Clinical trial NCT06438952: Efficacy and Duration of Pain Relief in Transforaminal and Lumbar Sympathetic Blocks
Official title: Efficacy and Duration of Pain Relief in Transforaminal and Lumbar Sympathetic Blocks
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Low Back Pain
Lumbar Disc Herniation
Keywords: Transforaminal Steroid İnjection
Lumbar Sympathetic Blockade
Lumbar Disc Herniation
Neuropathic Pain Questionnaire
Numerical Rating Scale
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2024-06-03
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain intensity score
timeFrame: Preoperative and postoperative 24th hour, 1st week, 1st month and 6th month
Secondary outcomes:
measure: Oswestry Disability Index (ODI)
timeFrame: Preoperative and postoperative 24th hour, 1st week, 1st month and 6th month
measure: Neuropathic pain questionnaire
timeFrame: Preoperative and postoperative 24th hour, 1st week, 1st month and 6th month
measure: Patient satisfaction
timeFrame: Patient satisfaction measured using a numeric rating scale 0 to 10 (0 = unsatisfied; 10 =very satisfied)
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Aylin Ceren Şanlı
city: Istanbul
country: Turkey
facility: Aylin Ceren
Study officials:
affiliation: ethics committee chairman
name: Zübeyde Özdemir
role: STUDY_CHAIR
References: