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?

This trial aims to determine if a small device called Bridge, which sits on the outer ear and functions like a TENS unit, can reduce the need for pain medication after a cesarean section. The Bridge is an auricular percutaneous nerve field stimulator. Researchers seek to compare the pain medication needs of women using the Bridge device with those who do not use it. The trial includes three groups: one using the Bridge device, another using a non-functional sham device, and a third receiving only standard pain medication. Women scheduled for a cesarean section under certain conditions, such as having intact skin around the ear, might be suitable for this study. As an unphased trial, this study offers participants the chance to contribute to innovative pain management research.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, since the study aims to reduce the need for pain medication, you might be able to continue your current medications unless advised otherwise by the study team.

What prior data suggests that the Bridge device is safe for reducing postoperative pain after cesarean section?

Research shows that the Bridge device, a small tool used on the ear to stimulate nerves, safely reduces pain. Studies have found that this type of nerve stimulation effectively manages pain without major side effects. In earlier research, patients using similar devices reported less pain and experienced no serious problems. The device alters how pain signals reach the brain, reducing the sensation of pain. While the safety data from these studies is encouraging, participants should consult a healthcare provider about any concerns before joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using the Auricular Percutaneous Nerve Field Stimulator for managing postoperative pain after a cesarean section because it offers a non-drug approach to pain relief. Unlike standard pain management options that rely on medications like opioids or NSAIDs, this device targets nerve pathways by stimulating specific points on the ear. This method could potentially reduce the need for traditional pain medications, minimizing side effects and dependency risks. Additionally, it provides continuous pain relief for up to five days, which aligns with the critical recovery period postpartum.

What evidence suggests that the Bridge device is effective for reducing postoperative pain after a cesarean section?

Research has shown that using a small device like the Bridge, which stimulates nerves in the ear, can reduce post-surgery pain without medications. In this trial, participants may receive the active Bridge device, which studies have shown alters pain perception, making it less intense. Some trials found that this nerve stimulation effectively lowers the need for pain medication after surgeries, including C-sections. This method shows promise for managing post-surgery pain and could help new mothers use fewer opioids. Early results suggest that this device might improve pain management after cesarean deliveries. ^{1 2 4 6 7}

Who Is on the Research Team?

Antonio Saad, MD

Principal Investigator

Inova Health Systems

Ellen M Murrin, DO

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06434714

Management of Postoperative Pain After Cesarean ... The device is a auricular percutaneous electrical nerve stimulator that modulates pain receptors leading to reduced pain sensation. This trial study to examine ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6825521/

Auricular percutaneous nerve field stimulator device as ... The PERCEIVE trial will provide definitive data to support or refute the use of auricular PNFS as an effective adjunct to post-Cesarean delivery ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04365465

BRIDGE Percutaneous Nerve Stimulation for Cesarean Delivery ... BPI25 Survey, 1 item survey of pain medication use frequency as self-reported by participants. Scored on a 1-5 scale, with 1 indicating better outcomes and 5 ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12247084/

Percutaneous auricular neuromodulation to treat pain after ... This pilot study demonstrates that percutaneous auricular neuromodulation is a feasible approach for managing pain in ambulatory surgical procedures.

5. tandfonline.com tandfonline.com/doi/full/10.1080/17434440.2025.2474731

Percutaneous auricular neuromodulation for postoperative ... Percutaneous auricular nerve stimulation offers a promising neuromodulation technique for managing postoperative pain.

6. rapm.bmj.com rapm.bmj.com/content/early/2022/07/15/rapm-2022-103777

Percutaneous auricular nerve stimulation ... These cases demonstrate that ambulatory percutaneous auricular neuromodulation is feasible and may be an effective analgesic and decreasing or even negating ...

7. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/49/NCT03265249/Prot_SAP_000.pdf

Auricular Percutaneous Electrical Nerve Field Stimulation ( ... Preliminary, unpublished animal data indicates that neurostimulation with this device leads to a significant decrease in baseline firing of amygdala neurons and ...