Cervical Retrolaminar Block Versus Cervical Epidural Injection for Cervical Radiculopathy

NCT07275320 | Completed

• 1 other identifier: CRLB-ANEST-NA-O1
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Cervical radiculopathy is a common clinical condition, affecting approximately 1 in 1,000 individuals each year, and is typically characterized by neck pain radiating to the upper extremities. Although about 90% of patients respond to conservative treatment, cervical epidural steroid injection is widely used as an interventional alternative to surgery in those with symptoms refractory to conservative management. However, concerns regarding the safety of cervical epidural steroid injection have increased in recent years. Ultrasound-guided cervical retrolaminar block, which does not require entry into the neuraxial space, is considered a theoretically safer technique. In this prospective, randomized study, 70 patients with cervical radiculopathy refractory to conservative treatment were enrolled and randomly assigned to receive either ultrasound-guided cervical retrolaminar block (n = 35) or fluoroscopy-guided cervical epidural steroid injection (n = 35). The study aimed to compare the clinical efficacy and safety of these two interventional approaches.

Conditions

Cervical Radiculopathy

Keywords

Cervical retrolaminar block; Cervical epidural steroid injection; Cervical Radiculopathy

Outcome Measures

Primary Outcomes (1)

• Change in pain intensity assessed by the Visual Analog Scale (VAS)

  Pain intensity will be assessed in both groups using a 10-cm Visual Analog Scale (VAS), where 0 indicates "no pain" and 10 indicates "worst imaginable pain." VAS scores will be recorded before the procedure (baseline) and at 1, 4, 8, and 12 weeks after the intervention. The primary outcome is the change in VAS pain scores from baseline at 1, 4, 8, and 12 weeks and the comparison of these changes between the two treatment groups.

  At baseline and at 1, 4, 8, and 12 weeks after the procedure.

Secondary Outcomes (2)

• Change in Neck Disability Index (NDI) score

  At baseline and at 1, 4, 8, and 12 weeks after the procedure.

• Incidence of treatment-related adverse events in both groups

  Day of the procedure (baseline) to 12 weeks after the intervention

Study Arms (2)

GRUP 1: Fluoroscopy-guided cervical interlaminar epidural Injection

ACTIVE COMPARATOR

Participants in Group 1 are treated with a fluoroscopy-guided cervical interlaminar epidural injection consisting of 8 mL of a solution containing 0.25% bupivacaine and 8 mg dexamethasone.

Procedure: Fluoroscopy-guided cervical interlaminar epidural injection; Drug: Bupivacaine 0.25%; Drug: Dexamethasone

Group 2 - Ultrasound-guided cervical retrolaminar block

ACTIVE COMPARATOR

Participants in Group 2 are treated with an ultrasound-guided cervical retrolaminar block using a solution containing 0.25% bupivacaine and 8 mg dexamethasone. The injectate is administered either unilaterally with 4 mL or bilaterally with a total of 8 mL, depending on the patient's symptoms.

Procedure: Cervical Retrolaminar Block; Drug: Bupivacaine 0.25%; Drug: Dexamethasone

Interventions

Fluoroscopy-guided cervical interlaminar epidural injection PROCEDURE

A fluoroscopy-guided cervical interlaminar epidural injection was performed as a non-surgical treatment option for cervical radiculopathy. Under C-arm fluoroscopic guidance, the C7-T1 intervertebral space was identified. An 18-gauge Tuohy needle was advanced into the epidural space via a medial approach using the hanging drop technique. After confirming epidural spread with the injection of 1 mL of non-ionic contrast solution, an epidural injection was performed with a total of 8 mL of solution containing 0.25% bupivacaine and 8 mg dexamethasone.

GRUP 1: Fluoroscopy-guided cervical interlaminar epidural Injection

Cervical Retrolaminar Block PROCEDURE

patients who received a cervical retrolaminar block were administered a solution containing 0.25% bupivacaine and 8 mg dexamethasone under ultrasound guidance. The injectate was applied unilaterally with 4 mL or bilaterally with a total of 8 mL, depending on the patient's symptoms

Group 2 - Ultrasound-guided cervical retrolaminar block

Bupivacaine 0.25% DRUG

Bupivacaine 0.25% solution is used as the local anesthetic component of both the fluoroscopy-guided cervical interlaminar epidural injection and the ultrasound-guided cervical retrolaminar block.

GRUP 1: Fluoroscopy-guided cervical interlaminar epidural Injection; Group 2 - Ultrasound-guided cervical retrolaminar block

Dexamethasone DRUG

Dexamethasone 8 mg is used as the corticosteroid component of both the fluoroscopy-guided cervical interlaminar epidural injection and the ultrasound-guided cervical retrolaminar block.

GRUP 1: Fluoroscopy-guided cervical interlaminar epidural Injection; Group 2 - Ultrasound-guided cervical retrolaminar block

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a diagnosis of cervical radiculopathy confirmed by magnetic resonance imaging (MRI).
• Visual Analog Scale (VAS) pain score ≥ 5 and an elevated Neck Disability Index (NDI) score.
• Age between 18 and 80 years.
• Patients without motor weakness or clinical signs of myelopathy.
• Patients who did not respond to conservative treatments such as analgesics, physical therapy, or traction.

You may not qualify if:

• Patients who do not provide informed consent or who have coagulopathy.
• Patients with a known allergy to the study medications, organ failure, pregnancy, or lactation.
• Patients with infection in the cervical spine or surrounding tissues, or those with rheumatologic, neurologic, or neuromuscular diseases.
• Patients with a history of cervical spine surgery or with shoulder/peripheral nerve pathology that may confound the diagnosis.
• Patients using neuropathic pain medications (such as pregabalin or gabapentin) or those with a cardiac pacemaker.

Sponsors & Collaborators

• Istanbul Medeniyet University: lead

Study Sites (1)

Goztepe Suleyman Yalcin City Hospital, Department of Anesthesiology and Reanimation, Interventional Pain Management Unit

Istanbul, Kadikoy, Istanbul, 34722, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Radiculopathy

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• MAHMUT DURMUS, Prof. Dr., MD

  Department of Anesthesiology and Reanimation, Interventional Pain (Algology) Unit, Göztepe Prof. Dr. Süleyman Yalçın City Hospital, Istanbul Medeniyet University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The clinician responsible for follow-up visits and outcome assessments (VAS and NDI) was blinded to the type of block performed in order to ensure objective evaluation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist, Department of Anesthesiology and Reanimation, Istanbul Medeniyet University; Principal Investigator

Model Details: This study was conducted using a parallel assignment design. A total of 70 patients with cervical radiculopathy unresponsive to conservative management were randomized in a 1:1 ratio to two groups using a sealed-envelope method. Group 1 was assigned to receive fluoroscopy-guided cervical epidural injection (ESI), and Group 2 was assigned to receive ultrasound-guided cervical retrolaminar block (CRLB). All participants were prospectively followed for 12 weeks.

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: December 10, 2025
• Study Start: December 5, 2024
• Primary Completion: March 30, 2025
• Study Completion: July 30, 2025
• Last Updated: December 11, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)