. |
What is being measured
The primary outcome is the main question the study is designed to answer.
PAIN Relief by physical examination by HCP
Relief of pain when the dosage of the anesthesia level gradually decreases after the surgery completion. This is measured by physical interaction with the patient by the health care provider.
Measured: After 2 hours of device activation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2018
- Study start11 Oct 2018
- Primary completion17 Nov 2018
- Study completion17 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative PainStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- DyAnsys, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rohini M Balaji, MBBS., DNB, Principal investigator, Sri Jayadeva Institue of Cardiovascular Science and Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03750357
- Sponsor's protocol ID
- PR2-POPS-18
- Other IDs
- CS/PRv2.0/01/2018
- Acronym
- POPS
- Status last verified
- Nov 2018
- First submitted
- 17 Nov 2018
- Last updated
- 4 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Electrical Nerve Stimulation (PENS) of the Auricle for Acute Pain Management Post Cardiac Surgery
- ClinicalTrials.gov ID
- NCT03750357
- Acronym / sponsor ID
- POPS / PR2-POPS-18
- Conditions
- Post Operative Pain, Midline Sternotomy Incision
- Keywords
- Cardiac surgery pain reduction, Post operative pain, PENS, Neurostimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- DyAnsys, Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Oct 2018 (actual)
- Primary completion
- 17 Nov 2018 (actual)
- Study completion
- 17 Dec 2018 (actual)
- First posted
- 23 Nov 2018 (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.
Percutaneous Electrical Nerve Stimulation (PENS) of the auricle for acute pain management post cardiac surgery
Detailed description
A well formulated analgesic protocol is fundamental to fast tracking post cardiac surgery. Traditional analgesic methods have their own set of drawbacks unique to cardiac surgery. Opioids have well established side effects like nausea, vomiting, respiratory depression, urinary retention. Regional anesthetic techniques in anti coagulated patients may result in potentially catastrophic neurological, bleeding and thromboembolic sequelae. Non steroidal Anti Inflammatory Drugs (NSAIDs) have been associated with increased cerebrovascular events, renal dysfunction, sternal wound infections. These make alternative therapies, including non pharmacological modalities, attractive options for optimal analgesic therapy during the post operative period.
Alternative methods like topical application of COX -2 inhibitors, intravenous magnesium, Transcutaneous Electrical Nerve Stimulation (TENS) have been tried with varied results in cardiac surgery. A somatotopic relationship has been described between the auricle and the other anatomical regions of the body. When specific points are accurately identified along the meridians of the ear and stimulated electrically, analgesic effects are known to occur. Percutaneous Electrical Nerve Stimulation (PENS) of the auricle and its efficacy in management of post midline sternotomy pain has not been evaluated previously. Primary Relief v 2.0 is a device which provides continuous PENS aimed at non pharmacological post operative pain management.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Primary Relief v 2.0 with Paracetamol | Experimental | Device: Primary Relief v 2.0Group A will be treated with Primary Relief v 2.0(1 - 100Hz) sweep stimulation with increase in power of the stimulation for fixed interval of time. |
| Only Paracetamol | No intervention | –Group B will be treated with paracetamol drug. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Cardiac surgery patient with midline sternotomy incision
Key exclusion criteria (8 listed)
- Thoracotomy incisions
- Patients with pacemakers,
- Post operative cognitive dysfunction
- Anticipated ventilation > 24 hrs
- Pre operative opioid therapy
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 |
|---|---|---|
| Primary Relief v 2.0Also: NeurostimulatorTo prove the effectiveness of Post Operative Pain Solution using Primary relief v 2.0 by Percutaneous Electrical Nerve Stimulation in the auricle. | Device | Primary Relief v 2.0 with Paracetamol |
Primary outcome
PAIN Relief by physical examination by HCP
Time frame: After 2 hours of device activation
Relief of pain when the dosage of the anesthesia level gradually decreases after the surgery completion. This is measured by physical interaction with the patient by the health care provider.
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 4 Feb 2019.
- 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.
Rohini M Balaji, MBBS., DNB principal investigator
Sri Jayadeva Institue of Cardiovascular Science and Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Primary Relief v 2.0 in people with Post Operative Pain and Midline Sternotomy Incision, run by DyAnsys, Inc. at 1 site in India.
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 1 inclusion and 8 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 4 Feb 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 India. 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?
PAIN Relief by physical examination by HCP (time frame: After 2 hours of device activation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Feb 2019.