Comparison of Different Local Anesthetics in Cervical Facet Medial Branch Blockade

NCT06244667 | Completed

• 1 other identifier: 2023/468
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

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

Conditions

Pain, Neck

Keywords

pain; nerve block

Outcome Measures

Primary Outcomes (3)

• change of pain intensity

  Change from baseline in pain scores on the Numeric Rating Scale at 1 month in both groups

  1 month

• change of participants functionality

  Change of participants functionality (Neck Disability Score) at 1 month in both groups

  1 month

• participants satisfaction

  Participants satistification degree (satisfied", "uncertain" or "dissatisfied") at 1 month in both groups

  1 month

Secondary Outcomes (2)

• drug use in groups

  1 month

• difference of drug use between groups

  1 month

Study Arms (2)

cervical faset median block with lidocaine

ACTIVE COMPARATOR

cervical faset median block with lidocaine

Procedure: facet median block with lidocaine

cervical faset median block with prilocaine

ACTIVE COMPARATOR

cervical faset median block with prilocaine

Procedure: facet median block with prilocain

Interventions

facet median block with prilocain PROCEDURE

facet median block with prilocain

cervical faset median block with prilocaine

facet median block with lidocaine PROCEDURE

facet median block with lidocaine

cervical faset median block with lidocaine

Eligibility Criteria

• Age: 20 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara University: lead

Study Sites (1)

Ankara University

Ankara, 06230, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 18670333 BACKGROUND

• 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.

  PMID: 32214289 BACKGROUND

MeSH Terms

Conditions

Neck Pain; Pain

Interventions

Prilocaine; Lidocaine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Acetanilides

Study Officials

• Gungor E Özgencil, Prof

  Ankara University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: January 20, 2024
• First Posted: February 6, 2024
• Study Start: October 1, 2023
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: February 6, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)