Multi-center, randomized, blinded, sham-controlled study to determin the safety and efficacy of the NOVABLOC system on post-operative pain in patients undergoing TKA procedures.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
120
Percutaneous radiofrequency electrical nerve stimulation will be applied to the femoral and sciatic nerves prior to TKA.
Electrical square wave stimulation performed to mimic the duration of the active arm and mimic the procedure for blinding purposes.
Alabama Orthopedic Sports Medicine & Baldwin County Surgery Center
Daphne, Alabama, United States
RECRUITINGWorst Pain at Day 10
The worst pain felt by each subject at day 10 after the TKA procedure (as measured by question 3 on the BPI)
Time frame: 10 days post-TKA
Total morphine equivalents used
Total morphine equivalents used cumulatively through Day 5
Time frame: 5 days post-TKA
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