Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 1:33 AM
NCT ID:
NCT05416294
Eligibility Criteria:
Inclusion Criteria:
Patients undergoing TKR under regional or general anesthesia and femoral nerve block who consent to participate in the study.
Exclusion Criteria:
* ASA 3 or 4
* Those receiving psychiatric medication
* Those with infection at the site of application.
The following data will be collected
* Intraoperative use of local anesthetics, opioids and other analgesics
* Postoperative details as to the time of application of the device. NPRS in both the groups at multiple intervals, on demand analgesic requirement, overall analgesic consumption during the study period, quality of life questionnaire at the end of the study period and relevant postoperative complications will be noted.
* Rescue analgesics will be considered for breakthrough pain or NPRS \> 4. Intravenous Tramadol 50mg will be the first rescue analgesic and if pain is not relieved with Tramadol, opiods will be considered. Non steroidal anti inflammatory drugs will be considered to supplement the above medications if there is no contraindication and if need arises.
* NPRS score will be noted at multiple intervals for 10 days.
* Any nausea, vomiting, giddiness, intolerance to the device will also be noted.
* During the follow up, quality of life questionnaire would be administered and the result noted.
The device will be removed after 10 days of its application. Any redness at the site of application or pain at the site are noted. The study will end with the removal of the device.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05416294
Study Brief:
Protocol Section:
NCT05416294