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

Pain, Acute Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04215757
• Other study ID #: 13
• Status: Recruiting
• Phase: N/A
• Start date: January 20, 2019
• Est. completion date: January 30, 2020

Study information

• Verified date: December 2019
• Source: All India Institute of Medical Sciences, Rishikesh
• Contact: AJIT KUMAR, MD
• Phone: 9910789377
• Email: ajitdr.ajit[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 30, 2020
• Est. primary completion date: January 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Pain
• Pain, Acute
• Radiculopathy

Intervention

Procedure:
• peripheral nerve block
peripheral nerve blocks with low dose lignocaine in acute radiculopathy

Locations

Country	Name	City	State
India	AIIMS	Rishikesh	Uttarakhand

Sponsors (1)

Lead Sponsor	Collaborator
All India Institute of Medical Sciences, Rishikesh

Country where clinical trial is conducted

India, 

References & Publications (1)

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	=50% or =4 point reduction in an 10-point numeric scale (NRS) at, 1 month, 2 months and 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).	3 months