Clinical trial NCT04215757: Low Dose Lignocaine Injections as a Treatment Option for Acute Lumbosacral Radiculopathy
Official title: PERIPHERAL NERVE BLOCKS WITH LOW DOSE LIGNOCAINE FOR THE TREATMENT OF ACUTE LUMBOSACRAL RADICULOPATHY
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain, Acute
Lead sponsor: All India Institute of Medical Sciences, Rishikesh
Sponsor class: OTHER_GOV
First posted: 2020-01-02
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Low back pain is one of the most common ailments that plagues patients, with nearly 80% of the population developing some form of back pain in their lifetime. Up regulated sodium channels in the nerve root or dorsal root ganglion are the basic cause for the mechano-sensitization and injecting the drug in the peripheral end of the nerve will block these sodium channels, since functionally both ends of the pseudo unipolar neuron are the same.

Detailed description: Low back pain is one of the most common ailments that plague patients, with nearly 80% of the population developing some form of back pain in their lifetime. Of all the causes of low back pain, the most common is lumbar radicular pain which may result from irritation of the nerve fibers or dorsal root ganglia due to intervertebral disc prolapse, degenerative spondylolisthesis or spinal canal stenosis. \[1\] Up regulated sodium channels in the nerve root or dorsal root ganglion are the basic cause for the mechano-sensitization and injecting the drug in the peripheral end of the nerve will block these sodium channels, since functionally both ends of the pseudo unipolar neuron are the same. \[2\]There have yet been no studies done to prove the efficacy of peripheral nerve block as an alternative to lumbar epidurals. We would like to share our experience of peripheral nerve blocks with low dose local Anaesthetics as the treatment of acute lumbosacral radiculopathy.

Eligibility criteria: Inclusion Criteria:

* Age between 18 years to 60 years
* Pain involving up to two segmental levels (L4, L5 and S1).
* Average pain score of ≥5 on an 11-point NRS.
* Tenderness over the concordant peripheral nerves (Gore sign +)
* Computed tomography/Magnetic resonance imaging evidence of nerve root pain concordant with the side and level of clinical features.

Exclusion Criteria:

* Coagulopathy and/or patients on anticoagulants.
* Infection at the site of injection.
* Hypersensitivity to a local anaesthetic agent.
* Evidence of significant sensory or progressive motor deficit.
* Presence of cancer as a cause of back pain.
* History of previous backs surgery/epidural steroid injection.

Primary outcomes:
measure: ≥50% or ≥4 point reduction in an 10-point numeric scale (NRS) at, 1 month, 2 months and 3 months.
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rishikesh
country: India
facility: AIIMS
state: Uttarakhand
Study officials:
affiliation: AIIMS Rishikesh
name: Vijay Adabala, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Levinson SR, Luo S, Henry MA. The role of sodium channels in chronic pain. Muscle Nerve. 2012 Aug;46(2):155-65. doi: 10.1002/mus.23314.