Pain, Postoperative
Conditions
Keywords
Colorectal Surgery, transcutaneous electric nerve stimulation
Brief summary
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.
Interventions
DEVICEPercutaneous 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.
DEVICESham percutaneous auricular neurostimulation
Identical in appearance to active, device, but no stimulation will be given.
Sponsors
Medical College of Wisconsin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* elective colon surgery * age over 18 years * provide informed consent
Exclusion criteria
* emergency surgery * history of opioid dependence/use, anxiety with anxiolytic use * planned ICU admission postoperatively * adhesive allergy/sensitivity * other medical contraindications
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Narcotic Consumption During Hospital Stay | 5 days | Total inpatient narcotic use measured in oral morphine equivalents per day (OME) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 28 |
| 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. | 25 |
| Total | 53 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Active | Inactive | Total |
|---|---|---|---|
| Age, Continuous | 56.05 years STANDARD_DEVIATION 11.266 | 61.49 years STANDARD_DEVIATION 11.273 | 58.77 years STANDARD_DEVIATION 11.248 |
| Open vs Laparoscopic Technique Laparoscopic | 26 Participants | 17 Participants | 43 Participants |
| Open vs Laparoscopic Technique Open | 2 Participants | 7 Participants | 9 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 28 participants | 24 participants | 52 participants |
| Sex: Female, Male Female | 14 Participants | 9 Participants | 23 Participants |
| Sex: Female, Male Male | 14 Participants | 15 Participants | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 28 | 0 / 24 |
| other Total, other adverse events | 0 / 28 | 0 / 24 |
| serious Total, serious adverse events | 1 / 28 | 1 / 24 |
Outcome results
Primary
Total Narcotic Consumption During Hospital Stay
Total inpatient narcotic use measured in oral morphine equivalents per day (OME)
Time frame: 5 days
Population: 1 participant withdrew before device was applied and data not collected for analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active | Total Narcotic Consumption During Hospital Stay | 90.79 Oral Morphine Equivalents per day (OME) | Standard Deviation 54.93 |
| Inactive | Total Narcotic Consumption During Hospital Stay | 90.30 Oral Morphine Equivalents per day (OME) | Standard Deviation 43.03 |
p-value: 0.97t-test, 2 sided