Neurostimulation an Adjuvant Postoperative Analgesic in Total Knee Replacement (TKR) Surgeries

NCT05416294 | Unknown

• 1 other identifier: CS014
• Study Type: interventional
• Target: 44
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Arthroplasty, Knee Replacement

Keywords

Knee Replacement

Outcome Measures

Primary Outcomes (1)

• Numerical Pain Rating Scale (NPRS)

  To evaluate the pain score in the immediate postoperative period. Pain Score with will be measured on a scale (0 = no pain; 10 = worst imaginable pain).

  0 - 3 days ; 0,2,4,6,8,10,12,18,24,36,48,60,72 hrs from the time of completion of surgery

Secondary Outcomes (3)

• NPRS Numerical Pain Rating Scale score post-mobilization

  4 - 10 days ; 96,120,144,168,192,216,240 hrs from the time of completion of surgery)

• Total Use of Analgesics and Opioids

  OVERALL DOSE IN FIRST 3 DAYS & OVERALL DOSE REQUIRED BETWEEN 4 TO 10 DAYS

• KOOS Score The Knee injury and Osteoarthritis Outcome Score ( koos)

  5 times planned from 0 - 10 day; (i) 24 hrs before Surgery; (ii) 24 Hrs after completion of surgery; (iii) 72 hrs after completion of Surgery; (iv) 120 hrs after completion of Surgery; (v) At the time of device removal -@240 hrs)

Study Arms (2)

Active Device

EXPERIMENTAL

Participants in this arm will receive an active Primary Relief device placed following the total knee replacement surgery.

Device: Primary Relief

Placebo Device

SHAM COMPARATOR

Participants in this arm will receive an inactive (sham) Primary Relief device placed following the total knee replacement surgery.

Device: Inactive Primary Relief

Interventions

Primary Relief DEVICE

The group will receive PENS treatment using Primary Relief in addition to the multimodal analgesia (morphine, ketorolac, methyl, prednisolone, adrenaline) including the periarticular infiltration of local anaesthetic and/or femoral or epidural catheter for postoperative pain management (bupivacaine, ropivacaine).

Active Device

Inactive Primary Relief DEVICE

The group will receive a sham device with multimodal analgesia (morphine, ketorolac, methyl, prednisolone, adrenaline), including the periarticular infiltration of local anaesthetic and/or femoral or epidural catheter for postoperative pain management (bupivacaine, ropivacaine).

Placebo Device

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing TKR under regional or general anesthesia and femoral nerve block who consent to participate in the study.

You may not qualify if:

• 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.

Sponsors & Collaborators

• DyAnsys, Inc.: lead

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: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2022
• First Posted: June 13, 2022
• Study Start: August 15, 2022
• Primary Completion: September 15, 2022
• Study Completion: September 30, 2022
• Last Updated: July 29, 2022

Record last verified: 2022-07