The Effect of Adding a Local Anesthetic to Transforaminal Epidural Injection in Cervical Disc Herniation.
NCT07397286 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2026-02-09
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
Interventions
- 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.
- 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.
Sponsors & Collaborators
-
Aydin Adnan Menderes University
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-11-19
- Primary Completion
- 2026-04-30
- Completion
- 2026-05-31
Countries
- Turkey (Türkiye)
Study Locations
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