NCT05416294

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: DyAnsys, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Arthroplasty, Knee Replacement

Interventions

Type	Name	Description
DEVICE	Primary Relief	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).
DEVICE	Inactive Primary Relief	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).

Timeline

• Start date: 2022-08-15
• Primary completion: 2022-09-15
• Completion: 2022-09-30
• First posted: 2022-06-13
• Last updated: 2022-07-29