A Pilot Study Investigating the nCAP Signal Relief Patch in Subjects Undergoing Primary Hip or Knee Replacement Surgery

Study Overview
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Brief Summary
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Opioid addiction in post-operative patients is recognized but not fully understood; therefore, in order to address this growing crisis, it is essential to explore alternative approaches to managing pain and apply them to the surgical population. One potential non-opioid method of pain relief is the use of the nCAP Nano Patch, placed topically on the site of pain. The objective of this study is to investigate the efficacy of the nCAP Signal Relief Patch in reducing the perioperative opioid requirement in patients undergoing primary unilateral total hip or knee replacement surgery.

Detailed Description
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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, in the pre-operative holding area 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). These assessments will take approximately 15 minutes to complete. 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. 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 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. 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.

Official Title
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A Pilot Study Investigating the nCAP Signal Relief Patch in Subjects Undergoing Primary Hip or Knee Replacement Surgery: A Prospective, Randomized, Open Label Trial

Conditions
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Opioid Use, Pain, Post Operative

Intervention / Treatment
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* Device: nCAP Signal Relief Patch
* Other: Standard of Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: >18 years of age Scheduled for elective primary unilateral hip or knee replacement Exclusion Criteria: Active clinical depression, anxiety or catastrophizing Raw score >19 on PROMIS Emotional Distress - Anxiety - Short Form 8a Active alcoholism (defined as daily use of more than 1 liter of wine and/or 3 or more shots of hard liquor) or drug abuse (defined as daily use of illicit drugs) Severe chronic pain condition that requires daily preoperative opioid dependence Total surgery revision, bilateral hip or nee replacement, other procedures under the same anesthetic

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Single-center prospective, randomized, open label trial involving patients undergoing unilateral hip replacement and patients undergoing unilateral knee replacement that score <19 on the PROMIS Emotional Distress - Anxiety - Short Form 8a
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: nCAP + ERAS<br>Participants will have the nCAP Signal Relief Patch and complete Enhanced Recovery After Surgery (ERAS) standard of care. 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). | Device: nCAP Signal Relief Patch<br>* nCAP Signal Relief Patch post-operatively applied to the subject's surgical dressing by a trained researcher in the immediate Post Anesthesia Care Unit (PACU)<br>* Other names: treatment patch;Other: Standard of Care<br>* Subjects will undergo surgery using the approved ERAS anesthetic and post-operative pain management protocols. At Shadyside Hospital, the ERAS Protocol for these subjects involves preoperative meloxicam 15mg PO, gabapentin 300mg PO, acetaminophen 1g PO. Intra-operative, patients receive a spinal block (bupivacaine) and propofol IV sedation. Postoperative pain medication is titrated to the individual patient's level of pain (0-10). 0.2 mg IV hydromorphone can be given for breakthrough pain, oxycodone 5mg PO for moderate pain (4-6) and oxycodone 10 mg PO for severe pain (7-10). Ketorolac 15 mg IV is given Q6H during the hospital stay. Discharge medication may be Norco 5-325mg as prescribed by the surgeon.<br>* Other names: Enhanced Recovery After Surgery (ERAS);|
| Active Comparator: ERAS alone<br>Participants randomized into the control group will receive complete Enhanced Recovery After Surgery (ERAS) standard of care and no nCAP patch. | Other: Standard of Care<br>* Subjects will undergo surgery using the approved ERAS anesthetic and post-operative pain management protocols. At Shadyside Hospital, the ERAS Protocol for these subjects involves preoperative meloxicam 15mg PO, gabapentin 300mg PO, acetaminophen 1g PO. Intra-operative, patients receive a spinal block (bupivacaine) and propofol IV sedation. Postoperative pain medication is titrated to the individual patient's level of pain (0-10). 0.2 mg IV hydromorphone can be given for breakthrough pain, oxycodone 5mg PO for moderate pain (4-6) and oxycodone 10 mg PO for severe pain (7-10). Ketorolac 15 mg IV is given Q6H during the hospital stay. Discharge medication may be Norco 5-325mg as prescribed by the surgeon.<br>* Other names: Enhanced Recovery After Surgery (ERAS);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of the nCAP Signal Relief Patch in affecting perioperative opioid requirement | The primary endpoint will be to prospectively investigate the efficacy of the nCAP Signal Relief Patch in reducing perioperative opioid requirement in opioid-naïve patients undergoing primary unilateral total hip or knee replacement surgery using currently SHY ERAS anesthesia protocol. This is reported in consumption of oral morphine mg equivalents (OME) at day 1, 2, 3, 7, 14, and 30 post-operative. Opioid requirement will be estimated following the placement of the patch. | Day of surgery up to 30 days post-operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pre-operative emotional distress related to anxiety | Pre-operative emotional distress related to anxiety will be measured by assessment of participant's answers to the PROMIS Emotional Distress -Anxiety- Short Form 8a questionnaire prior to surgery. There are 8 questions about how the participants may have felt in the past 7 days. The scale for each question is from 1, never felt this way in the past 7 days, to 5, always have felt this way in the past 7 days. The overall questionnaire scores can range from 8 (least severe score) to 40 (most severe score). Higher scores present a worse outcome. | Screening visit | 
| Post-operative change in emotional distress related to anxiety | Post-operative emotional distress related to anxiety will be measured by assessment of participant's answers to the PROMIS Emotional Distress -Anxiety- Short Form 8a questionnaire.There are 8 questions about how the participants may have felt in the past 7 days. The scale for each question is from 1, never felt this way in the past 7 days, to 5, always have felt this way in the past 7 days. The overall questionnaire scores can range from 8 (least severe score) to 40 (most severe score). Higher scores present a worse outcome. | Day 1, 2, 3, 7, 14, and 30 post-operative | 
| Pre-operative emotional distress related to depression | Pre-operative emotional distress related to depression will be measured by assessment of participant's answers to the PROMIS Emotional Distress-Depression-Short Form questionnaire prior to surgery. There are 8 questions about how the participant may have felt in the past 7 days. The scale for each question is from 1, never felt this way in the past 7 days, to 5, always have felt this way in the past 7 days. The overall questionnaire scores can range from 8 (least severe score) to 40 (most severe score). Higher scores present a worse outcome. | Screening visit | 
| Post-operative change in emotional distress related to depression | Post-operative emotional distress related to depression will be measured by assessment of participant's answers to the PROMIS Emotional Distress-Depression-Short Form questionnaire. There are 8 questions about how the participant may have felt in the past 7 days. The scale for each question is from 1, never felt this way in the past 7 days, to 5, always have felt this way in the past 7 days. The overall questionnaire scores can range from 8 (least severe score) to 40 (most severe score). Higher scores present a worse outcome. | Day 1, 2, 3, 7, 14, and 30 post-operative | 
| Pre-operative sleep disturbance | Pre-operative sleep disturbance will be measured by assessment of the participant's answers to the PROMIS item Bank v1.0 - Sleep Disturbance - Short Form 8a. There are 8 questions about how the participant may have felt about their sleep quality in the past 7 days. The scale for 1 question is very poor in the past 7 days to very good in the past 7 days. The scale for 7 questions is not at all in the past 7 days to very much in the past 7 days. | Screening visit | 
| Post-operative change in sleep disturbance | Post-operative sleep disturbance will be measured by assessment of the participant's answers to the PROMIS item Bank v1.0 - Sleep Disturbance - Short Form 8a. There are 8 questions about how the participant may have felt about their sleep quality in the past 7 days. The scale for 1 question is very poor in the past 7 days to very good in the past 7 days. The scale for 7 questions is not at all in the past 7 days to very much in the past 7 days. | Day 1, 2, 3, 7, 14, and 30 post-operative | 
| Number of participants who passed pre-operative functionality test | Pre-operative functionality will be measured by assessment of the participant's answers to a baseline functionality test, assessing mobility and strength in their leg. This test will include the patient's ability to walk 100 feet, go up 5 steps and raise their leg. Outcome of functionality is either pass or fail. | Screening visit | 
| Number of participants who passed post-operative functionality test | Post-operative functionality will be measured by assessment of the participant's answers to a baseline functionality test, assessing mobility and strength in their leg. This test will include the patient's ability to walk 100 feet, go up 5 steps and raise their leg. Outcome of functionality is either pass or fail. | Day 1, 2, 3, 7, 14, and 30 post-operative | 
| Pre-operative pain rating using the Pain Catastrophizing Scale | Pre-operative pain ratings will be measured by the assessment of the participant's answers to the Pain Catastrophizing Scale questionnaire. There are 14 statements related to pain that participants will record experiencing on a scale of 0 being experienced not at all to 4 being experienced all of the time. The lowest possible score is 0 and the highest possible score is 56. Higher scores present a worse outcome | Screening visit | 
| Change in post-operative pain rating using the Pain Catastrophizing Scale | Post-operative pain ratings will be measured by the assessment of the participant's answers to the Pain Catastrophizing Scale questionnaire. There are 14 statements related to pain that participants will record experiencing on a scale of 0 being experienced not at all to 4 being experienced all of the time. The lowest possible score is 0 and the highest possible score is 56. Higher scores present a worse outcome | Day 1, 2, 3, 7, 14, and 30 post-operative | 
| Length of hospital stay | Evaluate time to hospital discharge from out of OR time. | Day of surgery up to 30 days post-operative | 
| Number of participants who experienced post-operative complications related to opioid use | The number of participants who experienced complications related to opioid use and received the nCAP patch + standard of care versus subjects who received the standard of care. Complications can be defined as problems that arise following opioid use including post-operative nausea and vomiting, itching, sleep disorders, respiratory depression and urinary retention. | Day of surgery up to day 30 post-operative | 
| Change in post-operative pain using a numerical rating scale | Numerical Rating Scale (NRS) Pain scores on a scale from 0-10, with 0 being no pain, 5 being moderate pain and 10 being the worst imaginable pain. The lowest possible score is 0 and the highest possible score is 10. higher scores represent a worse outcome. | Day 1, 2, 3, 7, 14, and 30 post-operative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Joint replacement surgery, Post operative pain management, Neuro capacitor