Effects of Genicular Nerve Block in Knee Osteoarthritis

NCT03781843 | Unknown

• 1 other identifier: 2018/42
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Genicular nerve block is a safe and effective therapeutic procedure for intractable pain associated with chronic knee osteoarthritis (OA). There is increasing support for the neuropathic component to the knee OA pain. Investigators proposed that targeting treatment to the underlying pain mechanism can improve pain management in knee OA. There is a debate on injectable solutions used in nerve blocks. Investigators aimed to investigate the efficacy of genicular nerve block and to determine which solution should be appropriate for patients with knee osteoarthritis who have neuropathic or nociceptive pain.

Conditions

Knee Osteoarthritis

Keywords

Neuropathic Pain; Nerve block; Knee osteoarthritis

Outcome Measures

Primary Outcomes (2)

• Efficacy of genicular nerve block on neuropathic pain reduction in knee osteoarthritis

  Neuropathic pain reduction is measured by painDETECT questionnaire (PD-Q) which consists of 9 items that evaluate pain quality, pattern and radiation. Possible scores range from -1 to 38, with higher scores indicating more neuropathic-like symptoms. Clinical assessments:score ≤12: unlikely neuropathic pain; score 13-18: possibly neuropathic pain, and score ≥19:likely neuropathic pain.

  3 months

• Efficacy of genicular nerve block on nociceptive pain reduction in knee osteoarthritis.

  Nociceptive pain reduction is measured by Visual analogue scales (VAS). The score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity. Pain intensity as none, mild, moderate, or severe, the following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain (5-44 mm), moderate pain (45-74 mm), and severe pain (75- 100 mm).

  3 months

Secondary Outcomes (2)

• Efficacy of genicular nerve block on physical function in knee osteoarthritis.

  6 months

• Efficacy of genicular nerve block on walking distance in knee osteoarthritis.

  6 months

Study Arms (3)

Genicular nerve block with lidocaine

ACTIVE COMPARATOR

The ultrasound-guided genicular nerve block was performed at the site of the superior lateral, the superior medial, and the inferior medial genicular nerves. Color Doppler was used to identify the arterial structures which serve as landmarks for the corresponding nerves.10 cm 21 G insulated block needle was inserted and aligned with the ultrasound scanning plane. Once satisfactory position of the needle is confirmed, 6 mL of a solution containing 6 mL of 2% lidocaine or 6 mL dextrose or 6 mL saline was slowly injected. Spread of local anesthetic was documented adjacent to the target nerve. This procedure was performed at the site of the three genicular nerves Interventions: Drug: 6 mL 2% lidocaine Procedure: Genicular nerve block

Drug: Genicular nerve block with lidocaine

Genicular nerve block with saline

PLACEBO COMPARATOR

The ultrasound-guided genicular nerve block was performed at the site of the superior lateral, the superior medial, and the inferior medial genicular nerves. Color Doppler was used to identify the arterial structures which serve as landmarks for the corresponding nerves. 10 cm 21 G insulated block needle was inserted and aligned with the ultrasound scanning plane. Once satisfactory position of the needle time is confirmed, 5 mL of a saline was slowly injected. Spread of local anesthetic was documented adjacent to the target nerve. This procedure was performed at the site of the three genicular nerves. Interventions:Drug: Saline Procedure: Genicular nerve block

Drug: Genicular nerve block with saline

Genicular nerve block with dextrose

PLACEBO COMPARATOR

The ultrasound-guided genicular nerve block was performed at the site of the superior lateral, the superior medial, and the inferior medial genicular nerves. Color Doppler was used to identify the arterial structures which serve as landmarks for the corresponding nerves. 10 cm 21 G insulated block needle was inserted and aligned with the ultrasound scanning plane. Once satisfactory position of the needle time is confirmed, 5 mL of a dextrose was slowly injected. Spread of local anesthetic was documented adjacent to the target nerve. This procedure was performed at the site of the three genicular nerves. Interventions:Drug: Dextrose Procedure: Genicular nerve block

Drug: Genicular nerve block with dextrose

Interventions

Genicular nerve block with lidocaine DRUG

The color doppler ultrasound-guided genicular nerve block at the site of the superior lateral, the superior medial, and the inferior medial genicular nerves.

Genicular nerve block with lidocaine

Genicular nerve block with saline DRUG

The color doppler ultrasound-guided genicular nerve block at the site of the superior lateral, the superior medial, and the inferior medial genicular nerves.

Genicular nerve block with saline

Genicular nerve block with dextrose DRUG

The color doppler ultrasound-guided genicular nerve block at the site of the superior lateral, the superior medial, and the inferior medial genicular nerves.

Genicular nerve block with dextrose

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• knee pain for more than 3 month.
• radiological tibiofemoral OA (Kellgren-Lawrence grade 2-4 )

You may not qualify if:

• acute knee pain, prior knee surgery, other connective tissue diseases that affected the knee, serious neurological or psychiatric disorders, steroid or hyaluronic acid injection therapy during the previous 3 months, sciatic pain, patients with polyneuropathy, anticoagulant medication use, pacemaker use, prior electroacupuncture treatment and physical treatment.

Sponsors & Collaborators

• Fatih Sultan Mehmet Training and Research Hospital: lead

Study Sites (1)

Fatih Sultan Mehmet Education and Research Hospital

Istanbul, 34752, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Neuralgia

Interventions

Lidocaine; Sodium Chloride; Glucose

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Hexoses; Monosaccharides; Sugars; Carbohydrates

Study Officials

• Pınar Akpınar, MD

  FATİH SULTAN MEHMET EDUCATION AND RESEARCH HOSPITAL

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 27, 2018
• First Posted: December 20, 2018
• Study Start: September 3, 2018
• Primary Completion: December 31, 2018
• Study Completion: March 29, 2019
• Last Updated: January 22, 2019

Record last verified: 2018-12

Locations

TU (1)