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Clinical Trials/NCT04215757
NCT04215757
Unknown
N/A

PERIPHERAL NERVE BLOCKS WITH LOW DOSE LIGNOCAINE FOR THE TREATMENT OF ACUTE LUMBOSACRAL RADICULOPATHY

All India Institute of Medical Sciences, Rishikesh1 site in 1 country60 target enrollmentJanuary 20, 2019
ConditionsPain, Acute

Overview

Phase
N/A
Intervention
Not specified
Conditions
Pain, Acute
Sponsor
All India Institute of Medical Sciences, Rishikesh
Enrollment
60
Locations
1
Primary Endpoint
≥50% or ≥4 point reduction in an 10-point numeric scale (NRS) at, 1 month, 2 months and 3 months.
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 20, 2019
End Date
January 30, 2020
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

ADABALA VIJAY BABU

Principal Investigator

All India Institute of Medical Sciences, Rishikesh

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.

Outcomes

Primary Outcomes

≥50% or ≥4 point reduction in an 10-point numeric scale (NRS) at, 1 month, 2 months and 3 months.

Time Frame: 3 months

change in pain intensity measured with numeric scale.Numerical Pain Rating Scale (NPRS) is a subjective measure in which individuals rate their pain on an ten-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain).

Study Sites (1)

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