Clinical trial NCT06239649: The Effect of RF Genicular Nerve Block Applied in the Preoperative Period on Fast-track Total Knee Arthroplasty
Official title: The Effect of RF Genicular Nerve Block Applied in the Preoperative Period on Fast-track Total Knee Arthroplasty
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Knee Osteoarthritis
Knee Pain Chronic
Keywords: Fast-Track Total Knee Arthroplasty
Genicular Nerve Block
Radiofrequency Ablation
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2024-02-02
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Inclusion Criteria:

* Being between the ages of 40 and 85,
* Being able to understand verbal and written information given in Turkish,
* Being able to speak and understand Turkish,
* Being subjected to unilateral TKA surgery due to the diagnosis of Primary Knee osteoarthritis

Brief summary: In our study, investigators plan to compare the preoperative RF and genicular nerve ablation approach in patients who underwent TKA(Total Knee Arthroplasty) using the Fast-Track protocol in terms of meeting postoperative pain, function and early discharge criteria.

Detailed description: One of the most important components of surgery using Fast-Track is the application of effective and well-monitored pain treatment. Post-surgical pain negatively affects the patient's early mobilization. Reduction in pain after TKA(Total Knee Arthroplasty) may not only increase short-term functional results but also increase the patient's overall satisfaction.

Genicular Nerve Radiofrequency Ablation (GNRFA) is a non-surgical treatment increasingly used in patients with advanced knee osteoarthritis. Previous studies have shown this to be an effective and safe method to reduce pain and improve functionality in this patient population.

Neurolysis of genicular nerves with radiofrequency (RF) may be useful to relieve pain and improve both function and quality of life in patients with post-TKA pain.

Investigators thought that reducing the pain of patients who underwent TKA with Fast-track in the postoperative period would contribute to early mobilization and therefore rapid functional recovery. As a result of previous studies, investigators know that genicular nerve neurolysis with RF Ablation in the preoperative period provides a reduction in postoperative pain.

Investigators routinely apply TKA applications in clinic with Fast-Track. In investigators hospital's algology outpatient clinic, genicular nerve RF ablation is routinely performed under USG or fluoroscopy guidance. In investigators study, investigators plan to compare the preoperative RF and genicular nerve ablation approach in patients who underwent TKA using the Fast-Track protocol in terms of meeting postoperative pain, function and early discharge criteria

Eligibility criteria: Inclusion Criteria:

* Being between the ages of 40 and 85,
* Being able to understand verbal and written information given in Turkish,
* Being able to speak and understand Turkish,
* Being subjected to unilateral TKA surgery due to the diagnosis of Primary Knee osteoarthritis

Exclusion Criteria:

* Patients planned for revision knee prosthesis surgery,
* Patients previously diagnosed with psychiatric disorders,
* Patients who have undergone major surgery on the extremity where TKA will be applied,
* Patients with comorbid diseases such as rheumatoid arthritis or cancer,
* Patients with a score above 3 according to the American Society of Anesthesiologists (ASA) scoring,
* Patients with neurological diseases that cause functional disability,
* Patients with flexion limitation of more than 45 degrees and extension limitation of more than 20 degrees,
* Patients who have to use hypnotic or anxiolytic drugs regularly,
* Patients with alcohol or drug addiction,
* Patients with bleeding disorders
* Patients with uncontrolled diabetes

Primary outcomes:
measure: Pain preoperative
timeFrame: Baseline (preoperatively)
measure: Pain postoperative 1
timeFrame: at postoperative sixth weeks
measure: Pain postoperative 2
timeFrame: at postoperative twelfth weeks
measure: Knee Range of Motion preoperative
timeFrame: Baseline (preoperatively)
measure: Knee Range of Motion postoperative 1
timeFrame: at postoperative sixth week
measure: Knee Range of Motion postoperative 2
timeFrame: at postoperative twelfth week
measure: Quadriceps muscle strength preoperative
timeFrame: Baseline (preoperatively)
measure: Quadriceps muscle strength postoperative 1
timeFrame: at postoperative sixth weeks
measure: Quadriceps muscle strength postoperative 2
timeFrame: at postoperative twelfth week
measure: Patient-reported activity limitations preoperative
timeFrame: Baseline (preoperatively)
measure: Patient-reported activity limitations preoperative 1
timeFrame: at postoperative sixth weeks
measure: Patient-reported activity limitations preoperative 2
timeFrame: at postoperative twelfth week
measure: Performance-based activity limitations-preoperative
timeFrame: Baseline (preoperatively)
measure: Performance-based activity limitations-preoperative 1
timeFrame: at postoperative sixth weeks
measure: Performance-based activity limitations-preoperative 2
timeFrame: at postoperative twelfth week
measure: Quality of life-preoperative
timeFrame: Baseline (preoperatively)
measure: Quality of life-preoperative 1
timeFrame: at postoperative sixth weeks
measure: Quality of life-preoperative 2
timeFrame: at postoperative twelfth week
measure: Length of hospital stay
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Length of operation time
timeFrame: the surgery
measure: Amount of blood loss
timeFrame: through study completion, an average of 1 year
measure: postoperative component alignments
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Denizli
country: Turkey
facility: Pamukkale University
state: Pamukkale
Study officials:
References:
citation: Stake S, Agarwal AR, Coombs S, Cohen JS, Golladay GJ, Campbell JC, Thakkar SC. Total Knee Arthroplasty After Genicular Nerve Radiofrequency Ablation: Reduction in Prolonged Opioid Use Without Increased Postsurgical Complications. J Am Acad Orthop Surg Glob Res Rev. 2022 Aug 12;6(8):e22.00125. doi: 10.5435/JAAOSGlobal-D-22-00125. eCollection 2022 Aug 1.
citation: Lloyd JM, Wainwright T, Middleton RG. What is the role of minimally invasive surgery in a fast track hip and knee replacement pathway? Ann R Coll Surg Engl. 2012 Apr;94(3):148-51. doi: 10.1308/003588412X13171221590214.
citation: Sullivan M, Tanzer M, Reardon G, Amirault D, Dunbar M, Stanish W. The role of presurgical expectancies in predicting pain and function one year following total knee arthroplasty. Pain. 2011 Oct;152(10):2287-2293. doi: 10.1016/j.pain.2011.06.014. Epub 2011 Jul 18.