Clinical trial NCT06244667: Comparison of Different Local Anesthetics in Cervical Facet Medial Branch Blockade
Official title: Comparison of Different Local Anesthetics in Cervical Facet Medial Branch Blockade
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Neck
Keywords: pain
nerve block
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2024-02-06
Enrollment: 114
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Neck pain is a common disease in society. In studies, the annual and lifetime prevalence was found to be 37.2% and 48.5%, respectively (1). Neck pain may be axial or radicular. Causes of axial neck pain include cervical strain, discogenic pain, cervical facet pain, spondylosis, whiplash, and myofascial pain. (2) Cervical facet degeneration is a common cause of axial neck pain (3). Pain originating from the cervical facet joint is localized to the midline of the neck and increases with neck extension. (2) Diagnosis is made by physical examination and radiological imaging. The distribution patterns of pain originating from the cervical facet joint vary depending on the level of the joint involved

Detailed description: Neck pain is a common disease in society. Causes of axial neck pain include cervical strain, discogenic pain, cervical facet pain, spondylosis, whiplash, and myofascial pain. Cervical facet degeneration is a common cause of axial neck pain. Pain originating from the cervical facet joint is localized to the midline of the neck and increases with neck extension. Diagnosis is made by physical examination and radiological imaging. The distribution patterns of pain originating from the cervical facet joint vary depending on the level of the joint involved.

Conservative treatment methods for facet joint pain are medical treatment and various physical therapy modalities. Interventional pain treatments are on the agenda for patients who cannot achieve effective pain palliation with conservative treatment. Since facet joints are innervated by the dorsal ramus, medial branch of the spinal nerves, medial branch blockade is applied in the treatment of facet-related pain. In cervical facet medial branch blockade, a mixture of local anesthetic and steroid is injected. Studies have found that adding steroids to local anesthetics increases injection effectiveness. Although there is no consensus on the type of steroid to be used, it is safer to use dexamethasone, a particle-free steroid, considering the dense vascular structure of the cervical region. However, the types of local anesthetic used in cervical facet medial branch blockade vary between studies. The type of local anesthetic used in cervical facet medial branch blockade in our clinic varies. There is only one study in the literature comparing local anesthetic types. Researchers compared the effectiveness of lidocaine and bupivacaine in cervical facet medial branch blockade without adding steroids. Researchers stated that lidocaine has a faster effect and longer duration of effect. Since there is no consensus on the type of local anesthetic, prilocaine or lidocaine is preferred in practice. This study aims to compare the effectiveness of lidocaine and prilocaine added to dexamethasone in cervical facet medial branch blockade, one of the routine treatment methods in our clinic.

Within the scope of the study, patients deemed suitable for cervical facet medial branch injection will be randomly numbered for prilocaine or lidocaine injection through the computer program. 57 patients will receive lidocaine + steroid injection, 57 patients will receive prilocaine + steroid injection. Cervical facet medial branch injections will be administered. The evaluations of the patients before and after the procedure will be recorded by the researcher who is blind to the procedure performed. Demographic information of the patients, including age, gender, comorbidities, pain duration, and facet injection level, will be recorded before the procedure. Before the procedure, pain intensity will be evaluated using the NRS 11 scale, and functionality will be evaluated using the Neck Disability Index (NDI). The amount of medication used by the patients (non-steroidal anti-inflammatory analgesics, opioids, muscle relaxants) will also be noted.

Eligibility criteria: Inclusion Criteria:

* Patients aged 20-79
* A history of axial cervical pain without radicular symptoms for at least 3 months
* NRS score of 4 and above
* Not having had a cervical interventional procedure in the last year
* Patients who cannot achieve adequate pain palliation with pharmacological and physical treatment modalities

Exclusion Criteria:

* Patients experiencing cervical radicular pain due to disc herniation or foraminal stenosis and neck pain due to cervical canal stenosis
* Patients with previous cervical surgery
* Patients with psychiatric illnesses that are unstable/uncontrolled with medical treatment
* Pregnant patients
* Bleeding diathesis
* Patients who received epidural steroid injection within the last year
* Patients with known allergies to the substances administered during the procedure (local anesthetic, steroid, contrast material)
* Patients with cervical spondylosis, radiculopathy, myelopathy, spondylolisthesis, compression fracture, previous discitis, sequestered disc, overt disc herniation

Primary outcomes:
measure: change of pain intensity
timeFrame: 1 month
measure: change of participants functionality
timeFrame: 1 month
measure: participants satisfaction
timeFrame: 1 month
Secondary outcomes:
measure: drug use in groups
timeFrame: 1 month
measure: difference of drug use between groups
timeFrame: 1 month
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara University
Study officials:
affiliation: Ankara University
name: Gungor E Özgencil, Prof
role: STUDY_DIRECTOR
References:
citation: Manchikanti L, Singh V, Falco FJ, Cash KM, Fellows B. Cervical medial branch blocks for chronic cervical facet joint pain: a randomized, double-blind, controlled trial with one-year follow-up. Spine (Phila Pa 1976). 2008 Aug 1;33(17):1813-20. doi: 10.1097/BRS.0b013e31817b8f88.
citation: Manchikanti L, Sanapati MR, Pampati V, Soin A, Atluri S, Kaye AD, Subramanian J, Hirsch JA. Update of Utilization Patterns of Facet Joint Interventions in Managing Spinal Pain from 2000 to 2018 in the US Fee-for-Service Medicare Population. Pain Physician. 2020 Mar;23(2):E133-E149.