Effects of Genicular Nerve Block in Knee Osteoarthritis

NCT ID: NCT03781843

Last Updated: 2019-01-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-03
• Study Completion Date: 2019-03-29

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.

Detailed Description

The patients who participated in this study were selected from outpatients who attended our hospital for knee pain. These 90 patients were who matched the following criteria. All patients had knee pain for more than 3 months.

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. This method was used to inject a total of 6 mL of lidocaine or 6 mL dextrose or 6 mL saline at 3 separate target sites: the superior lateral, superior medial, and inferior medial genicular nerves.

Pain was evaluated with Analog Analogue Scale (VAS), daily living activities with Western Ontario and McMaster Universities Arthritis Index (WOMAC), maximum distance walked with Lequesne Score, and neuropathic pain was evaluated with painDETECT inquiry form. Outcome measures were assessed at baseline and at 1st, 4th weeks, and 3rd months after the procedure.

Conditions

Knee Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Genicular nerve block with lidocaine

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

Group Type: ACTIVE_COMPARATOR

Genicular nerve block with lidocaine

Intervention Type: 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

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

Group Type: PLACEBO_COMPARATOR

Genicular nerve block with saline

Intervention Type: 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

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

Group Type: PLACEBO_COMPARATOR

Genicular nerve block with dextrose

Intervention Type: 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.

Interventions

Genicular nerve block with lidocaine

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

Intervention Type: DRUG

Genicular nerve block with saline

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

Intervention Type: DRUG

Genicular nerve block with dextrose

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fatih Sultan Mehmet Training and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Berrak Tas

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pınar Akpınar, MD

Role: STUDY_DIRECTOR

FATİH SULTAN MEHMET EDUCATION AND RESEARCH HOSPITAL

Locations

Fatih Sultan Mehmet Education and Research Hospital

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2018/42

Identifier Type: -

Identifier Source: org_study_id