TrueRelief Efficacy for Post-cesarean Pain (ELECTRON)

Ohio State University134 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

134

Conditions

Post-cesarean Pain

Interventions

TrueRelief deviceDEVICE

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.

Sham TrueRelief deviceDEVICE

The placebo device looks and operates identically to the experimental TrueRelief device but will not emit any high frequency current.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

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

Locations (1)

The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine

Columbus, Ohio, United States

Outcomes

Primary Outcomes

Median of Total Inpatient Oral Opioids Consumption (in Morphine Milligram Equivalents) in Treatment With TrueRelief Device Versus Sham Comparator Groups.

The primary outcome is the total postoperative opioid intake through hospital discharge. All opioid doses were converted to equianalgesic doses of morphine sulfate MME using standard ratios.

Time frame: For primary day of cesarean to day of discharge (3 days)

Secondary Outcomes

Number of Participants Who Received Opioid Refill Prescription in Non-invasive Bioelectronic Treatment With TrueRelief Device Versus Sham Comparator Groups After Discharge.

Additional opioid prescriptions within 6 weeks postpartum in non-invasive bioelectronic treatment with TrueRelief device versus sham comparator to see the effect in decreasing the number of opioid refill prescriptions.

Time frame: After discharge through study completion, an average of six weeks

Morphine Milligram Equivalents (MME) Opioid Tablets Prescribed at Discharge in Non-invasive Bioelectronic Treatment With TrueRelief Device Versus Sham Comparator Groups.

Oral opioid prescribed at discharge as Morphine milligram equivalents (MME) in non-invasive bioelectronic treatment with TrueRelief device versus sham comparator.

Time frame: At the discharge up to 24 hours

Number of Participants With Pain Scores of Greater Than 4 (BPI Score >4) at Discharge.

The Brief Pain Inventory (BPI) includes self-assessment of pain scores in the previous 24 hours using a numerical scale from 0 to 10, with 0 representing no pain and 10 the worst pain imaginable. Moderate to severe pain (BPI score \>4) in past 24 h,

Time frame: At the discharge up to 24 hours.

Rate of Wound Infection or Separation in Non-invasive Bioelectronic Treatment With TrueRelief Device Versus Sham Comparator Groups.

Data from ClinicalTrials.gov

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