Opioid UseNCT05252858
A Pilot Study Investigating the nCAP Signal Relief Patch in Subjects Undergoing Primary Hip or Knee Replacement Surgery
A study testing nCAP Signal Relief Patch in people with Opioid Use and Pain, Post Operative, run by Jacques E. Chelly at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use, Pain, Post Operative
- What is being tested?
- nCAP Signal Relief Patch
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Mar 2022to 8 Oct 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >18 years of age
- Scheduled for elective primary unilateral hip or knee replacement
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
UPMC Shadyside Hospital
Pittsburgh, Pennsylvania, 15232
About this study
Official 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
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.
Read the detailed description
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.
- Conditions
- Opioid Use, Pain, Post Operative
- Being tested
- nCAP Signal Relief Patch, Standard of Care
- Keywords
- Joint replacement surgery, Post operative pain management, Neuro capacitor
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nCAP Signal Relief PatchDevice
Also called nCAP, treatment 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 CareOther
Also called Enhanced Recovery After Surgery (ERAS)
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.
| Study group | Role | What they receive |
|---|---|---|
| nCAP + ERAS | Experimental | 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). Receives: Device: nCAP Signal Relief Patch; Other: Standard of Care |
| ERAS alone | Active comparator | Participants randomized into the control group will receive complete Enhanced Recovery After Surgery (ERAS) standard of care and no nCAP patch. Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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) from the day of surgery up to day 30 post-operative. Opioid requirement will be estimated following the placement of the patch.
Measured: Day of surgery up to 30 days post-operative
Secondary outcomes (12)
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 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.
Measured: 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 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.
Measured: Day of surgery up to 30 days 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 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.
Measured: 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 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.
Measured: Day of surgery up to 30 days 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. 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.
Measured: 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. 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.
Measured: Day of surgery up to 30 days post-operative
Average Score of Functionality at Baseline
Functionality at baseline is assessed by asking the patient the following 3 questions:
- Are you able to walk 100 feet (No=0, or Yes = 1),
- Are you able to move up to five steps (No=0, or Yes = 1), and
- 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.
Measured: Screening visit
Average Score of Functionality Post-Operative
Functionality post-operative is assessed by asking the patient the following 3 questions:
- Are you able to walk 100 feet (No=0, or Yes = 1),
- Are you able to move up to five steps (No=0, or Yes = 1), and
- Are you able to raise your leg (No = 0, some = 1, completely = 2).
The total score could vary from 0 to 4.
Measured: Day of surgery up to 30 days 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.
Measured: 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
Measured: Day of surgery up to 30 days post-operative
Length of Hospital Stay
Evaluate time to hospital discharge from out of OR time. This outcome measure will be measured via averaged hours to hospital discharge.
Measured: Day of surgery up to 30 days 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 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).
Measured: Days 1-30 post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2022
- Study start21 Mar 2022
- Primary completion8 Oct 2022
- Study completion8 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Opioid UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jacques E. Chelly
- Sponsor type
- University, hospital or other
- Collaborators
- nCap Medical
- Responsible party
- Sponsor-investigator, Jacques E. Chelly, University of Pittsburgh
- Investigators
- Jacques E Chelly, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05252858
- Sponsor's protocol ID
- STUDY22010018
- Status last verified
- Apr 2024
- First submitted
- 3 Feb 2022
- Last updated
- 18 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05252858
- Acronym / sponsor ID
- STUDY22010018
- Conditions
- Opioid Use, Pain, Post Operative
- Keywords
- Joint replacement surgery, Post operative pain management, Neuro capacitor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Jacques E. ChellyUniversity, hospital or other
- Collaborators
- nCap Medical
- Study start
- 21 Mar 2022 (actual)
- Primary completion
- 8 Oct 2022 (actual)
- Study completion
- 8 Oct 2022 (actual)
- First posted
- 23 Feb 2022 (actual)
- Results
- Posted 18 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| nCAP + ERAS | Experimental | Device: nCAP Signal Relief Patch, Other: Standard of CareParticipants 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). |
| ERAS alone | Active comparator | Other: Standard of CareParticipants randomized into the control group will receive complete Enhanced Recovery After Surgery (ERAS) standard of care and no nCAP patch. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- >18 years of age
- Scheduled for elective primary unilateral hip or knee replacement
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nCAP Signal Relief PatchAlso: nCAP, treatment patchnCAP Signal Relief Patch post-operatively applied to the subject's surgical dressing by a trained researcher in the immediate Post Anesthesia Care Unit (PACU) | Device | nCAP + ERAS |
| Standard of CareAlso: Enhanced Recovery After Surgery (ERAS)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. | Other | ERAS alone, nCAP + ERAS |
Primary outcome
Efficacy of the nCAP Signal Relief Patch in Affecting Perioperative Opioid Requirement
Time frame: Day of surgery up to 30 days post-operative
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.
12 secondary outcomes
Pre-operative Emotional Distress Related to Anxiety
Time frame: Screening visit
Post-operative Change in Emotional Distress Related to Anxiety
Time frame: Day of surgery up to 30 days post-operative
Pre-operative Emotional Distress Related to Depression
Time frame: Screening visit
Post-operative Change in Emotional Distress Related to Depression
Time frame: Day of surgery up to 30 days post-operative
Pre-operative Sleep Disturbance
Time frame: Screening visit
Post-operative Change in Sleep Disturbance
Time frame: Day of surgery up to 30 days post-operative
Average Score of Functionality at Baseline
Time frame: Screening visit
Average Score of Functionality Post-Operative
Time frame: Day of surgery up to 30 days post-operative
Pre-operative Pain Rating Using the Pain Catastrophizing Scale
Time frame: Screening visit
Change in Post-operative Pain Rating Using the Pain Catastrophizing Scale
Time frame: Day of surgery up to 30 days post-operative
Length of Hospital Stay
Time frame: Day of surgery up to 30 days post-operative
Change in Post-operative Pain Using a Numerical Rating Scale
Time frame: Days 1-30 post-operative
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacques E Chelly, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nCAP Signal Relief Patch in people with Opioid Use and Pain, Post Operative, run by Jacques E. Chelly at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of the nCAP Signal Relief Patch in Affecting Perioperative Opioid Requirement (time frame: Day of surgery up to 30 days post-operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2024.