Low Dose Lignocaine Injections as a Treatment Option for Acute Lumbosacral Radiculopathy

Not Applicable

• Conditions: Pain, Acute
• Interventions: Procedure: peripheral nerve block

• Registration Number: NCT04215757
• Lead Sponsor: All India Institute of Medical Sciences, Rishikesh

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.

Study Timeline

• Study Start: 2019-01-20
• Status Verified: 2019-12
• Study First Submitted: 2019-12-30
• Study First Submitted QC: 2019-12-30
• Last Update Submitted: 2019-12-30
• Study First Posted: 2020-01-02
• Last Update Posted: 2020-01-02
• Primary Completion: 2020-01-15
• Study Completion: 2020-01-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	peripheral nerve block	Patient received one or two peripheral nerve blocks at a maximum according to their involvement in the operation theatre, with full ASA monitoring under all aseptic precautions. For L4 radiculopathy Saphenous nerve block with 1.5ml of 2% lignocaine diluted to 10ml (0.3%) For L5 radiculopathy Deep peroneal nerve block/posterior tibial nerve block with 1.5ml of 2% lignocaine diluted to 10ml (0.3%) For S1 radiculopathy Sural nerve block with 1.5ml of 2% lignocaine diluted to 10ml (0.3%)
Control group	peripheral nerve block	Patients received one or two peripheral nerve blocks at a maximum according to their involvement in the operation theatre, with full ASA monitoring under all aseptic precautions. For L4 radiculopathy Saphenous nerve block with 10ml distilled water For L5 radiculopathy Deep peroneal nerve block/posterior tibial nerve block with 10ml distilled water For S1 radiculopathy Sural nerve block with10ml distilled water

Primary Outcome Measures

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

Trial Locations

Locations (1)

AIIMS; 🇮🇳 Rishikesh, Uttarakhand, India