Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06460350
Status:
RECRUITING
Last Update Posted:
2024-06-14
First Post:
2024-06-11
Brief Title:
NEUROCUPLE in TKA Patients to Enhance Pain Management
Sponsor:
nCap Medical
Organization:
nCap Medical
Study Overview
Official Title:
Enhancing Pain Management for Knee Replacement Patients Through an Innovative Non-invasive and Opioid-sparing Device NEUROCUPLE
Status:
RECRUITING
Status Verified Date:
2024-10
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:
This is a randomized 11 placebo-controlled clinical trial to determine the feasibility and effectiveness of 30-day application of NEUROCUPLE patch for pain reduction and opioid consumption following TKA Results will establish NEUROCUPLE as an effective non-opioid postoperative pain management device for FDA approval Importantly we have a placebo device device without the captor array layer that looks exactly like the active device allowing us to conduct a true placebo randomized study
Detailed Description:
Total knee arthroplasty TKA is the most common elective surgical procedure By 2030 35 million TKA procedures are expected1 to be performed Multiple factors can contribute to an individuals need for TKA however the primary factor is osteoarthritis15 and pain Osteoarthritis affects approximately 325 million individuals in the US leading to an enormous economic burden ranging from 15-16 billion dollars annually Although most diagnosed with osteoarthritis should undergo TKA the fear of experiencing severe long lasting postoperative pain causes many to postpone the surgery For those that do elect surgery postoperative pain decreases quality of life and an increase in risk of chronic opioid use Out of 98623 individuals who received TKA from 2015 to 2019 it was reported that 72 received opioid prescriptions in duration and dosage which was proposed to be the cause of long-term opioid use
Postoperative pain strategies for TKA often requires opioid use To mitigate postoperative pain management following TKA a multimodal approach is often used as a part of enhanced recovery after surgery ERAS protocols This approach on the use of on peripheral nerve blocks PNBs acetaminophen non-steroidal anti-inflammatory drugs NSAIDs and opioids131819 Postoperative opioid and NSAIDS can lead to excessive sedation vomiting nausea hypotension major bleeding life-threatening respiratory depression constipation renal failure frequent delayed functional recovery increase cost of care and prolong hospital stay Furthermore the postoperative prescription of use opioids leads to long-term opioid users in 347 to 535 Patients with poorly controlled acute surgical pain are at risk for chronic post-surgical pain opioid dependence and long-term opioid use Thus there is an urgent and unmet clinical need for a reliable technology to predict and reduce opioid use and costly opioid adverse effects while enhancing surgical pain relief On an economic point of view evidence also demonstrates that persistent postoperative pain leads to a loss in work productivity and absenteeism mounting to an average loss of 13761 per individual Therefore there is a significant need for alternative non-pharmacological and non-opioid therapies that are effective in treating postoperative pain management in patients undergoing TKA
Clinical approaches associated with postoperative pain and opioids in TKA Data compiled from 90 million patients from 38 hospital networks and 18 non-network hospitals demonstrated that reliance on opioids for postoperative pain management is still extremely high 915 following a TKA Evidence supporting the use of PNBs is lacking and their use may increase the risk of fall Sharma et al 2010 reported that femoral nerve blocks conducted in 709 patients lead to postoperative falls n13 patients A study including 250 patients demonstrated that postoperative falls led to an extended hospital stay Furthermore nerve injury and major bleeding have also been reported following PNBs Complementary techniques such as Transcutaneous Electrical Nerve Stimulation TENS acupuncture and hypnosis have been proposed but evidence supporting the use of these techniques is still limited and the use of these techniques requires expertise and time Therefore current postoperative pain treatments remain unsatisfactory
A pain relief patch that provides a clinically effective alternative to opioid use for pain management The scientific premise of our proposal rests upon the published literature and our preliminary data that demonstrates the use of pain relief patches for pain management Pain and local inflammation following tissue injuries is the result of the release of a number of mediators and ions decreases in pH increase in acidity and changes in local electrical potential This is in part due to the central nervous system stimulation of nociceptors and the anterior and lateral spinothalamic tracts The NEUROCUPLE devices millions of nanocapacitors capture and release the excess electrical load generated by trauma thus blocking the transmission of the local pain signals
An observational study evaluating non-surgical patients n66 using our licensed nanotechnology topical analgesic demonstrated a 71 reduction in Brief Pain Inventory pain severity Fig 1 improvements in quality of life and a 98 reduction in oral pain medication use Our additional preliminary data in patients undergoing a TKA demonstrated that the use of the patch device plus standard on care was associated with a 36 reduction in pain at rest by postoperative day 3 and more importantly a reduction of 47 in the number of patients requesting an opioid refill beyond their initial prescription within the first 30 days compared to the patients receiving only standard of care Thus we believe our clinical data provides a strong scientific premise for utilizing pain relief patches as an alternative to analgesic drugs to provide effective and safe postoperative approach to reduce postoperative analgesia and more importantly to greatly reduce the number of patients requiring long term opioid exposure which has been demonstrated as a risk for postoperative opioid use disorder OUD in surgical patients
Postoperative pain strategies for TKA often requires opioid use To mitigate postoperative pain management following TKA a multimodal approach is often used as a part of enhanced recovery after surgery ERAS protocols This approach on the use of on peripheral nerve blocks PNBs acetaminophen non-steroidal anti-inflammatory drugs NSAIDs and opioids131819 Postoperative opioid and NSAIDS can lead to excessive sedation vomiting nausea hypotension major bleeding life-threatening respiratory depression constipation renal failure frequent delayed functional recovery increase cost of care and prolong hospital stay Furthermore the postoperative prescription of use opioids leads to long-term opioid users in 347 to 535 Patients with poorly controlled acute surgical pain are at risk for chronic post-surgical pain opioid dependence and long-term opioid use Thus there is an urgent and unmet clinical need for a reliable technology to predict and reduce opioid use and costly opioid adverse effects while enhancing surgical pain relief On an economic point of view evidence also demonstrates that persistent postoperative pain leads to a loss in work productivity and absenteeism mounting to an average loss of 13761 per individual Therefore there is a significant need for alternative non-pharmacological and non-opioid therapies that are effective in treating postoperative pain management in patients undergoing TKA
Clinical approaches associated with postoperative pain and opioids in TKA Data compiled from 90 million patients from 38 hospital networks and 18 non-network hospitals demonstrated that reliance on opioids for postoperative pain management is still extremely high 915 following a TKA Evidence supporting the use of PNBs is lacking and their use may increase the risk of fall Sharma et al 2010 reported that femoral nerve blocks conducted in 709 patients lead to postoperative falls n13 patients A study including 250 patients demonstrated that postoperative falls led to an extended hospital stay Furthermore nerve injury and major bleeding have also been reported following PNBs Complementary techniques such as Transcutaneous Electrical Nerve Stimulation TENS acupuncture and hypnosis have been proposed but evidence supporting the use of these techniques is still limited and the use of these techniques requires expertise and time Therefore current postoperative pain treatments remain unsatisfactory
A pain relief patch that provides a clinically effective alternative to opioid use for pain management The scientific premise of our proposal rests upon the published literature and our preliminary data that demonstrates the use of pain relief patches for pain management Pain and local inflammation following tissue injuries is the result of the release of a number of mediators and ions decreases in pH increase in acidity and changes in local electrical potential This is in part due to the central nervous system stimulation of nociceptors and the anterior and lateral spinothalamic tracts The NEUROCUPLE devices millions of nanocapacitors capture and release the excess electrical load generated by trauma thus blocking the transmission of the local pain signals
An observational study evaluating non-surgical patients n66 using our licensed nanotechnology topical analgesic demonstrated a 71 reduction in Brief Pain Inventory pain severity Fig 1 improvements in quality of life and a 98 reduction in oral pain medication use Our additional preliminary data in patients undergoing a TKA demonstrated that the use of the patch device plus standard on care was associated with a 36 reduction in pain at rest by postoperative day 3 and more importantly a reduction of 47 in the number of patients requesting an opioid refill beyond their initial prescription within the first 30 days compared to the patients receiving only standard of care Thus we believe our clinical data provides a strong scientific premise for utilizing pain relief patches as an alternative to analgesic drugs to provide effective and safe postoperative approach to reduce postoperative analgesia and more importantly to greatly reduce the number of patients requiring long term opioid exposure which has been demonstrated as a risk for postoperative opioid use disorder OUD in surgical patients
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?:
False
Is an FDA AA801 Violation?:
None