The Effect of Adding a Local Anesthetic to Transforaminal Epidural Injection in Cervical Disc Herniation.

Comparison of the Efficacy of Combined Dorsal Root Ganglion Pulsed Radiofrequency and Cervical Transforaminal Epidural Steroid Injection With and Without Local Anesthetic in Cervical Disc Herniation, Prospective Controlled Study

The study is designed as a double-blind, prospective, randomized controlled trial. Blindness is ensured by having different researchers performing the interventional procedures and monitoring the pain diaries, thus preventing them from knowing which procedure is performed on which patient. Patient randomization will be performed using computer assistance.

After obtaining approval from the hospital ethics committee, clinical trials will be initiated. Patients who present to the Department of Neurology, Algology Division, ADÜTF between 2025-2026 and undergo DRG-PRF and TFAESI for radicular pain due to cervical disc herniation will be divided into two groups. Patients in Group 1 will undergo DRG-PRF and TFAESI with the addition of local anesthetic. Patients in Group 2 will undergo DRG-PRF and TFAESI without the addition of local anesthetic. During the study, NRS score measurements will be taken to assess pain intensity in patients in both Group 1 and Group 2 before the procedure and at 1, 3, and 6 months post-procedure follow-ups. Neurological and musculoskeletal examinations will be performed during routine check-ups before the procedure and at 1, 3, and 6 months after the procedure, and any developing side effects will be recorded.

Study Overview

• Status: Active, not recruiting
• Conditions: Dorsal Root Ganglion Stimulation; Transforaminal Epidural Injection; Servical Disc Herniation
• Intervention / Treatment: Procedure: servical transforaminal epidural steroid injection with local anaesthetic; Procedure: servical transforaminal epidural steroid injection without local anaesthetic

Detailed Description

The interventional treatment procedure is performed in the operating room under sterile conditions, in the supine position, using a C-arm fluoroscopy device. The first intervertebral foramen visible under fluoroscopy is C2-C3. Once the appropriate cervical space is identified, the C-arm fluoroscopy device is directed obliquely to 45-65 degrees until the cervical neural foramen is visualized as a circle. The cannula insertion site is determined. The skin and subcutaneous tissue are anesthetized with 2% lidocaine. A 5 cm long RF cannula with a 5 mm active tip is advanced towards the 6 o'clock position of the neural foramina. The needle is advanced until it contacts the superior facet joint, then guided into the foramen. After entering the foramen, to avoid direct intrathecal or spinal cord damage, the needle is advanced to the facet column and into the epidural space while anteroposterior views are obtained with fluoroscopy. Approximately 0.5 mL of non-ionizing contrast agent is injected to confirm needle placement. The spread of radiopaque material, which adheres to the periradicular membrane, is observed both within the foramen and around the nerve root during fluoroscopy. If abnormal sensation, vibration, or pain is observed with a stimulus less than 0.7 Volts for sensory stimulation, or if a pulse is felt in the arm with a stimulus less than 2.0 Volts for motor stimulation, it is assumed that the catheter needle has been placed near the dorsal root ganglion. Subsequently, patients in Group 1 are given 4 mg dexamethasone + 20 mg lidocaine, and patients in Group 2 are given 4 mg dexamethasone. The radiofrequency generator is adjusted so that the temperature of the catheter needle tip does not exceed 42 ºC, and it is subjected to pulsed radiofrequency treatment for 4 minutes. Patient response will be determined based on the reduction in pain at follow-up examinations at 1, 3, and 6 months after the procedure as follows: good response > 50% reduction, poor response < 50% reduction, or no change, no response.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Aydin, Turkey (Türkiye), 09100
    • Adnan Menderes University Efeler / Aydın

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Patients consisted of those who presented to our outpatient clinic with neck and arm pain, who had received medical and/or physical therapy but whose symptoms did not improve.

Exclusion Criteria:

• The procedure was not performed on those with neurological deficits requiring surgery, those with known allergies to lidocaine and dexamethasone, those who had recently undergone head and neck surgery, diabetic patients with impaired blood sugar regulation, those who had received epidural steroid injections or depot steroids within the last 15 days, those with progressive neurological deficits, those with coagulation disorders (INR > 1.5; platelets < 100,000/mm³), those with any lesion or infection in the cervical region that would prevent epidural intervention, and pregnant women.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: patients to whom applied epidural injection with local anaesthetic; Patients in Group 1 are given 4 mg of dexamethasone + 20 mg of lidocaine. The radiofrequency generator is adjusted so that the catheter needle tip temperature does not exceed 42 ºC, and they undergo pulsed radiofrequency treatment for 4 minutes	Procedure: servical transforaminal epidural steroid injection with local anaesthetic; The interventional treatment procedure is performed in the operating room under sterile conditions, in the supine position, using a C-arm fluoroscopy device.Subsequently, patients in Group 1 receive 4 mg dexamethasone and 1cc lidocain. The radiofrequency generator is adjusted so that the temperature of the catheter needle tip does not exceed 42 ºC.
Active Comparator: patients to whom applied epidural injection without local anaesthetic; Patients in Group 2 are given 4 mg of dexamethasone. The radiofrequency generator is adjusted so that the catheter needle tip temperature does not exceed 42 ºC, and they undergo pulsed radiofrequency treatment for 4 minutes.	Procedure: servical transforaminal epidural steroid injection without local anaesthetic; The interventional treatment procedure is performed in the operating room under sterile conditions, in the supine position, using a C-arm fluoroscopy device.Subsequently, patients in Group 2 receive 4 mg dexamethasone. The radiofrequency generator is adjusted so that the temperature of the catheter needle tip does not exceed 42 ºC.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To compare whether the addition of a local anesthetic to combined DRG-pulsed RF and transforaminal anterior epidural steroid injection (TAESI) treatment makes a difference in clinical efficacy in patients with cervical disc herniation	In patients with radicular neck pain due to cervical disc herniation, the clinical efficacy of adding a local anesthetic during combined DRG-pulsed RF and transforaminal anterior epidural steroid injection (TAESI) was evaluated using the NRS (Numerical Rating Scale) to assess pain control.	6 months

Collaborators and Investigators

• Sponsor: Aydin Adnan Menderes University

Study record dates

Study Major Dates

• Study Start (Actual): November 19, 2025
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: February 2, 2026
• First Submitted That Met QC Criteria: February 2, 2026
• First Posted (Actual): February 9, 2026

Study Record Updates

• Last Update Posted (Actual): February 9, 2026
• Last Update Submitted That Met QC Criteria: February 2, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Anesthesia and Analgesia; Anesthesia, Conduction; Anesthesia; Anesthesia, Local
• Other Study ID Numbers: 2025/297

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No