Impact of the NeuroCuple Device on Pain Management After Cesarean Delivery

Part of paid clinical trials in Falls Church, Virginia.

Sponsor
Inova Health Care Services
Study ID
NCT07185425
Status
Recruiting
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Conditions

  • Analgesia
  • Pain
  • Pregnancy

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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

Study Details

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.

Key Dates

Start date
Oct 13, 2025
Status verified
Oct 2025
Primary completion
Sep 30, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
180 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: NeuroCuple device
    Device placed by research personnel in PACU prior to transfer to the post-partum unit
  • Sham Comparator: Sham device
    Device placed by research personnel in PACU prior to transfer to the post-partum unit
  • No Intervention: Standard of care
    No device will be placed

Primary Outcome Measure

Total Milligram Morphine Equivalents (MME) [ Time Frame: Day of surgery to postop day 4 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Inova Fairfax Medical CampusFalls ChurchVirginia22042
Antonio Saad, MD
[email protected]
703-776-6040
Michelle Cassidy, PhD, RN
[email protected]
(703) 776-4600
Antonio Saad, MD (PRINCIPAL_INVESTIGATOR)
Maggie Wong, MD (SUB_INVESTIGATOR)
Elle Murrin, MD (SUB_INVESTIGATOR)

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By research site
Inova Fairfax Medical Campus· Falls Church, VA

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