Trials
Search / Trial NCT06434714

Management of Postoperative Pain After Cesarean Delivery Using Bridge Auricular Percutaneous Nerve Field Stimulator

Launched by INOVA HEALTH CARE SERVICES · May 23, 2024

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Trial Information

Current as of March 13, 2025

Withdrawn

Keywords

Cesarean Section Post Operative Pain Opioid Abuse Non Pharmacologic Therapy

ClinConnect Summary

Cesarean delivery is one of the most performed surgeries in the U.S. with approximately 1.15 million surgeries performed annually. Despite this, postoperative pain management remains a challenge. Prescribed total milligram morphine equivalents (MMEs) can range from 25 MMEs (equivalent to 3.3 oxycodone 5-mg tablets) to 1,950 MMEs (equivalent to 260 oxycodone 5-mg tablets). Additionally, the post discharge analgesia prescription is not correlated with the 24-hour predischarge opioid use or pain score. Most U.S. women who are prescribed opioids after a cesarean delivery receive at least 10 mor...

Gender

FEMALE

Eligibility criteria

  • Inclusion Criteria:
  • • Female 18 years or older able to provide informed consent in English or Spanish.
  • • Scheduled for cesarean delivery under neuraxial anesthesia.
  • • Intact skin surface behind and around the ear at the site of electrode application.
  • Exclusion Criteria:
  • • Active drug abuse.
  • • Chronic opioid user.
  • • Severe chronic pain.
  • • Hemophilia.
  • • Cardiac pacemaker or implantable electronic devices.
  • • Psoriasis vulgaris or other skin conditions precluding safe device application.
  • • Previous history of sensitivity to compound benzoin tincture.
  • • Hearing aid precluding proper placement of the device or removing which interferes with their hearing ability.
  • • 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.

Trial Officials

Antonio Saad, MD

Principal Investigator

Inova Health Systems

Ellen M Murrin, DO

Principal Investigator

Inova Health Systems

About Inova Health Care Services

Inova Health Care Services is a leading healthcare organization dedicated to providing high-quality, patient-centered care across a comprehensive range of medical specialties. With a commitment to advancing clinical research and innovation, Inova actively sponsors and conducts clinical trials aimed at improving health outcomes and enhancing treatment options for patients. The organization combines state-of-the-art facilities, a skilled team of medical professionals, and a robust research infrastructure to facilitate groundbreaking studies that address pressing health challenges. Through its dedication to excellence in clinical research, Inova Health Care Services strives to contribute to the evolving landscape of healthcare and improve the lives of individuals in the communities it serves.

Locations

Falls Church, Virginia, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0