1. Title of Project: Study of outcome & efficacy of genicular nerve block versus saphenous nerve block in osteoarthritis of knee: a prospective randomized controlled trial.

2.  Applicant: Dr. Arun Kumar Ojha, Junior Resident, Department of Physical Medicine and Rehabilitation, KGMU, Lucknow.

     Mobile no. 9643908361   

     Email ID: arun.ojha29@gmail.com

3. Investigators (Name & Affiliation):

GUIDE: Dr.Ganesh Yadav, Associate Professor, Department of Physical Medicine and Rehabilitation, KGMU, Lucknow

CO-GUIDE: Dr.Anil Kumar Gupta, Professor & Head, Department of Physical Medicine and Rehabilitation, KGMU, Lucknow.

CO-GUIDE: Dr.Puneet Kumar, Associate Professor, Department of Clinical Immunology and Rheumatology, KGMU, Lucknow.

CO-GUIDE: Dr.Sanjai Singh,  Assistant Professor, Department of Physical Medicine and Rehabilitation, KGMU, Lucknow.

4. Collaborators (if any): None

5. Potential Funding Agency:N.A

6. Background and Brief Review of Literature with references: 

Osteoarthritis (OA) knee is a Chronic & Progressive softening & disintegration of articular cartilage accompanied by new growth of cartilage & bone at the joint margins (Osteophytes), cyst formation & sclerosis in the subchondral bone, mild synovitis & capsular fibrosis [1].

OA knee is not purely degenerative disorder, it includes both phenomenon of Destruction and Repair. The process of new bone formation becomes Hyperactive along with Cartilage softening and Disintegration i.e., Osteophytosis & Remodeling. Knee OA is the most prevalent condition resulting to disability particularly in elderly population. In a study the overall prevalence of knee OA in Indian population was found to be 15% [2].

About 13% of women and 10% of men aged 60 years and older have symptomatic knee OA.Knee Osteoarthritis represents 83% of total Osteoarthritis [3,4]. 

Common etiologies of Secondary Osteoarthritis of the Knee are: Post-traumatic, Congenital Malformation, Malposition(Varus/Valgus), Postoperative, Metabolic(Rickets, Hemochromatosis, Chondrocalcinosis, Ochronosis), Endocrine Disorders (Acromegaly, Hyperparathyroidism, Hyperuricemia), Aseptic Osteonecrosis. Persistent knee pain, Limited morning stiffness & Reduced function are the three symptoms that are recommended for the diagnosis of knee OA by the EULAR [5]. 

There is no single approach for managing knee osteoarthritis pain that will work for everyone. A combination of non-surgical treatment is usually necessary for effective pain relief. Additionally, a period of trial-and-error may be needed to find treatment that address specific symptoms. There are multiple study suggesting the beneficial effect of genicular nerve block & saphenous nerve block either of corticosteroid or neurolytic or ablative agent but there is no literature which has compared between these two lines of management. Thus, this assessment would broaden the existing treatment options for the management of Osteoarthritis knee pain.

Importance of the research proposal: The study can contribute to the growing body of evidence on the efficacy of Genicular and Saphenous nerve blocks in pain management and lead to the development of better treatment options for patients with osteoarthritis of the knee.

7. Hypothesis and Objectives:       

Research Hypothesis:

Null Hypothesis: There should not be any significant difference in the efficacy of genicular nerve block and saphenous nerve block in osteoarthritis of knee.

Alternative Hypothesis: There should be a significant difference in the efficacy of genicular nerve block and saphenous nerve block in osteoarthritis of knee.

 Objectives:

To determine the Functional improvement & Effect in patients with Osteoarthritis knee after:

i)Saphenous nerve block,

ii)Genicular Nerve Block,

iii)Compare outcome & Efficacy between Saphenous Nerve block versus Genicular Nerve Block.

8. Study design and methods:

Study Settings: The study will be conducted in Department of Physical Medicine and Rehabilitation, in collaboration with Department of Clinical Immunology and Rheumatology, King George’s Medical University, Lucknow.

Study design: A prospective randomized controlled trial.

Study duration: 18 months.

Sample size: 54 (27 in each group).

METHODOLOGY:

After taking approval from the institutional ethics committee, patient enrolment will be done after taking informed consent.

After inclusion, computer-generated randomization will be done, and patients will be divided into two groups of 27 each, i.e., the Genicular Nerve Block group and the Saphenous Nerve Block group.

All patient’s clinico-demographic profiles will be recorded.

In Saphenous Nerve Block group:-patient will be administered a mixture of 4 mL of Bupivacaine + 1 ml Triamcinolone (TA) 40mg.

In Genicular Nerve Block group:-patients will be administered 2ml from a combination prepared with 5 ml of Bupivacaine + 1 ml of Triamcinolone 40mg at three separate target sites, i.e., the Superior lateral, Superior medial, and Inferior medial genicular nerves.

The efficacy of Nerve block on Nociceptive pain reduction will be measured by Numeric Pain Rating Scale (NPRS).

The efficacy of Nerve Block on physical function will be measured by Knee Injury and Osteoarthritis Outcome Score (KOOS).

Patients will be followed in 1^st, 4^th and 8^th week.

9. Intervention:  None

10. Setting:  A prospective randomized controlled trial

11. Inclusion and Exclusion criteria:

Inclusion Criteria:

Age of patients:Between 50 to 75 years.

Diagnosed case of Unilateral/Bilateral OA knee by Radiograph (Kellgren & Lawrence Grading ≥2).

Chronic knee pain lasting over 3 months.

Exclusion criteria:

Acute knee pain/ knee effusion.

Any prior knee surgery.

History of intraarticular and/or periarticular injection previous 12 weeks.

Progressive neurological disease.

Vascular disease.

Fracture around knee.

Psychiatric disorders.

Diabetic patients with HbA1c >7.0.

Signs of Injection site infection.

History of Bleeding disorders.

History of Hypersensitivity with Steroids & Local Anaesthetic drugs.

Patient who refused to participate in study.

12. Sample size for primary outcomes: Sample size is calculated on the basis of variation in VAS after last follow up among the study groups using the formula.

Where, d = mean (s₁, s₂), the difference considered to be clinically significant.

k = 1.0 the design effect.

type I error Î± = 5% corresponding to 95% confidence level.

type II error Î² = 10% for detecting results with 90% power of study.

So, the required sample size:   n = 27 each group.

s₁ = 1.35, The SD of VAS in Genicular Nerve Block group after last follow up [6].

s₂ = 2.11, The SD of VAS in Saphenous Nerve Block group after last follow up [7].

13. Data Management and Analysis:

Data entry:Data collected will be entered in Microsoft excel 2019 software.

Statistical analysis:SPSS latest available version and MS Excel will be used for statistical analysis of the data. Continuous variables conforming to a normal distribution will be expressed as mean ± standard deviation. Counting data will be expressed as number and percentages. The unpaired t-test/repeated measures ANOVA or its non-parametric equivalents will be used for intergroup and intragroup analysis. The χ2 test will be used to compare the proportion data between the groups. Other appropriate statistical tests will be used. In all of the statistical analyses, P < 0.05 will be considered to be statistically significant.

14. Ethical clearances: Applied & Approved on 15/12/2023.

15. Time Line: 18 months

16. Budget:N.A 

REFERENCES

1.     Eaton CB. Obesity as a risk factor for osteoarthritis: mechanical versus metabolic. Rhode Island Medical Journal. 2004 Jul 1;87(7):201.

2.     Kumar P, Alok R, Das SK, Srivastava R, Agarwal GG. Distribution of rheumatological diseases in rural and urban areas: an adapted COPCORD Stage I Phase III survey of Lucknow district in north India. International journal of rheumatic diseases. 2018 Nov;21(11):1894-9.

3.     Zhang Y, Jordan JM. Epidemiology of osteoarthritis. Clinics in geriatric medicine. 2010 Aug 1;26(3):355-69.

4.     Bliddal H, Christensen R. The treatment and prevention of knee osteoarthritis: a tool for clinical decision-making. Expert opinion on pharmacotherapy. 2009 Aug 1;10(11):1793-804.

5.     Zhang W, Doherty M, Peat G, Bierma-Zeinstra MA, Arden NK, Bresnihan B, Herrero-Beaumont G, Kirschner S, Leeb BF, Lohmander LS, Mazières B. EULAR evidence-based recommendations for the diagnosis of knee osteoarthritis. Annals of the rheumatic diseases. 2010 Mar 1;69(3):483-9.

6.     Yilmaz V, Umay E, Gundogdu I, Aras B. The comparison of efficacy of single intraarticular steroid injection versus the combination of genicular nerve block and intraarticular steroid injection in patients with knee osteoarthritis: a randomised study. Musculoskeletal surgery. 2021 Apr;105:89-96.

7.     More SN, Gaikar RR, Shenoy AD, Gupta S, More S, GAIKAR RR. Improvement in pain and quality of life after ultrasound-guided saphenous nerve block in patients with knee osteoarthritis. Cureus. 2022 May 16;14(5):2-9.