Phenol Neurolysis Versus Local Anesthetic Plus Steroid Genicular Nerve Block in Knee Osteoarthritis

NCT ID: NCT07267039

Last Updated: 2025-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

42 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-05-01

Study Completion Date

2026-01-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study aims to evaluate two different ultrasound-guided procedures for patients with knee osteoarthritis (gonarthrosis) who did not benefit from conservative treatments. The first method is genicular nerve neurolysis with phenol, a chemical agent that blocks nerve signals and may reduce pain for a longer period. The second method is a genicular nerve block with local anesthetic (bupivacaine) and corticosteroid (triamcinolone acetonide), which is commonly used to relieve pain and inflammation.

A total of 42 patients are followed prospectively. Pain intensity is measured using the Visual Analog Scale (VAS), and functional outcomes are assessed with the WOMAC Index and Oxford Knee Score (OKS). Joint range of motion, need for pain medications, and possible side effects are also monitored.

The results will help to compare the effectiveness and safety of phenol neurolysis and triamcinolone acetonide-local anesthetic nerve block, and may guide future treatment choices for patients with knee osteoarthritis.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Knee osteoarthritis (gonarthrosis) is a major cause of chronic pain and disability. Patients who fail to respond to conservative treatments such as medications, physical therapy, and exercise often require interventional options for pain relief.

This prospective observational cohort study compares two ultrasound-guided procedures targeting the genicular nerves of the knee:

Genicular nerve neurolysis with phenol - phenol induces protein denaturation and Wallerian degeneration in nerve fibers, providing long-term analgesia.

Genicular nerve block with local anesthetic (bupivacaine) and corticosteroid (triamcinolone acetonide) - this combination offers immediate pain reduction from nerve blockade and potential prolonged relief due to the anti-inflammatory action of the steroid.

A total of 42 patients with Kellgren-Lawrence grade 3-4 knee osteoarthritis and moderate-to-severe pain (VAS ≥ 4 for ≥ 3 months) are prospectively followed. Interventions are performed under ultrasound guidance at the superomedial, superolateral, and inferomedial genicular nerves.

The primary outcome is change in pain severity (VAS). Secondary outcomes include functional improvement assessed by the WOMAC Index and Oxford Knee Score (OKS), joint range of motion, need for nonsteroidal anti-inflammatory drugs (NSAIDs), and procedure-related adverse events. Assessments are performed at baseline, 2 weeks, and 3 months post-procedure.

The study aims to provide comparative evidence on the effectiveness and safety of phenol neurolysis versus triamcinolone acetonide-local anesthetic block, helping to guide clinical practice in the management of knee osteoarthritis.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Knee Osteoarthritis Genicular Nerve Block

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Phenol Neurolysis

Patients in this group receive ultrasound-guided genicular nerve neurolysis. Using a 22G, 50 mm needle under ultrasound guidance, injections are performed at the superomedial, superolateral, and inferomedial genicular nerves. At each site, 2 mL of 6% phenol is injected to achieve chemical neurolysis and long-term pain relief.

Phenol Injection

Intervention Type DRUG

Ultrasound-guided genicular nerve neurolysis performed at the superomedial, superolateral, and inferomedial genicular nerves. A 22G, 50 mm insulated needle is placed under ultrasound guidance, and 2 mL of 6% phenol is injected at each target site for chemical neurolysis.

Local Anesthetic + Triamcinolone Acetonide Block

Patients in this group receive ultrasound-guided genicular nerve block. At the same three target nerves (superomedial, superolateral, inferomedial), 2 mL of a mixture containing 0.25% bupivacaine and 20 mg triamcinolone acetonide is injected at each site. This combination provides nerve blockade with additional anti-inflammatory effect from the corticosteroid.

Bupivacaine + Triamcinolone Acetonide Injection

Intervention Type DRUG

Ultrasound-guided genicular nerve block performed at the superomedial, superolateral, and inferomedial genicular nerves. At each site, 2 mL of a solution containing 0.25% bupivacaine and 20 mg triamcinolone acetonide is injected using a 22G, 50 mm insulated needle. This provides both local anesthetic and anti-inflammatory effects.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Phenol Injection

Ultrasound-guided genicular nerve neurolysis performed at the superomedial, superolateral, and inferomedial genicular nerves. A 22G, 50 mm insulated needle is placed under ultrasound guidance, and 2 mL of 6% phenol is injected at each target site for chemical neurolysis.

Intervention Type DRUG

Bupivacaine + Triamcinolone Acetonide Injection

Ultrasound-guided genicular nerve block performed at the superomedial, superolateral, and inferomedial genicular nerves. At each site, 2 mL of a solution containing 0.25% bupivacaine and 20 mg triamcinolone acetonide is injected using a 22G, 50 mm insulated needle. This provides both local anesthetic and anti-inflammatory effects.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Phenol Neurolysis Local Anesthetic + Steroid Block

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age ≥ 40 years
* Diagnosis of knee osteoarthritis (Kellgren-Lawrence grade 3-4) confirmed by radiographic evaluation
* Moderate to severe knee pain for at least 3 months (VAS ≥ 4)
* Inadequate response to conservative treatments (e.g., medications, physical therapy, exercise)
* Ability to provide informed consent

Exclusion Criteria

* History of knee surgery (e.g., total knee arthroplasty) on the affected side
* Intra-articular injection (hyaluronic acid, corticosteroid, PRP, etc.) within the last 6 months
* Secondary arthritis (e.g., rheumatoid arthritis, gout, septic arthritis, trauma-related arthritis)
* Severe coagulopathy or current use of anticoagulant therapy contraindicating injection
* Local skin infection at the injection site
* Known allergy or contraindication to phenol, bupivacaine, or triamcinolone acetonide
* Severe uncontrolled systemic disease (e.g., advanced cardiac, hepatic, or renal failure)
* Pregnancy or breastfeeding
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Salim Sencar

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Salim Sencar

Resident Physician (Research Assistant), Department of Physical Medicine and Rehabilitation, Ondokuz Mayıs University Faculty of Medicine

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Bora UZUNER, MD (Medical Doctor)

Role: PRINCIPAL_INVESTIGATOR

Ondokuz Mayis University, Faculty of Medicine, Department of Physical Medicine and Rehabilitation

Salim SENCAR, MD (Medical Doctor)

Role: STUDY_DIRECTOR

Ondokuz Mayis University, Faculty of Medicine, Department of Physical Medicine and Rehabilitation

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ondokuz Mayis University, Faculty of Medicine, Department of Physical Medicine and Rehabilitation

Samsun, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

References

Explore related publications, articles, or registry entries linked to this study.

Risso RC, Ferraro LHC, Nouer Frederico T, Peng PWH, Luzo MV, Debieux P, Sakata RK. Chemical Ablation of Genicular Nerve with Phenol for Pain Relief in Patients with Knee Osteoarthritis: A Prospective Study. Pain Pract. 2021 Apr;21(4):438-444. doi: 10.1111/papr.12972. Epub 2020 Dec 29.

Reference Type RESULT
PMID: 33277760 (View on PubMed)

Shanahan EM, Robinson L, Lyne S, Woodman R, Cai F, Dissanayake K, Paddick K, Cheung G, Voyvodic F. Genicular Nerve Block for Pain Management in Patients With Knee Osteoarthritis: A Randomized Placebo-Controlled Trial. Arthritis Rheumatol. 2023 Feb;75(2):201-209. doi: 10.1002/art.42384. Epub 2022 Nov 11.

Reference Type RESULT
PMID: 36369781 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

https://rheumatology.org

American College of Rheumatology (ACR) Guideline for the Management of Osteoarthritis of the Knee

https://www.nice.org.uk/guidance/cg177

National Institute for Health and Care Excellence (NICE) Guideline for Osteoarthritis: Care and Management

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

OMU-EC-2025-44

Identifier Type: OTHER

Identifier Source: secondary_id

OMU-FTR-2025/44

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.