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

NACompletedINTERVENTIONAL
Enrollment

79

Participants

Timeline

Start Date

March 21, 2022

Primary Completion Date

October 8, 2022

Study Completion Date

October 8, 2022

Conditions
Opioid UsePain, Post Operative
Interventions
DEVICE

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)

OTHER

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.

Trial Locations (1)

15232

UPMC Shadyside Hospital, Pittsburgh

All Listed Sponsors
collaborator

nCap Medical

INDUSTRY

lead

Jacques E. Chelly

OTHER