Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06434714
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-30
First Post:
2024-05-23
Brief Title:
Management of Postoperative Pain After Cesarean Delivery Using Bridge Auricular Percutaneous Nerve Field Stimulator
Sponsor:
Inova Fairfax Hospital
Organization:
Inova Fairfax Hospital
Study Overview
Official Title:
Management of Postoperative Pain After Cesarean Delivery Using Bridge Auricular Percutaneous Nerve Field Stimulator
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Post-cesarean section CS pain is commonly treated with acetaminophen ibuprofen and opioid medications as needed following delivery About 300000 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
Detailed Description:
Cesarean delivery is one of the most performed surgeries in the US with approximately 115 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 33 oxycodone 5-mg tablets to 1950 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 US women who are prescribed opioids after a cesarean delivery receive at least 10 more tablets than necessary A study looking at individualizing opioid prescriptions based on inpatient requirements found that women used about 60 of their prescription regardless of the amount of opioids prescribed Decreasing opioid requirement after cesarean delivery can decrease womens exposure to opioids reduce the risk of neonatal central nervous system depression due to exposure in breastmilk and limit the potential for extra opioids from unused filled prescriptions to fall into the wrong hands Post-cesarean mothers use opioids for a median of 8 days after delivery Bridge is a minimally invasive device shown in previous studies to reduce pain medication requirements in the post-operative acute recovery period The device is a auricular percutaneous electrical nerve stimulator that modulates pain receptors leading to reduced pain sensation This trial study to examine the utility of the Bridge device as an adjunct to standard of care post-cesarean pain regimens acetaminophen ibuprofen or ketorolac and oxycodone or other similar opioid Post-cesarean patients will be randomized in a 111 ratio to Bridge device sham device or standard of care treatment and followed through the postpartum period
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None