NeuroCuple for pain after cesarean delivery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-center, randomized (1:1:1), sham-controlled trial will enroll 180 women undergoing non-emergent cesarean delivery and randomize them to an active NeuroCuple device, a sham device, or standard postoperative care. Devices are placed in the PACU by trained staff and both patients and clinical teams are blinded to active versus sham assignment. Pain scores will be collected during the hospital stay and daily through postoperative day 4, and total opioid consumption will be measured in morphine milligram equivalents through day 4. The trial compares pain intensity and opioid use between active device, sham, and standard care groups to determine whether the device reduces postoperative pain and medication needs.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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

Where it's running

• Inova Fairfax Medical Campus
  Falls Church, Virginia, United States Recruiting

Study contacts

• Principal investigator: Antonio Saad, MD — Inova Health Care Services
• Study coordinator: Antonio Saad, MD
• Email: antonio.saad@inova.org
• Phone: 7037766040

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.