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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-30

Study Completion Date

2024-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Low Back Pain Lumbar Disc Herniation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Addition of lumbar sympathetic blockade to transforaminal steroid injection

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

Group Type ACTIVE_COMPARATOR

Transforaminal steroid injection combined with lumbar sympathetic blockade

Intervention Type PROCEDURE

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

Transforaminal steroid injection only

The patient will only receive transforaminal steroid injection.

Group Type PLACEBO_COMPARATOR

Transforaminal steroid injection only

Intervention Type PROCEDURE

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

Interventions

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Transforaminal 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

Intervention Type PROCEDURE

Transforaminal 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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No