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

NCT07397286 | Active Not Recruiting

• 1 other identifier: 2025/297
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Transforaminal Epidural Injection; Dorsal Root Ganglion Stimulation; Servical Disc Herniation

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

patients to whom applied epidural injection with local anaesthetic

EXPERIMENTAL

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

patients to whom applied epidural injection without local anaesthetic

ACTIVE COMPARATOR

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

Interventions

servical transforaminal epidural steroid injection with local anaesthetic PROCEDURE

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.

patients to whom applied epidural injection with local anaesthetic

servical transforaminal epidural steroid injection without local anaesthetic PROCEDURE

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.

patients to whom applied epidural injection without local anaesthetic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aydin Adnan Menderes University: lead

Study Sites (1)

Adnan Menderes University Efeler / Aydın

Aydin, 09100, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Anesthesia, Local

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Study Record Dates

• First Submitted: February 2, 2026
• First Posted: February 9, 2026
• Study Start: November 19, 2025
• Primary Completion: April 1, 2026
• Study Completion: May 1, 2026
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)