Event Group
Event Groups are part of the Adverse Events Module within the Results Section. They provide a way to organize and summarize adverse event data by grouping related events together.
Each Event Group typically represents a category or class of adverse events and includes statistical information such as the number of participants affected and at risk for different event types: deaths, serious events, and other events.
Event Group path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Group
Event Group
Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2025-12-25 @ 10:19 PM
NCT ID:
NCT05252858
Group ID:
EG000
Title:
nCAP + ERAS
Description:
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.
Deaths Number Affected:
0
Deaths Number At Risk:
None
Serious Number Affected:
0
Serious Number At Risk:
38
Other Number Affected:
0
Other Number At Risk:
38
Study:
NCT05252858
Results Section:
NCT05252858
Adverse Events Module:
NCT05252858