Ultrasound-guided Genicular Nerve Block With Phenol for the Treatment of Chronic Pain Due to Knee Osteoarthritis

NCT ID: NCT03601533

Last Updated: 2018-07-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-05
• Study Completion Date: 2018-11-01

Brief Summary

Osteoarthritis (OA) is one of the most frequent causes of chronic pain, often intense, debilitating and responsible for a large percentage of the elderly. The disease affects about 10% of adults and the knees are the most affected joints. The diagnosis of OA in the knee is predominantly clinical, and can be confirmed by radiological examination. Systemic drugs are indicated before invasive procedures, but pharmacological therapies may offer limited benefits. Thermal radiofrequency lesions of genicular nerves has been used to relieve chronic knee pain, as adjuvant therapy, but with high costs and low availability in the public system. The use of phenol for peripheral analgesic blocks has emerged as a good option and at low cost and can be used in any service of Pain Treatment. The aim of the study is to evaluate the efficacy of 6% phenol for ultrasound-guided genicular nerves neurolysis for the treatment of patients with chronic knee pain due to osteoarthritis.

METHODS: A prospective study will be carried out with 15 patients with chronic pain (more than 4 months) and diagnosis of arthrosis by imaging, with pain intensity greater than 4 (from zero to 10) that will be submitted to ultrasound-guided genicular nerves block. The test block will be performed with 0.25% -1,5 mL bupivacaine on each nerve. Patients who present pain improvement> 50% will undergo neurolysis of genicular nerves with 1,5 mL of 7% phenol in each of the genicular nerves. After the procedure, the patients will be evaluated for 3 months in relation to the intensity of pain at rest and movement and duration of analgesia provided by the intervention, range of movements and functionality of the knee joint.

Conditions

Osteoarthritis, Knee; Chronic Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Phenol

Patients will undergo neurolysis of genicular nerves with 1,5 mL of 7% phenol in each of the genicular nerves (superior, medial and lateral).

Group Type: OTHER

Phenol

Intervention Type: DRUG

1,5 mL of 7% phenol will be injected in each of genicular nerves (superior, medial and lateral).

Interventions

Phenol

1,5 mL of 7% phenol will be injected in each of genicular nerves (superior, medial and lateral).

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Signature of the free, informed consent form
• Age over 18 years old
• Knee pain for more than six months without improvement with clinical treatment
• Clinical and imaging diagnosis (radiography) of knee osteoarthritis
• Moderate pain intensity (pain greater than 4, by the numerical scale).

Exclusion Criteria

• Cognitive impairment or psychiatric disease
• Other causes of knee pain (trauma, complex regional pain syndrome)
• Puncture site infection
• Coagulopathy or use of anticoagulant.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federal University of São Paulo

OTHER

Sponsor Role: lead

Responsible Party

Leonardo Henrique Cunha Ferraro

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Leonardo HC Ferraro, PhD

Role: STUDY_CHAIR

Federal University of São Paulo

Locations

Federal University of Sao Paulo

São Paulo, , Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Leonardo HC Ferraro, PhD

Role: CONTACT

leohcferraro1@hotmail.com

+551155764069

Facility Contacts

Leonardo HC Ferraro, PhD

Role: primary

leohcferraro1@hotmail.com

+551155764069

References

Wong J, Bremer N, Weyker PD, Webb CA. Ultrasound-Guided Genicular Nerve Thermal Radiofrequency Ablation for Chronic Knee Pain. Case Rep Anesthesiol. 2016;2016:8292450. doi: 10.1155/2016/8292450. Epub 2016 Oct 16.

Reference Type: RESULT

PMID: 27822391 (View on PubMed)

Bijlsma JW, Berenbaum F, Lafeber FP. Osteoarthritis: an update with relevance for clinical practice. Lancet. 2011 Jun 18;377(9783):2115-26. doi: 10.1016/S0140-6736(11)60243-2.

Reference Type: RESULT

PMID: 21684382 (View on PubMed)

Choi WJ, Hwang SJ, Song JG, Leem JG, Kang YU, Park PH, Shin JW. Radiofrequency treatment relieves chronic knee osteoarthritis pain: a double-blind randomized controlled trial. Pain. 2011 Mar;152(3):481-487. doi: 10.1016/j.pain.2010.09.029. Epub 2010 Nov 4.

Reference Type: RESULT

PMID: 21055873 (View on PubMed)

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Reference Type: RESULT

PMID: 15135143 (View on PubMed)

Yasar E, Kesikburun S, Kilic C, Guzelkucuk U, Yazar F, Tan AK. Accuracy of Ultrasound-Guided Genicular Nerve Block: A Cadaveric Study. Pain Physician. 2015 Sep-Oct;18(5):E899-904.

Reference Type: RESULT

PMID: 26431143 (View on PubMed)

Gebhardt R, Wu K. Transversus abdominis plane neurolysis with phenol in abdominal wall cancer pain palliation. Pain Physician. 2013 May-Jun;16(3):E325-30.

Reference Type: RESULT

PMID: 23703432 (View on PubMed)

Koyyalagunta D, Engle MP, Yu J, Feng L, Novy DM. The Effectiveness of Alcohol Versus Phenol Based Splanchnic Nerve Neurolysis for the Treatment of Intra-Abdominal Cancer Pain. Pain Physician. 2016 May;19(4):281-92.

Reference Type: RESULT

PMID: 27228515 (View on PubMed)

Zhang Y, Jordan JM. Epidemiology of osteoarthritis. Clin Geriatr Med. 2010 Aug;26(3):355-69. doi: 10.1016/j.cger.2010.03.001.

Reference Type: RESULT

PMID: 20699159 (View on PubMed)

Other Identifiers

Phenol

Identifier Type: -

Identifier Source: org_study_id