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

NCT05252858 | Completed Results DMC FDA Device

• 1 other identifier: STUDY22010018
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Opioid Use; Pain, Post Operative

Keywords

Joint replacement surgery; Post operative pain management; Neuro capacitor

Outcome Measures

Primary Outcomes (1)

• 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.

  Day of surgery up to 30 days post-operative

Secondary Outcomes (12)

• Pre-operative Emotional Distress Related to Anxiety

  Screening visit

• Post-operative Change in Emotional Distress Related to Anxiety

  Day of surgery up to 30 days post-operative

• Pre-operative Emotional Distress Related to Depression

  Screening visit

• Post-operative Change in Emotional Distress Related to Depression

  Day of surgery up to 30 days post-operative

• Pre-operative Sleep Disturbance

  Screening visit

Study Arms (2)

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).

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.

Other: Standard of Care

Interventions

nCAP Signal Relief Patch DEVICE

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)

Also known as: nCAP, treatment patch

nCAP + ERAS

Standard of Care OTHER

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.

Also known as: Enhanced Recovery After Surgery (ERAS)

ERAS alone; nCAP + ERAS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>18 years of age
• Scheduled for elective primary unilateral hip or knee replacement

You may not qualify if:

• 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

Sponsors & Collaborators

• Jacques E. Chelly: lead
• nCap Medical: collaborator

Study Sites (1)

UPMC Shadyside Hospital

Pittsburgh, Pennsylvania, 15232, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Standard of Care; Enhanced Recovery After Surgery

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Perioperative Care; Surgical Procedures, Operative

Limitations and Caveats

Although the present study is the first prospective, randomized study on the use of the NeuroCupleTM device, our data will need to be confirmed by a larger randomized placebo-controlled study.

Results Point of Contact

• Title: Amy Monroe
• Organization: UPMC

monroeal@upmc.edu

412-623-6382

Study Officials

• Jacques E Chelly, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Anesthesiology and Perioperative Medicine and Orthopedic Surgery Director, Regional Anesthesiology Fellowship Program

Model Details: 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

Study Record Dates

• First Submitted: February 3, 2022
• First Posted: February 23, 2022
• Study Start: March 21, 2022
• Primary Completion: October 8, 2022
• Study Completion: October 8, 2022
• Last Updated: April 18, 2024
• Results First Posted: April 18, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)