A Pilot Study Investigating the nCAP Signal Relief Patch in Subjects Undergoing Primary Hip or Knee Replacement Surgery: A Prospective, Randomized, Open Label Trial
Phase: NA
Conditions: Opioid Use, Pain, Post Operative
Sponsor: Jacques E. Chelly

nCAP Signal Relief Patch Pilot 
 
Jacques E. Chelly, MD, PhD, MBA 
 
 
 
 
 
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Project Title: A Pilot Study Investigating the nCAP Signal Relief Patch in Subjects 
Undergoing Primary Hip or Knee Replacement Surgery: A Prospective, Randomized, 
Open Label Trial 
IRB: STUDY22010018 
NCT: 05252858 
Date of Approval: 08/10/2022 
 

nCAP Signal Relief Patch Pilot 
 
Jacques E. Chelly, MD, PhD, MBA 
 
 
 
 
 
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Statement of Problem 
The current opioid epidemic has led to a renewed interest in exploring non-
pharmacological techniques to treat post-operative pain. Opioids are also not the drug of choice 
for the treatment of perioperative pain because their administration is associated with adverse 
effects, including post-operative nausea and vomiting, respiratory depression, 
immunosuppression, constipation, and opioid use disorder and the risk of opioid overdose and 
death. In the United States, over $600 billion is spent every year on opioid addiction, including 
$79 billion related to opioid addiction following surgery. Despite many initiatives to decrease the 
use of opiates in the preoperative setting, opioids continue to be regularly prescribed before, 
during, and after surgery. Although the risk of opioid addiction following surgery is recognized, 
the percentage of patients becoming addicted to opioids following surgery is not well 
understood. Although guidelines have been published regarding the use of opioids, it is 
established that opioids are still overused. Therefore, in order to combat this growing health 
crisis at the ground level, it is incumbent upon the medical community to explore alternative 
methods to the use of opioids and apply these approaches to surgical population. This is 
especially important in the context of COVID-19 because it is clear that we have been 
experiencing an increase in death related to opioid overdose. 
Evidence supports the concept that the human body is “electric.” This property is 
routinely used to monitor organ function such as the heart, the brain, and more. In the case of 
local trauma and pain, it is established that pain is the result of local inflammation, a local 
decrease in pH and therefore an accumulation of negative charges. In this respect the nCAP 
Nano patch is a patch charged negatively. Therefore, when applied at the site of the pain, the 

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patch redistributes the negative charges at the local level and this redistribution away from the 
local site has an anti-inflammatory and an analgesic effect.    
Specific Aims 
1. The primary endpoint will be to prospectively investigate the efficacy of the nCAP Signal 
Relief Patch in reducing perioperative opioid requirement (up to 72 hours post-op) in 
opioid-naïve patients undergoing primary unilateral total hip or knee replacement 
surgery. Opioid requirement will be estimated following the placement of the patch. 
2. The secondary endpoint will include the effects of nCAP Signal Relief Patch after the 
placement on postoperative pain, functional recovery, time to discharge from the hospital, 
and opioid related complications, such as, PONV, itching, sleep disorders, respiratory 
depression, and urinary retention.  
Study Design 
The proposed pilot study will be conducted as a single-center prospective, randomized, 
open label trial at the University of Pittsburgh Medical Center (UPMC) Shadyside Hospital. 
Institutional review board approval will be obtained before eligible patients are recruited and 
consented. The trial will be registered at www.clinicaltrial.gov before beginning recruitment.  
The efficacy of this device will be established by comparing postoperative opioid 
requirement to maintain pain scores ≤ 4 using a Numerical Rating Scale (NRS). Accordingly, 
pain will be treated according to the following protocol: pain scores ≤ 4, non-opioid analgesics, 
pain scores between 4 and 6 oxycodone 5 mg q 4 hrs and ≥ 7, oxycodone 10 mg, 
Hydromorphone IV 0.2-0.5 mg q 3 hr. Data collected following the placement in the treatment 
group (Standard of Care ERAS protocol + nCAP Signal Relief Patch) will be compared to the 
data obtained in the control group (Standard of Care ERAS protocol). 

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Recruitment 
Potential subjects may be given a recruitment flyer (attached) in the office of surgeons Drs. 
O'Malley, Plate, or Klatt. The potential subjects who receive a flyer will then have the option of 
contacting the study team to discuss the study further, or, if they express interest in participating 
in the surgeon's office, their name will be given to the study team from the surgeon's office staff. 
 
Potential subjects may also be identified by the study team who has normal access to the 
Operating Room Schedule and electronic medical records. If a subject is deemed eligible via 
inclusion/exclusion criteria, a study team member will approach them the morning of their 
scheduled surgery and discuss the study with them at length and answer any questions they may 
have. If a potential subject is willing to sign consent, then a physician investigator will be 
available to review the consent, risks and benefits of participation, and obtain informed consent. 
 
If our research team is contacted prior to the day of surgery, or if we reach out based upon the 
list of interested potential subjects, study team will discuss the study at length over the phone and 
answer any questions the potential subjects may have. Subjects interested in participating will be 
emailed the currently approved informed consent form to review. They will be given the option 
to sign consent electronically for convenience via REDCap or they can sign consent form on the 
day of surgery in the pre-operative holding area. 
 
The subject will be approached as soon as they arrive to the hospital (at least 2-3 hours before 
their surgery) and will be given adequate time to consider the consent and ask questions. The 
patient will be urged to take as long as necessary to decide whether or not to participate. If the 

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subject feels they do not have enough time to make a decision, they will not be enrolled in the 
trial.  
 
All questions will be addressed and it will be made clear that the patient may withdraw 
from the study at any time. Investigator physician will sign the informed consent with the patient 
prior to beginning of any study procedures. 
Randomization Process 
Participating patients will be randomized by computer-generated random numbers to 
either the control group (standard of care ERAS protocol) or intervention group (nCAP Signal 
Relief Patch group+ ERAS protocol). 
Inclusion Criteria: 
• Over 18 years of age 
• Scheduled for elective primary unilateral hip or knee replacement surgery 
Exclusion Criteria: 
• Active clinical depression, anxiety, or catastrophizing 
• Raw score equal to or greater than 19 on the PROMIS Anxiety 8a - Adult v1.0 
• Active alcoholism or drug abuse  
• Severe chronic pain condition that requires daily preoperative opioid dependence 
• Total surgery revision, bilateral hip replacement, multiple surgeries 
Treatment Groups 
Each subject will undergo surgery and anesthesia using the approved ERAS protocol. 
Control Arm (n=30): Control group will receive approved ERAS multimodal anesthesia 
protocol (standard of care). 

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Interventional Arm (n=30): Intervention group will receive approved ERAS 
multimodal anesthesia protocol plus an nCAP Signal Relief Patch. 
Data Collection and Outcome Measures 
After signing an informed consent, subjects will complete the PROMIS Emotional 
Distress – Anxiety – Short Form 8a before completing any other questionnaires. Subjects who 
have a raw score <19 will be enrolled in the study. Any subject who scores ≥ 19 will be 
considered a screen failure and excluded from the study.  
Once the subject is enrolled, they will be asked to complete the Pain Catastrophizing 
Scale (PCS), the PROMIS® Emotional Distress-Depression - Short Form 8a, and the PROMIS® 
Item Bank v1.0 – Sleep- Disturbance – Short Form 8a prior to surgery. The subject will also 
conduct a baseline functionality test to assess mobility and strength in their leg. The functional 
recovery will be assessed by determining the patient ability to walk 100 feet, go up 5 steps and 
raise their leg on the day of surgery. Scores can be 0 (no ability to raise the leg), 1 (some ability 
to raise the leg), and 2 (complete ability to raise the leg).  
Once these assessments are completed, subjects will be equally randomized to the 
intervention group (nCAP signal relief Patch + standard of care) or control group (standard of 
care). Both the control group and intervention group will receive approved ERAS multimodal 
standard of care. Only the interventional group will receive an nCAP Signal Relief Patch. 
Randomization will occur by assigning the participant a subject ID number, and this ID number 
will correspond to a treatment allocation based on a pre-designed randomization schema. 
Subjects will undergo surgery using the approved ERAS anesthetic and post-operative 
pain management protocols.  

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After surgery, the subjects randomized to the intervention group will have the nCAP 
Signal Relief patch applied to their surgical dressing by a trained researcher in the immediate 
Post Anesthesia Care Unit (PACU). Subjects will be made aware at the time of consent and 
throughout the trial that they can drop out of the study at any time if they do not like wearing the 
nCAP Signal Relief Patch. The control group will not receive a patch but will receive the 
standard of care ERAS protocol.  Subjects in the intervention group will be instructed to keep the 
nCAP Signal Relief Patch on their surgical dressing to avoid the risk for skin irritation. 
Pain using a Numerical Rating Scale (NRS) at rest and with movement as well as opioid 
requirement will be assessed in the PACU and daily until discharge.  
Subjects assigned to the intervention group should keep the nCAP Signal Relief Patch in 
place for 72 hours on their surgical dressing and they will be instructed to remove it at home. 
Once the subject is discharged, they will be asked to complete a pain and opioid diary to 
record pain-related outcomes. They will be contacted via email (REDCAP survey) on post-
operative day 1,2,3, 7, 14, and 30 to record postoperative opioid consumption, non-opioid 
consumption, NRS pain at rest and with movement, pain catastrophizing (via Pain 
Catastrophizing Scale) sleep quality (via PROMIS Sleep Disturbance Short Form 8a) and to 
assess functional recovery. Functional recovery will be assessed by determining the patient 
ability to walk 100 feet, go up 5 steps and raise their leg on postoperative days 1, 2, 3, 7, 14, and 
30 as well as the pain associated with it. Patient satisfaction with pain management after surgery 
will be assessed at the 30 day follow up (0- least satisfied to 10-most satisfied).  Subjects who 
are contacted via REDCap to complete follow-up questionnaires and do not complete them on 
the day they are assigned will be contacted via telephone for a reminder. They will be considered 
lost to follow up after 3 phone attempts. 

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Information will be collected from the medical record, including: patient demographics, 
medical history, medication summary while in the hospital, as well as progress notes from the 
entire encounter to determine the existence of adverse events. 
Pre-and-Post Metric Evaluation 
The use of a non-pharmacological nCAP Signal Relief Patch has the possibility of 
providing analgesia to post-surgical patients and reducing the number of opioids required 
following surgery. This will significantly impact patient outcomes, as patients will experience 
fewer opioid-related side effects (such as respiratory depression, post-operative nausea and 
vomiting, constipation, and delirium). This will also impact clinicians caring for post-operative 
patients, as there is the real potential they will have fewer conditions to monitor and treat as the 
patient recovers from surgery. The projected number of patients served by this project will 
initially be 70 enrolled participants at Shadyside Hospital, however, the data collected from this 
trial will serve countless patients and the community at large as physicians strive to move away 
from opioid use following surgery. Data collected from this pilot study will support a future 
proposal to the National Institute of Drug Abuse (NIDA) to fund a full-scale, randomized, 
placebo-controlled trial using the nCAP Signal Relief Patch. 
Perhaps most importantly, the investigative use of the non-invasive nCAP Signal Relief 
patch has the ability to significantly decrease opioid requirement, postoperative pain, the hospital 
length of stay, the needs for opioid prescription following discharge from the hospital, improve 
early functional recovery, and increase patient satisfaction. 
Being able to offer the orthopedic patients at UPMC Shadyside Hospital such an 
alternative might represent a non-pharmacological approach to pain management and an 
alternative to opioid, increase patient satisfaction, and improve early functional recovery.