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RECRUITING Not applicable ClinicalTrials.gov

Impact of the NeuroCuple Device on Pain Management After Cesarean Delivery

Sponsor: Inova Health Care Services • ClinicalTrials.gov ID: NCT07185425

Registry updated: 2026-10-20
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Description

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.

Interventions

  • NeuroCuple (Device)
    Device around the abdomen over c-section bandages in the PACU
  • Sham (Device)
    Device around the abdomen over c-section bandages in the PACU

Eligibility criteria

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

Conditions

Pain Analgesia Pregnancy

Locations

  • Inova Fairfax Medical Campus — Falls Church, Virginia, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record