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RecruitingNCT06438952Updated Jun 3, 2024

Efficacy and Duration of Pain Relief in Transforaminal and Lumbar Sympathetic Blocks

An interventional study of Transforaminal steroid injection combined with lumbar sympathetic blockade and Transforaminal steroid injection only in Low Back Pain and Lumbar Disc Herniation, sponsored by Bezmialem Vakif University. Recruiting at 2 sites in Turkey. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-06-03.

Sponsored by Bezmialem Vakif University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Nov 2024, 1 year 11 months ago, but the record still lists the study as recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

Low back pain is a symptom that is frequently seen in the general population and reduces the quality of life of patients. Conventional medical treatment for patients with low back pain includes oral medication, lifestyle modification, education, exercises, lumbar traction and manual manipulation, heat application, and other interventional procedures. Epidural injections, one of the interventional procedures, are one of the common treatment methods for low back pain, especially caused by disc prolapse. Steroids are commonly used to reduce inflammation in the epidural space. Epidural steroid injection can be given to the lumbar epidural space via transforaminal, interlaminar and caudal routes, and the effectiveness rate of each is different. These interventional methods used to treat low back pain can be applied in combination.

The main purpose of this study is to observe how adding lumbar sympathetic blockade will affect the patient's pain in the postoperative period in patients to whom we applied caudal epidural and transforaminal steroid injection.

Read the detailed description

Low back pain is a symptom that is frequently seen in the general population and reduces the quality of life of patients. Conventional medical treatment for patients with low back pain includes oral medication, lifestyle modification, education, exercises, lumbar traction and manual manipulation, heat application, and other interventional procedures [1, 2]. Epidural injections, one of the interventional procedures, are one of the common treatment methods for low back pain, especially caused by disc prolapse. Steroids are widely used to reduce inflammation in the epidural space [3, 4]. Epidural steroid injection can be administered to the lumbar epidural space via transforaminal, interlaminar and caudal routes, and each has different efficacy rates [5-7].

Sympathetically maintained pain, including lumbar sympathetic ganglion block (LSGB), complex regional pain syndrome (CRPS) types I and II, neuropathies (such as postherpetic neuralgia, stump or phantom limb pain), diabetic polyneuropathy, and ischemic pain from vascular insufficiency in the lower leg It is a widely applied procedure for diagnosing and managing diseases [8]. The autonomic nervous system consists of sympathetic and parasympathetic departments. As the name suggests, blood supply to the lower extremity increases after lumbar sympathetic block. This is useful in sympathetic system-mediated treatment of pain [9].

The most important reason for adding fentanyl and magnesium as adjvams is to improve the quality of analgesia and provide analgesia for a longer period of time. Both fentanyl and magnesium have the ability to modulate neurotransmitter release and affect neuronal excitability. Fentanyl demonstrates the role of the sympathetic nervous system in modulating pain by increasing the effectiveness of endogenous opioids in the sympathetic ganglia and central nervous system. Magnesium competes with calcium; It reduces the release of neurotransmitters such as acetylcholine.

Magnesium's ability to inhibit the release of acetylcholine contributes to its anticonvulsant properties. Additionally, blocking NMDA receptors contributes to its analgesic effects. Additionally, magnesium's ability to enhance the effects of local anesthetics has been studied. By increasing the firing threshold in nerves and causing hyperpolarization, magnesium enhances the effect of local anesthetics, thereby improving nerve blockade. This enhancement of nerve blockade is particularly evident when magnesium is added to agents such as bupivacaine [10, 11].

These interventional methods used to treat low back pain can be applied in combination. There is not enough research on this subject.

02

Conditions studied

  • Low Back Pain
  • Lumbar Disc Herniation

Keywords

  • Transforaminal Steroid İnjection
  • Lumbar Sympathetic Blockade
  • Lumbar Disc Herniation
  • Neuropathic Pain Questionnaire
  • Numerical Rating Scale
03

In context

Intervertebral Disc Displacement

478 studies on the registry are indexed under Intervertebral Disc Displacement; 104 are open to participants now.

This study's planned enrollment of 20 is below the median of 63 across 344 interventional studies indexed under Intervertebral Disc Displacement.

Browse Intervertebral Disc Displacement studies →

Lead sponsor

Bezmialem Vakif University is the lead sponsor of 345 studies on the registry; 58 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • ASA I-II-III
  • Patients who underwent facet joint injection and transforaminal injection due to lumbar disc herniation

Exclusion criteria

Exclusion Criteria:

  • Patients with known allergies to the drugs to be used in treatment
  • Infection near the puncture site
  • Known coagulation disorders
  • Patients with internal fixation or severe anatomical variation such as scoliosis and tumor
  • History of sympathetic chemical or thermal neurolysis
  • Alcohol and drug use
  • Disorder of consciousness
  • Liver failure, renal failure, advanced cardiac failure
  • Uncontrolled diabetes mellitus
  • Morbid obesity (body mass index (BMI) > 35 kg m-2)
  • Female patients during pregnancy and breastfeeding
  • Not approving the informed consent form
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
20 participants (estimated)

Study arms

  • Active comparator
    Addition of lumbar sympathetic blockade to transforaminal steroid injection

    The patient will receive both transforaminal steroid injection and lumbar sympathetic blockade.

    Procedure: Transforaminal steroid injection combined with lumbar sympathetic blockade

  • Placebo comparator
    Transforaminal steroid injection only

    The patient will only receive transforaminal steroid injection.

    Procedure: Transforaminal steroid injection only

Interventions

  • ProcedureTransforaminal steroid injection combined with lumbar sympathetic blockade

    Transforaminal steroid injection will be made with 2 mg dexamethason + 20 mg lidocaine + 5mg bupivacaine + 5 mcg fentanyl + 100mg magnesium under US-guidance Lumbar sympathetic blockade will be made with 5 ml 0.5% bupivacaine + 6 mg dexamethason + 10 ml NaCl

  • ProcedureTransforaminal steroid injection only

    Transforaminal steroid injection will be made with 2 mg dexamethason + 20 mg lidocaine + 5mg bupivacaine + 5 mcg fentanyl + 100mg magnesium under US-guidance

06

What researchers measure

Primary outcomes

  1. Pain intensity score

    Postoperative pain assessed with numeric rating scale (NRS 0: no pain 10:pain as bad as can be )

    Time frame: Preoperative and postoperative 24th hour, 1st week, 1st month and 6th month

Secondary outcomes

  1. Oswestry Disability Index (ODI)

    Time frame: Preoperative and postoperative 24th hour, 1st week, 1st month and 6th month

  2. Neuropathic pain questionnaire

    Time frame: Preoperative and postoperative 24th hour, 1st week, 1st month and 6th month

  3. Patient satisfaction

    The patient is asked to give a score between 1 and 10 in terms of satisfaction with the procedure (1 = I am not satisfied with the procedure, 10 = I am very satisfied with the procedure).

    Time frame: Patient satisfaction measured using a numeric rating scale 0 to 10 (0 = unsatisfied; 10 =very satisfied)

07

Study locations

1 of 2 sites recruiting
  • Aylin Ceren Şanlı
    Istanbul, Turkey
    Recruiting
  • Aylin Ceren
    Istanbul, Turkey
    Completed
08

References and documents

Individual participant data

Plan to share: Undecided — yes

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 3, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06438952
Lead sponsor
Bezmialem Vakif University
Responsible party
Sponsor
First posted
Jun 3, 2024
Start date
Jun 2024 (estimated)
Primary completion
Nov 2024 (estimated)
Completion
Dec 2024 (estimated)
Last update
Jun 3, 2024

Study contacts

Zübeyde Özdemir
Contact
etikkurul@bezmialem.edu.tr
+90 2125232288 ext. 3238
Zübeyde Özdemir
study chair · ethics committee chairman

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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