TrueRelief Efficacy for Post-cesarean Pain (ELECTRON)

Study Overview
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Brief Summary
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This is a randomized trial of 134 individualized post-cesarean delivery who will be randomized to twice daily use of non-invasive bioelectronic treatment with TrueRelief device or identical appearing sham device for post-cesarean pain management.

Official Title
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Non-invasive bioELEctroniC Treatment foR pOst-cesarean paiN (ELECTRON)

Conditions
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Post-cesarean Pain

Intervention / Treatment
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* Device: TrueRelief device
* Device: Sham TrueRelief device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Post cesarean delivery (combined vaginal/cesarean deliveries are not eligible) Singleton, or twin gestation Exclusion Criteria: Known history of opioid use disorder, by medical record review Contraindication to opioids Contraindications to both acetaminophen and ibuprofen Significant surgical procedures (e.g., hysterectomy) prior to randomization as pain trajectory will be completely different Fetal or neonatal death prior to randomization Inability to randomize on postoperative day 0 Inability to participate in twice daily use of non-invasive bioelectronic treatment during inpatient stay as assessed by research staff Language barrier (non-English or Spanish speaking) Participation in another intervention study that influences the primary outcome in this trial

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Double blind, randomized, sham-controlled trial parallel arm study using TrueRelief as the experimental treatment and a TrueRelief device with sham capabilities as a placebo.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TrueRelief device<br>Patients receive an experimental procedure using a TrueRelief device. | Device: TrueRelief device<br>* TrueRelief is an FDA-cleared treatment for chronic intractable pain, and as an adjunctive procedure in the management of post-surgical and post-traumatic acute pain. This 20,000 Hz high frequency electrical procedure is provided by clinicians trained in the use of the device and delivered via handheld steel-tipped probes to the source of pain and where pain is experienced.<br>|
| Sham Comparator: Sham TrueRelief device<br>Patients receive a placebo procedure using a sham TrueRelief device that looks and operates identically to the experimental TrueRelief device but will not emit any high frequency current. | Device: Sham TrueRelief device<br>* The placebo device looks and operates identically to the experimental TrueRelief device but will not emit any high frequency current.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluating non-invasive bioelectronic treatment with TrueRelief device versus sham comparator to see the effect in decreasing opioid consumption in morphine milligram equivalents in inpatient post-cesarean population. |  | For primary day of cesarean to day of discharge (3 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluating non-invasive bioelectronic treatment with TrueRelief device versus sham comparator to see the effect in decreasing the number of opioid refill prescriptions. |  | After discharge through study completion, an average of six weeks | 
| Evaluating non-invasive bioelectronic treatment with TrueRelief device versus sham comparator to see the effect in decreasing the total number of opioid tablets prescribed at discharge. |  | At the discharge up to 24 hours | 
| Evaluating non-invasive bioelectronic treatment with TrueRelief device versus sham comparator to see the effect in decreasing post-cesarean pain intensity pain scores based on the Brief Pain Inventory (worst, average, current). |  | At the discharge up to 24 hours. | 
| Evaluating incidence of opioid related side effects. | Evaluating incidence of opioid related side effects (nausea and constipation). | After cesarean delivery until six weeks postpartum | 
| Evaluating non-invasive bioelectronic treatment with TrueRelief device versus sham comparator to see the effect in wound disruption rates. |  | After cesarean delivery until six weeks postpartum | 
| Evaluating non-invasive bioelectronic treatment with TrueRelief device versus sham comparator to see the effect in breastfeeding rates. |  | After cesarean delivery until six weeks postpartum | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Post-cesarean pain, Non-opioid, Non-invasive device