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Completed

NCT Number: NCT05250830

TrueRelief Efficacy for Post-cesarean Pain (ELECTRON)

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.

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Key information

Conditions

Post-cesarean Pain

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Columbus, Ohio, 43210, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TrueRelief device

Device

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 device

Device

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

Primary outcomes

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

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

    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.

Secondary outcomes

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

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

    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.

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

    Time frame: At the discharge up to 24 hours

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

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

    Time frame: At the discharge up to 24 hours.

    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,

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

    Time frame: After cesarean delivery until six weeks postpartum

    Rate of wound infection or separation in non-invasive bioelectronic treatment with TrueRelief device versus sham comparator groups.

  5. Breastfeeding Rates in Non-invasive Bioelectronic Treatment With TrueRelief Device Versus Sham Comparator Groups.

    Time frame: At hospital discharge

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Collaborators

  • TrueRelief, LLC

Registry information

Official study title

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

Acronym: ELECTRON

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 22, 2022
Registry last updated
Jun 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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