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Impact of the NeuroCuple Device on Pain Management After Cesarean Delivery

RecruitingNAAges 18 Years - anyFemaleInova Health Care Services
NCT07185425 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This will be a single-center, sham-controlled, 3 arms, randomized (1:1:1) prospective study in females undergoing cesarean delivery to investigate the impact of NeuroCuple™ non-pharmacological analgesic device for management of postoperative pain. The investigators hypothesize that women treated with the Neurocuple device will experience less pain and consequently require less opioid pain medication after cesarean delivery compared to women who receive standard post-surgical medication.

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📋 Eligibility rules (as published)
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
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What it tests

  • NeuroCuple
  • Sham
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Where

1 site
Inova Fairfax Medical Campus
Falls Church, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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