NeuroCuple Device for Pain
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines a new device called the NeuroCuple to help manage pain after a cesarean delivery. Researchers aim to determine if this device can reduce the need for opioid pain medicine compared to usual care. Participants will either use the NeuroCuple device, a sham device (which looks like the treatment but does nothing), or receive standard care without any device. Women eligible for this trial are those scheduled for a non-emergency C-section and who do not have chronic pain or skin conditions that could affect device use. 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, if you are a chronic opioid user or have active drug abuse, you would not be eligible to participate.
What prior data suggests that the NeuroCuple device is safe for managing postoperative pain in females undergoing cesarean delivery?
Research shows that the NeuroCuple™ device could safely manage post-surgical pain. Studies suggest it might reduce the need for opioid pain medications, decreasing the risk of opioid-related side effects. Previous data indicates that patients generally tolerate the device well, with no major side effects reported. The NeuroCuple device operates without drugs, relying on non-medication methods for effectiveness. Thus far, it appears to be a promising option for managing pain without the usual medication risks.12345
Why are researchers excited about this trial?
Researchers are excited about the NeuroCuple Device because it offers a non-invasive approach to managing pain, specifically designed for post-partum recovery. Unlike standard treatments that often rely on medications like NSAIDs or opioids, which can have side effects and pose risks for new mothers, the NeuroCuple Device uses a novel mechanism to potentially alleviate pain without drugs. This device works by being placed in the PACU (Post Anesthesia Care Unit), possibly providing immediate relief as mothers transition to the post-partum unit. Its drug-free nature and the potential for immediate effect make it a promising alternative to traditional pain management methods.
What evidence suggests that the NeuroCuple device is effective for managing postoperative pain after cesarean delivery?
Research has shown that the NeuroCuple device, which participants in this trial may receive, could help manage pain after surgery. One study reduced the number of patients needing opioids by 9%. Another study found it decreased the need for opioid refills by 47% in the first month after surgery. Patients using the device also reported feeling 34% less pain while resting. These results suggest that the NeuroCuple device might help lessen pain and reduce the need for opioids after a cesarean delivery.12678
Who Is on the Research Team?
Antonio Saad, MD
Principal Investigator
Inova Health Care Services
Are You a Good Fit for This Trial?
This trial is for women undergoing cesarean delivery who may benefit from a new non-pharmacological analgesic device called NeuroCuple™. The study aims to see if this device can reduce pain and the need for opioid medication after surgery.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either the NeuroCuple device, a sham device, or standard care for postoperative pain management
Follow-up
Participants are monitored for pain scores, opioid intake, and quality of recovery
What Are the Treatments Tested in This Trial?
Interventions
- NeuroCuple Device
- Sham
Find a Clinic Near You
Who Is Running the Clinical Trial?
Inova Health Care Services
Lead Sponsor
nCap Medical
Industry Sponsor