Trial Outcomes & Findings for A Pilot Study Investigating the nCAP Signal Relief Patch in Subjects Undergoing Primary Hip or Knee Replacement Surgery (NCT NCT05252858)

Last Updated: 2024-04-18

Results Overview

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) from the day of surgery up to day 30 post-operative. Opioid requirement will be estimated following the placement of the patch.

Recruitment status

COMPLETED

Study phase

Target enrollment

79 participants

Primary outcome timeframe

Day of surgery up to 30 days post-operative

Results posted on

2024-04-18

Participant Flow

Participant milestones

Participant milestones
Measure	nCAP + ERAS 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). nCAP Signal Relief Patch: 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) Standard of Care: 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.	ERAS Alone Participants randomized into the control group will receive complete Enhanced Recovery After Surgery (ERAS) standard of care and no nCAP patch. Standard of Care: 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.
Overall Study STARTED	38	31
Overall Study COMPLETED	38	31
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	nCAP + ERAS n=38 Participants 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). nCAP Signal Relief Patch: 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) Standard of Care: 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.	ERAS Alone n=31 Participants Participants randomized into the control group will receive complete Enhanced Recovery After Surgery (ERAS) standard of care and no nCAP patch. Standard of Care: 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.	Total n=69 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=5 Participants	9 Participants n=7 Participants	20 Participants n=5 Participants
Age, Categorical >=65 years	27 Participants n=5 Participants	22 Participants n=7 Participants	49 Participants n=5 Participants
Age, Continuous	68 years STANDARD_DEVIATION 8.9 • n=5 Participants	69.6 years STANDARD_DEVIATION 9.0 • n=7 Participants	68.7 years STANDARD_DEVIATION 8.9 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	12 Participants n=7 Participants	30 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	19 Participants n=7 Participants	39 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	37 Participants n=5 Participants	31 Participants n=7 Participants	68 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) White	35 Participants n=5 Participants	25 Participants n=7 Participants	60 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	38 participants n=5 Participants	31 participants n=7 Participants	69 participants n=5 Participants
Weight	89.9 kg STANDARD_DEVIATION 10.6 • n=5 Participants	89.1 kg STANDARD_DEVIATION 17.8 • n=7 Participants	89.6 kg STANDARD_DEVIATION 14.2 • n=5 Participants
Height	170.0 cm STANDARD_DEVIATION 11.4 • n=5 Participants	169.0 cm STANDARD_DEVIATION 11.5 • n=7 Participants	169.5 cm STANDARD_DEVIATION 11.3 • n=5 Participants
BMI	31.4 Kg/m^2 STANDARD_DEVIATION 4.8 • n=5 Participants	30.9 Kg/m^2 STANDARD_DEVIATION 4.7 • n=7 Participants	31.2 Kg/m^2 STANDARD_DEVIATION 4.7 • n=5 Participants
Surgery Type Total Knee Arthroplasty	31 Participants n=5 Participants	29 Participants n=7 Participants	60 Participants n=5 Participants
Surgery Type Total Hip Arthroplasty	7 Participants n=5 Participants	2 Participants n=7 Participants	9 Participants n=5 Participants
PROMIS - Anxiety questionnaire	48 T-score STANDARD_DEVIATION 6.0 • n=5 Participants	44.1 T-score STANDARD_DEVIATION 7.5 • n=7 Participants	46.2 T-score STANDARD_DEVIATION 7.0 • n=5 Participants
PROMIS - Emotional Distress - Depression questionnaire	41.9 T-score STANDARD_DEVIATION 7.1 • n=5 Participants	40.4 T-score STANDARD_DEVIATION 4.7 • n=7 Participants	41.3 T-score STANDARD_DEVIATION 6.2 • n=5 Participants
PROMIS - Sleep Disturbance questionnaire	51.4 T-score STANDARD_DEVIATION 7.0 • n=5 Participants	47.4 T-score STANDARD_DEVIATION 9.3 • n=7 Participants	49.6 T-score STANDARD_DEVIATION 8.3 • n=5 Participants
Pain Catastrophizing scale	5.8 units on a scale STANDARD_DEVIATION 6.1 • n=5 Participants	6.8 units on a scale STANDARD_DEVIATION 8.4 • n=7 Participants	6.3 units on a scale STANDARD_DEVIATION 7.2 • n=5 Participants
Functional Recovery Test	3.7 units on a scale STANDARD_DEVIATION 0.6 • n=5 Participants	3.5 units on a scale STANDARD_DEVIATION 1.0 • n=7 Participants	3.6 units on a scale STANDARD_DEVIATION 0.8 • n=5 Participants

PRIMARY outcome

Timeframe: Day of surgery up to 30 days post-operative

Outcome measures

Outcome measures
Measure	nCAP + ERAS n=38 Participants 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). nCAP Signal Relief Patch: 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) Standard of Care: 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.	ERAS Alone n=31 Participants Participants randomized into the control group will receive complete Enhanced Recovery After Surgery (ERAS) standard of care and no nCAP patch. Standard of Care: 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.
Efficacy of the nCAP Signal Relief Patch in Affecting Perioperative Opioid Requirement	82.1 MME Standard Deviation 80.3	102.6 MME Standard Deviation 74.0

SECONDARY outcome

Timeframe: Screening visit

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 T-scores present a worse outcome for anxiety. For the adult PROMIS Anxiety 8a short form values reported, the participants raw scores are converted to T-scores and then averaged.

Outcome measures

Outcome measures
Measure	nCAP + ERAS n=38 Participants 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). nCAP Signal Relief Patch: 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) Standard of Care: 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.	ERAS Alone n=31 Participants Participants randomized into the control group will receive complete Enhanced Recovery After Surgery (ERAS) standard of care and no nCAP patch. Standard of Care: 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.
Pre-operative Emotional Distress Related to Anxiety	48.0 T-score Standard Deviation 6.0	44.1 T-score Standard Deviation 7.5

SECONDARY outcome

Timeframe: Day of surgery up to 30 days post-operative

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 T-scores present a worse outcome for anxiety. For the adult PROMIS Anxiety 8a short form values reported, the participants raw scores are converted to T-scores and then averaged.

Outcome measures

Outcome measures
Measure	nCAP + ERAS n=38 Participants 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). nCAP Signal Relief Patch: 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) Standard of Care: 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.	ERAS Alone n=31 Participants Participants randomized into the control group will receive complete Enhanced Recovery After Surgery (ERAS) standard of care and no nCAP patch. Standard of Care: 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.
Post-operative Change in Emotional Distress Related to Anxiety	9.85 units on a scale Standard Deviation 3.31	9.68 units on a scale Standard Deviation 2.93

SECONDARY outcome

Timeframe: Screening visit

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 T-scores present a worse outcome for depression. For the adult PROMIS Depression 8a short form values reported, the participants raw scores are converted to T-scores and then averaged.

Outcome measures

Outcome measures
Measure	nCAP + ERAS n=38 Participants 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). nCAP Signal Relief Patch: 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) Standard of Care: 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.	ERAS Alone n=31 Participants Participants randomized into the control group will receive complete Enhanced Recovery After Surgery (ERAS) standard of care and no nCAP patch. Standard of Care: 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.
Pre-operative Emotional Distress Related to Depression	41.9 T-score Standard Deviation 7.1	40.4 T-score Standard Deviation 4.7

SECONDARY outcome

Timeframe: Day of surgery up to 30 days post-operative

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 T-scores present a worse outcome for depression. For the adult PROMIS Depression 7a short form values reported, the participants raw scores are converted to T-scores and then averaged.

Outcome measures

Outcome measures
Measure	nCAP + ERAS n=38 Participants 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). nCAP Signal Relief Patch: 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) Standard of Care: 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.	ERAS Alone n=31 Participants Participants randomized into the control group will receive complete Enhanced Recovery After Surgery (ERAS) standard of care and no nCAP patch. Standard of Care: 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.
Post-operative Change in Emotional Distress Related to Depression	42.25 T-score Standard Deviation 6.78	41.78 T-score Standard Deviation 6.48

SECONDARY outcome

Timeframe: Screening visit

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. Higher T-scores present a worse outcome for sleep disturbance. For the adult PROMIS Sleep Disturbance 8a short form values reported, the participants raw scores are converted to T-scores and then averaged.

Outcome measures

Outcome measures
Measure	nCAP + ERAS n=38 Participants 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). nCAP Signal Relief Patch: 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) Standard of Care: 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.	ERAS Alone n=31 Participants Participants randomized into the control group will receive complete Enhanced Recovery After Surgery (ERAS) standard of care and no nCAP patch. Standard of Care: 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.
Pre-operative Sleep Disturbance	51.4 T-score Standard Deviation 7.0	47.4 T-score Standard Deviation 9.3

SECONDARY outcome

Timeframe: Day of surgery up to 30 days post-operative

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. Higher T-scores present a worse outcome for sleep disturbance. For the adult PROMIS Sleep Disturbance 8a short form values reported, the participants raw scores are converted to T-scores and then averaged.

Outcome measures

Outcome measures
Measure	nCAP + ERAS n=38 Participants 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). nCAP Signal Relief Patch: 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) Standard of Care: 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.	ERAS Alone n=31 Participants Participants randomized into the control group will receive complete Enhanced Recovery After Surgery (ERAS) standard of care and no nCAP patch. Standard of Care: 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.
Post-operative Change in Sleep Disturbance	49.86 T-score Standard Deviation 8.81	49.11 T-score Standard Deviation 9.12

SECONDARY outcome

Timeframe: Screening visit

Functionality at baseline is assessed by asking the patient the following 3 questions: 1. Are you able to walk 100 feet (No=0, or Yes = 1), 2. Are you able to move up to five steps (No=0, or Yes = 1), and 3. Are you able to raise your leg (No = 0, some = 1, completely = 2). The total score could vary from 0 to 4. Higher scores indicate better functional status.

Outcome measures

Outcome measures
Measure	nCAP + ERAS n=38 Participants 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). nCAP Signal Relief Patch: 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) Standard of Care: 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.	ERAS Alone n=31 Participants Participants randomized into the control group will receive complete Enhanced Recovery After Surgery (ERAS) standard of care and no nCAP patch. Standard of Care: 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.
Average Score of Functionality at Baseline	3.7 units on a scale Standard Deviation 0.6	3.5 units on a scale Standard Deviation 1.0

SECONDARY outcome

Timeframe: Day of surgery up to 30 days post-operative

Functionality post-operative is assessed by asking the patient the following 3 questions: 1. Are you able to walk 100 feet (No=0, or Yes = 1), 2. Are you able to move up to five steps (No=0, or Yes = 1), and 3. Are you able to raise your leg (No = 0, some = 1, completely = 2). The total score could vary from 0 to 4.

Outcome measures

Outcome measures
Measure	nCAP + ERAS n=38 Participants 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). nCAP Signal Relief Patch: 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) Standard of Care: 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.	ERAS Alone n=31 Participants Participants randomized into the control group will receive complete Enhanced Recovery After Surgery (ERAS) standard of care and no nCAP patch. Standard of Care: 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.
Average Score of Functionality Post-Operative	2.8 units on a scale Standard Deviation 0.2	2.7 units on a scale Standard Deviation 0.1

SECONDARY outcome

Timeframe: Screening visit

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.

Outcome measures

Outcome measures
Measure	nCAP + ERAS n=38 Participants 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). nCAP Signal Relief Patch: 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) Standard of Care: 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.	ERAS Alone n=31 Participants Participants randomized into the control group will receive complete Enhanced Recovery After Surgery (ERAS) standard of care and no nCAP patch. Standard of Care: 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.
Pre-operative Pain Rating Using the Pain Catastrophizing Scale	5.8 units on a scale Standard Deviation 6.1	6.8 units on a scale Standard Deviation 8.4

SECONDARY outcome

Timeframe: Day of surgery up to 30 days post-operative

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

Outcome measures

Outcome measures
Measure	nCAP + ERAS n=38 Participants 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). nCAP Signal Relief Patch: 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) Standard of Care: 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.	ERAS Alone n=31 Participants Participants randomized into the control group will receive complete Enhanced Recovery After Surgery (ERAS) standard of care and no nCAP patch. Standard of Care: 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.
Change in Post-operative Pain Rating Using the Pain Catastrophizing Scale	4.3 units on a scale Standard Deviation 5.8	4.6 units on a scale Standard Deviation 6.3

SECONDARY outcome

Timeframe: Day of surgery up to 30 days post-operative

Evaluate time to hospital discharge from out of OR time. This outcome measure will be measured via averaged hours to hospital discharge.

Outcome measures

Outcome measures
Measure	nCAP + ERAS n=38 Participants 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). nCAP Signal Relief Patch: 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) Standard of Care: 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.	ERAS Alone n=31 Participants Participants randomized into the control group will receive complete Enhanced Recovery After Surgery (ERAS) standard of care and no nCAP patch. Standard of Care: 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.
Length of Hospital Stay	31.72 hours Standard Deviation 22.0	40.85 hours Standard Deviation 36.23

SECONDARY outcome

Timeframe: Days 1-30 post-operative

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 outcome measure is an area under the curve from POD 1 to POD 30, with the unit of pain per day being measure 0-300 (scale of 0-10 for 30 days).

Outcome measures

Outcome measures
Measure	nCAP + ERAS n=38 Participants 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). nCAP Signal Relief Patch: 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) Standard of Care: 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.	ERAS Alone n=31 Participants Participants randomized into the control group will receive complete Enhanced Recovery After Surgery (ERAS) standard of care and no nCAP patch. Standard of Care: 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.
Change in Post-operative Pain Using a Numerical Rating Scale	59.4 Scores X Day Standard Deviation 41.6	101.5 Scores X Day Standard Deviation 75.8

Adverse Events

nCAP + ERAS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

ERAS Alone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Amy Monroe

UPMC

Phone: 412-623-6382

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place