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Pain after surgery is unavoidable, and opioid medications are the cornerstone of most pain management regimens. However, they come at a cost with profound impacts on gastrointestinal motility, respiratory depression, and even long-term dependence. Stimulating the external ear with cutaneous electrical current is similar to acupuncture and could help improve postoperative pain. The Bridge device (manufactured by Key Electronics [Jeffersonville, IN, USA] and distributed by Innovative Health Solutions [Versailles, IN, USA]), has been used with success in treating opioid withdrawal and in animal studies has shown increases in pain thresholds. The investigators propose a prospective, randomized, placebo-controlled, double-blinded trial to evaluate if auricular neurostimulation improves postoperative pain and reduces opioid requirements for patients undergoing elective colon surgery.
pain perception in post-operative patients may be modulated via the auricular branch of the vagus nerve. This has the potential to reduce the use of opioid medications, which will in turn reduce the incidence of postoperative ileus and reduce patient need for and dependence on narcotic pain medications. This would have an enormous economic impact due to decreased length of hospital stays for patients who undergo abdominal surgery. In addition, opioid reduction could potentially lessen the national crisis of opioid addiction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Stimulation | Experimental | Participants will have active percutaneous auricular neurostimulation for 5 days during and after elective surgery. |
|
| Sham Percutaneous Neurostimulation | Sham Comparator | Participants will have inactive device worn for 5 days during and after elective surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Percutaneous auricular neurostimulation | Device | The Bridge device (manufactured by Key Electronics [Jeffersonville, IN, USA] and distributed by Innovative Health Solutions [Versailles, IN, USA]) provides continual neurostimulation for five days with alternating current. |
| Measure | Description | Time Frame |
|---|---|---|
| Total Narcotic Consumption During Hospital Stay | Total inpatient narcotic use measured in oral morphine equivalents per day (OME) | 5 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical College of Wisconsin - Froedtert Hospital | Milwaukee | Wisconsin | 53226 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33417346 | Derived | Blank JJ, Liu Y, Yin Z, Spofford CM, Ridolfi TJ, Ludwig KA, Otterson MF, Peterson CY. Impact of Auricular Neurostimulation in Patients Undergoing Colorectal Surgery with an Enhanced Recovery Protocol: A Pilot Randomized, Controlled Trial. Dis Colon Rectum. 2021 Feb 1;64(2):225-233. doi: 10.1097/DCR.0000000000001752. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Active | Participants will have active percutaneous auricular neurostimulation for 5 days during and after elective surgery. Percutaneous auricular neurostimulation: The Bridge device (manufactured by Key Electronics [Jeffersonville, IN, USA] and distributed by Innovative Health Solutions [Versailles, IN, USA]) provides continual neurostimulation for five days with alternating current. |
| FG001 | Inactive | Participants will have inactive device worn for 5 days during and after elective surgery. Sham percutaneous auricular neurostimulation: Identical in appearance to active, device, but no stimulation will be given. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Active | Participants will have active percutaneous auricular neurostimulation for 5 days during and after elective surgery. Percutaneous auricular neurostimulation: The Bridge device (manufactured by Key Electronics [Jeffersonville, IN, USA] and distributed by Innovative Health Solutions [Versailles, IN, USA]) provides continual neurostimulation for five days with alternating current. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 1 participant withdrew before device was applied and data not collected for analysis |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Total Narcotic Consumption During Hospital Stay | Total inpatient narcotic use measured in oral morphine equivalents per day (OME) | 1 participant withdrew before device was applied and data not collected for analysis. | Posted | Mean | Standard Deviation | Oral Morphine Equivalents per day (OME) | 5 days |
|
30 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active | Participants will have active percutaneous auricular neurostimulation for 5 days during and after elective surgery. Percutaneous auricular neurostimulation: The Bridge device (manufactured by Key Electronics [Jeffersonville, IN, USA] and distributed by Innovative Health Solutions [Versailles, IN, USA]) provides continual neurostimulation for five days with alternating current. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stroke | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Carrie Y. Peterson, MD, MS | Medical College of Wisconsin | 414-955-5783 | cypeterson@mcw.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 4, 2016 | Apr 12, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 4, 2016 | Apr 12, 2019 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 2, 2018 | Apr 12, 2019 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| Sham percutaneous auricular neurostimulation | Device | Identical in appearance to active, device, but no stimulation will be given. |
|
| BG001 | Inactive | Participants will have inactive device worn for 5 days during and after elective surgery. Sham percutaneous auricular neurostimulation: Identical in appearance to active, device, but no stimulation will be given. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | 1 participant withdrew before device was applied and data not collected for analysis | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | 1 participant withdrew before device was applied and data not collected for analysis | Number | participants |
|
| Open vs Laparoscopic Technique | 1 participant withdrew before device was applied and data not collected for analysis | Count of Participants | Participants |
|
Participants will have inactive device worn for 5 days during and after elective surgery. Sham percutaneous auricular neurostimulation: Identical in appearance to active, device, but no stimulation will be given. |
|
|
|
| 0 |
| 28 |
| 1 |
| 28 |
| 0 |
| 28 |
| EG001 | Inactive | Participants will have inactive device worn for 5 days during and after elective surgery. Sham percutaneous auricular neurostimulation: Identical in appearance to active, device, but no stimulation will be given. | 0 | 24 | 1 | 24 | 0 | 24 |
| GI Bleeding | Gastrointestinal disorders | Systematic Assessment |
|
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |