Status:
UNKNOWN
Neurostimulation an Adjuvant Postoperative Analgesic in Total Knee Replacement (TKR) Surgeries
Lead Sponsor:
DyAnsys, Inc.
Conditions:
Arthroplasty, Knee Replacement
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
To study and evaluate the effect of using the Primary Relief PENS treatment as adjuvant analgesia for reducing pain in total knee replacement (TKR) patients.
Detailed Description
It is a common knowledge that total knee replacement (TKR) surgeries produce great deal of pain in the postoperative period. Superior pain relief is justifiably needed and usually provided. In additio...
Eligibility Criteria
Inclusion
- Patients undergoing TKR under regional or general anesthesia and femoral nerve block who consent to participate in the study.
Exclusion
- 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.
Key Trial Info
Start Date :
August 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2022
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT05416294
Start Date
August 15 2022
End Date
September 30 2022
Last Update
July 29 2022
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