Clinical trial NCT05250830: TrueRelief Efficacy for Post-cesarean Pain (ELECTRON)
Official title: Non-invasive bioELEctroniC Treatment foR pOst-cesarean paiN (ELECTRON)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-cesarean Pain
Keywords: Post-cesarean pain
Non-opioid
Non-invasive device
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: TrueRelief, LLC
First posted: 2022-02-22
Enrollment: 134
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Median of Total Inpatient Oral Opioids Consumption (in Morphine Milligram Equivalents) in Treatment With TrueRelief Device Versus Sham Comparator Groups.
timeFrame: For primary day of cesarean to day of discharge (3 days)
Secondary outcomes:
measure: Number of Participants Who Received Opioid Refill Prescription in Non-invasive Bioelectronic Treatment With TrueRelief Device Versus Sham Comparator Groups After Discharge.
timeFrame: After discharge through study completion, an average of six weeks
measure: Morphine Milligram Equivalents (MME) Opioid Tablets Prescribed at Discharge in Non-invasive Bioelectronic Treatment With TrueRelief Device Versus Sham Comparator Groups.
timeFrame: At the discharge up to 24 hours
measure: Number of Participants With Pain Scores of Greater Than 4 (BPI Score >4) at Discharge.
timeFrame: At the discharge up to 24 hours.
measure: Rate of Wound Infection or Separation in Non-invasive Bioelectronic Treatment With TrueRelief Device Versus Sham Comparator Groups.
timeFrame: After cesarean delivery until six weeks postpartum
measure: Breastfeeding Rates in Non-invasive Bioelectronic Treatment With TrueRelief Device Versus Sham Comparator Groups.
timeFrame: At hospital discharge
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine
state: Ohio
Study officials:
References: