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.
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 addition to the conventional methods of pain relief such as continuous epidural block, intrathecal adjuvants, femoral nerve block ± sciatic nerve block, transcutaneous electrical nerve stimulation (TENS) and percutaneous electrical neurostimulation (PENS) have been reported effective by various authors. Recently neurostimulation of auricular nerves via the external auricular surface has shown to alleviate pain after caesarian section. Primary Relief® is percutaneous electrical neuro stimulator designed to administer auricular neurostimulation treatment over 240 hours. Stimulation is performed by sending electrical pulses emitted through needles strategically positioned in the ear. The ear provides numerous points for stimulation within a small area Based on the area of pain relief, chosen points are stimulated. Primary Relief is a miniaturized device designed to administer PENS treatment. Use of this device is recommended for pre-operative, intra-operative and post-operative pain therapy as well as for the treatment of chronic pain. An advantage over drug therapy is that it avoids the possible side-effects of analgesics and helps in early mobilization following orthopedic surgeries including total knee replacement (TKR), total hip replacement (THR) and shoulder surgeries. Therefore, this study is being undertaken to assess the effect of Primary Relief ® in augmenting pain relief after TKR surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
44
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).
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).
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).
Time frame: 0 - 3 days ; 0,2,4,6,8,10,12,18,24,36,48,60,72 hrs from the time of completion of surgery
NPRS Numerical Pain Rating Scale score post-mobilization
To evaluate the effect of treatment in reducing the average NPRS scores after mobilization. The measurement will record the daily NPRS scores from day three to ten days.
Time frame: 4 - 10 days ; 96,120,144,168,192,216,240 hrs from the time of completion of surgery)
Total Use of Analgesics and Opioids
To evaluate the effect of treatment in reducing the overall analgesic and opioid requirement in the immediate postoperative period. The measurement will record the total dose and number of additional analgesics required during the immediate postoperative period at rest.
Time frame: OVERALL DOSE IN FIRST 3 DAYS & OVERALL DOSE REQUIRED BETWEEN 4 TO 10 DAYS
KOOS Score The Knee injury and Osteoarthritis Outcome Score ( koos)
To assess the effect of treatment in Quality of life during postoperative period, using the knee injury and osteoarthritis outcome score (KOOS)
Time frame: 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)
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