Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06438952 |
| Other study ID # |
E.142568 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 2024 |
| Est. completion date |
December 2024 |
Study information
| Verified date |
May 2024 |
| Source |
Bezmialem Vakif University |
| Contact |
Zübeyde Özdemir |
| Phone |
+90 2125232288 |
| Email |
etikkurul[@]bezmialem.edu.tr |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
