BridgeMD
New treatment option for Pain
Official title Impact of the NeuroCuple Device on Pain Management After Cesarean Delivery
ClinicalTrials.gov ID: NCT07185425
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Female 18 years or older able to provide informed consent in English or Spanish
- Scheduled for a planned or unplanned non-emergent cesarean delivery under neuraxial anesthesia
- Intact skin surfaces around the operative skin incision area at the site of patch application
- Pfannestiel skin incision
You likely can't join if
- Active drug abuse
- Chronic opioid user
- Severe chronic pain
- Psoriasis vulgaris or other skin conditions precluding safe device application
- Subject is concurrently participating in another research study with an investigational drug or medical device that in the Investigator's opinion...
- Subject with reasons to maintain an epidural beyond operative room
See the full eligibility criteria
- Female 18 years or older able to provide informed consent in English or Spanish
- Scheduled for a planned or unplanned non-emergent cesarean delivery under neuraxial anesthesia
- Intact skin surfaces around the operative skin incision area at the site of patch application
- Pfannestiel skin incision
- Active drug abuse
- Chronic opioid user
- Severe chronic pain
- Psoriasis vulgaris or other skin conditions precluding safe device application
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Falls Church, Virginia, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Falls Church, Virginia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.