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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04215757
Recruitment Status : Recruiting
First Posted : January 2, 2020
Last Update Posted : January 2, 2020
Sponsor:
Information provided by (Responsible Party):
ADABALA VIJAY BABU, 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.

Condition or disease Intervention/treatment Phase
Pain, Acute Procedure: peripheral nerve block Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: PERIPHERAL NERVE BLOCKS WITH LOW DOSE LIGNOCAINE FOR THE TREATMENT OF ACUTE LUMBOSACRAL RADICULOPATHY
Actual Study Start Date : January 20, 2019
Estimated Primary Completion Date : January 15, 2020
Estimated Study Completion Date : January 30, 2020

Arm Intervention/treatment
Experimental: Intervention group

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%)

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

Placebo Comparator: Control group

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

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




Primary Outcome Measures :
  1. ≥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).



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04215757


Contacts
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Contact: AJIT KUMAR, MD 9910789377 ajitdr.ajit@gmail.com

Locations
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India
AIIMS Recruiting
Rishikesh, Uttarakhand, India, 249203
Sponsors and Collaborators
All India Institute of Medical Sciences, Rishikesh
Investigators
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Principal Investigator: Vijay Adabala, MD AIIMS Rishikesh
Publications of Results:
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Responsible Party: ADABALA VIJAY BABU, Principal Investigator, All India Institute of Medical Sciences, Rishikesh
ClinicalTrials.gov Identifier: NCT04215757    
Other Study ID Numbers: 13
First Posted: January 2, 2020    Key Record Dates
Last Update Posted: January 2, 2020
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: once the study is finished
Supporting Materials: Study Protocol
Clinical Study Report (CSR)
Time Frame: 6 months
Access Criteria: on web

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Radiculopathy
Acute Pain
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations