NeuroCuple Device for Pain After Cesarean Delivery

This study is looking at how a device called NeuroCuple™ might help manage pain after a cesarean delivery (C-section). Researchers want to see if women who use the NeuroCuple device need less opioid pain medication compared to those who receive standard care. The NeuroCuple device is placed around the abdomen over C-section bandages. You might be able to join if you are a woman aged 18 or older, are having a planned or unplanned C-section, and have intact skin around the incision area. The study will measure the total amount of opioid pain medication you use from the day of surgery until four days after. The current recruitment status is unclear.

Study design
This is a randomized study with 180 participants, meaning you would be randomly assigned to one of three groups: the active device, a sham device (looks like the active device but doesn't work), or standard care. Both you and the medical team would not know if you received the active or sham device.
What's involved
If you join, the device would be placed in the recovery room after your C-section. Your pain scores would be collected while you are in the hospital and daily after you go home until four days after surgery.
Compensation
Not stated in the trial record.
Follow-up
Your pain medication use will be tracked from the day of surgery until four days after surgery.

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NCT07185425

Impact of the NeuroCuple Device on Pain Management After Cesarean Delivery

Recruiting
NAAges 18+InterventionalTreatment
Inova Health Care Services
~180 participants
Updated 2025-10-16 on ClinicalTrials.gov
What's tested:NeuroCupleSham

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Total Milligram Morphine Equivalents (MME)
Measured over Day of surgery to postop day 4
Pain
Analgesia
Pregnancy
1 sites across 1 states
Virginia1
  • Antonio Saad, MD · PRINCIPAL_INVESTIGATOR · Inova Health Care Services

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Eligibility criteria

Inclusion

Female 18 years or older able to provide informed consent in English or Spanish
Scheduled for a planned or unplanned non-emergent cesarean delivery under neuraxial anesthesia
Intact skin surfaces around the operative skin incision area at the site of patch application
Pfannestiel skin incision

Exclusion

Active drug abuse
Chronic opioid user
Severe chronic pain
Psoriasis vulgaris or other skin conditions precluding safe device application
Subject is concurrently participating in another research study with an investigational drug or medical device that in the Investigator's opinion could impact subject safety or study results
Subject with reasons to maintain an epidural beyond operative room
Subject with complex surgery or subject who may need more than a cesarean surgery with possible tubal sterilization procedure
Subject is deemed not suitable for the study at the discretion of the principal Investigator
  • Total Milligram Morphine Equivalents (MME)Day of surgery to postop day 4

    Total opioid intake in MME on postoperative days 4 or before discharge.