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Impact of the NeuroCuple Device on Pain Management After Cesarean Delivery

NCT07185425 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2025-10-16

No results posted yet for this study

Summary

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.

Conditions

  • Pain
  • Analgesia
  • Pregnancy

Interventions

DEVICE

NeuroCuple

Device around the abdomen over c-section bandages in the PACU

DEVICE

Sham

Device around the abdomen over c-section bandages in the PACU

Sponsors & Collaborators

  • nCap Medical

    collaborator INDUSTRY

  • Inova Health Care Services

    lead OTHER

Principal Investigators

  • Antonio Saad, MD · Inova Health Care Services

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-13
Primary Completion
2027-09-30
Completion
2027-09-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07185425 on ClinicalTrials.gov