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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04215757
Other study ID # 13
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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