Status:
COMPLETED
TrueRelief Efficacy for Post-cesarean Pain (ELECTRON)
Lead Sponsor:
Ohio State University
Collaborating Sponsors:
TrueRelief, LLC
Conditions:
Post-cesarean Pain
Eligibility:
FEMALE
18-50 years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- • Post cesarean delivery (combined vaginal/cesarean deliveries are not eligible) Singleton, or twin gestation
Exclusion
- 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
Key Trial Info
Start Date :
April 18 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 16 2023
Estimated Enrollment :
134 Patients enrolled
Trial Details
Trial ID
NCT05250830
Start Date
April 18 2022
End Date
April 16 2023
Last Update
June 6 2024
Active Locations (1)
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1
The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine
Columbus, Ohio, United States, 43210