The Effect of RF Genicular Nerve Block Applied in the Preoperative Period on Fast-track Total Knee Arthroplasty

Knee Osteoarthritis Clinical Trial

Official title:

The Effect of RF Genicular Nerve Block Applied in the Preoperative Period on Fast-track Total Knee Arthroplasty

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06239649
• Other study ID #: 2023PAUOrto
• Status: Recruiting
• Start date: October 19, 2023
• Est. completion date: July 31, 2024

Study information

• Verified date: January 2024
• Source: Pamukkale University
• Contact: HARUN R GUNGOR, MD
• Phone: 258-296-5690
• Email: hrgungor[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Knee Pain Chronic
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Procedure:
• Genicular nerve Radiofrequency Ablation block
Genicular nerve Radiofrequency Ablation block

Locations

Country	Name	City	State
Turkey	Pamukkale University	Denizli	Pamukkale

Sponsors (1)

Lead Sponsor	Collaborator
Pamukkale University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain preoperative	Visual Analog Scale used to assess pain	Baseline (preoperatively)
Primary	Pain postoperative 1	Visual Analog Scale used to assess pain	at postoperative sixth weeks
Primary	Pain postoperative 2	Visual Analog Scale used to assess pain	at postoperative twelfth weeks
Primary	Knee Range of Motion preoperative	Digital goniometer used to assess knee range of motion	Baseline (preoperatively)
Primary	Knee Range of Motion postoperative 1	Digital goniometer used to assess knee range of motion	at postoperative sixth week
Primary	Knee Range of Motion postoperative 2	Digital goniometer used to assess knee range of motion	at postoperative twelfth week
Primary	Quadriceps muscle strength preoperative	Quadriceps muscle strength is measured (unit=newton(N)) with hand-held dynamometer	Baseline (preoperatively)
Primary	Quadriceps muscle strength postoperative 1	Quadriceps muscle strength is measured (unit=newton(N)) with hand-held dynamometer	at postoperative sixth weeks
Primary	Quadriceps muscle strength postoperative 2	Quadriceps muscle strength is measured (unit=newton(N)) with hand-held dynamometer	at postoperative twelfth week
Primary	Patient-reported activity limitations preoperative	The Western Ontario and McMaster Universities Arthritis Index and Knee injury and Osteoarthritis Outcome Score are used	Baseline (preoperatively)
Primary	Patient-reported activity limitations preoperative 1	The Western Ontario and McMaster Universities Arthritis Index and Knee injury and Osteoarthritis Outcome Score are used	at postoperative sixth weeks
Primary	Patient-reported activity limitations preoperative 2	The Western Ontario and McMaster Universities Arthritis Index and Knee injury and Osteoarthritis Outcome Score are used	at postoperative twelfth week
Primary	Performance-based activity limitations-preoperative	30-sec chair-stand test and stair-climb test are used	Baseline (preoperatively)
Primary	Performance-based activity limitations-preoperative 1	30-sec chair-stand test and stair-climb test are used	at postoperative sixth weeks
Primary	Performance-based activity limitations-preoperative 2	30-sec chair-stand test and stair-climb test are used	at postoperative twelfth week
Primary	Quality of life-preoperative	Short Form-36 (SF-36) is used	Baseline (preoperatively)
Primary	Quality of life-preoperative 1	Short Form-36 (SF-36) is used	at postoperative sixth weeks
Primary	Quality of life-preoperative 2	Short Form-36 (SF-36) is used	at postoperative twelfth week
Primary	Length of hospital stay	Length of hospital stay is measured beginning from the hospitalization of the patient and ending at discharge of the patients (unit-hours)	through study completion, an average of 1 year
Secondary	Length of operation time	Length of operation time is measured in minutes during the surgery	the surgery
Secondary	Amount of blood loss	Amount of blood loss is measured from the suction drainage (unit-milliliters)	through study completion, an average of 1 year
Secondary	postoperative component alignments	Long leg radiographs of the patients are evaluated postoperatively by using a digital orthopedic templating software-Materialise OrthoView (OrthoView version 7, Materialise HQ, Technologielaan 15 3001 Leuven, Belgium).	through study completion, an average of 1 year