TrueRelief Efficacy for Post-cesarean Pain (ELECTRON)

The Ohio State University

Status: Completed

Conditions: Post-cesarean Pain

Treatments: Device: TrueRelief device; Device: Sham TrueRelief device

Study type: Interventional

Funder types: Other

Identifiers

NCT05250830

2022H0046

Details and patient eligibility

About

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.

Enrollment: 134 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

134 participants in 2 patient groups

TrueRelief device

Experimental group

Description:

Patients receive an experimental procedure using a TrueRelief device.

Treatment:

Device: TrueRelief device

Sham TrueRelief device

Sham Comparator group

Description:

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.

Treatment:

Device: Sham TrueRelief device