Nerve Stimulation for Postoperative Pain After Cesarean Section

Overseen By Antonio Saad, MD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Inova Fairfax Hospital

Must not be taking: Opioids

Disqualifiers: Active drug abuse, Chronic pain, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 5 days

What You Need to Know Before You Apply

What is the purpose of this trial?

Post-cesarean section (CS) pain is commonly treated with acetaminophen, ibuprofen, and opioid medications as needed following delivery. About 300,000 women annually who were exposed to opioids after CS will go on to use opioids chronically. Reducing the quantity of post-CS opioids has been shown to decrease the amount of opioids used without compromising pain control. Bridge is a small device that sits on the outer ear and works similarly to a transcutaneous electrical nerve stimulation (TENS) unit to decrease pain sensation without medications. It has been shown to effectively reduce pain to decrease medication requirements after surgeries. This study aims to see if women receiving the Bridge device use need less pain medication than those without the device.

Who Is on the Research Team?

Ellen M Murrin, DO

Principal Investigator

Inova Health Systems

Antonio Saad, MD

Principal Investigator

Inova Health Systems

Are You a Good Fit for This Trial?

This trial is for women who have just had a cesarean delivery and are experiencing postoperative pain. It's aimed at those interested in managing pain with fewer opioids to reduce the risk of chronic use.

Inclusion Criteria

I am scheduled for a C-section with spinal or epidural anesthesia.

The skin behind and around my ear is healthy and undamaged.

Exclusion Criteria

Chronic opioid user

Hemophilia

Previous history of sensitivity to compound benzoin tincture

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either the Bridge device, a sham device, or standard of care pain medications post-cesarean delivery

5 days

In-patient stay post-cesarean

Follow-up

Participants are monitored for opioid intake and pain management effectiveness

4 days

Postpartum Monitoring

Participants are followed through the postpartum period to assess long-term pain management and opioid use

Up to 8 days

What Are the Treatments Tested in This Trial?

Interventions

• Auricular Percutaneous Nerve Field Stimulator

Trial Overview The study tests a device called Bridge, which is placed on the ear and may help control pain without drugs, against a sham (fake) device. The goal is to see if using Bridge reduces the need for opioid medication after cesarean section.

How Is the Trial Designed?

Group I: Bridge device Active Control 1 Intervention

Bridge device placed in post-anesthesia care unit (PACU) and worn until end-of-life of the device (at 5 days) in addition to standard of care pain medications as per institutional policy

Group II: Standard of care Active Control 1 Intervention

Standard of care pain medications only as per institutional policy

Group III: Sham device Placebo Group 1 Intervention

Sham (non-functional) Bridge device placed in post-anesthesia care unit (PACU) and worn until 5 days post-delivery in addition to standard of care pain medications as per institutional policy

Who Is Running the Clinical Trial?

Inova Fairfax Hospital

Lead Sponsor

Trials

12

Recruited

7,700+

Inova Health Care Services

Lead Sponsor

Trials

80

Recruited

22,700+