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

Primary Purpose

Pain, Acute

Status
Unknown status
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
peripheral nerve block
Sponsored by
All India Institute of Medical Sciences, Rishikesh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Acute

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • AIIMSRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intervention group

Control group

Arm Description

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%)

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

Outcomes

Primary Outcome Measures

≥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).

Secondary Outcome Measures

Full Information

First Posted
December 30, 2019
Last Updated
December 30, 2019
Sponsor
All India Institute of Medical Sciences, Rishikesh
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1. Study Identification

Unique Protocol Identification Number
NCT04215757
Brief Title
Low Dose Lignocaine Injections as a Treatment Option for Acute Lumbosacral Radiculopathy
Official Title
PERIPHERAL NERVE BLOCKS WITH LOW DOSE LIGNOCAINE FOR THE TREATMENT OF ACUTE LUMBOSACRAL RADICULOPATHY
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 20, 2019 (Actual)
Primary Completion Date
January 15, 2020 (Anticipated)
Study Completion Date
January 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
All India Institute of Medical Sciences, Rishikesh

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Acute

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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%)
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
peripheral nerve block
Intervention Description
peripheral nerve blocks with low dose lignocaine in acute radiculopathy
Primary Outcome Measure Information:
Title
≥50% or ≥4 point reduction in an 10-point numeric scale (NRS) at, 1 month, 2 months and 3 months.
Description
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).
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
AJIT KUMAR, MD
Phone
9910789377
Email
ajitdr.ajit@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vijay Adabala, MD
Organizational Affiliation
AIIMS Rishikesh
Official's Role
Principal Investigator
Facility Information:
Facility Name
AIIMS
City
Rishikesh
State/Province
Uttarakhand
ZIP/Postal Code
249203
Country
India
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
once the study is finished
IPD Sharing Time Frame
6 months
IPD Sharing Access Criteria
on web
Citations:
PubMed Identifier
22806363
Citation
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.
Results Reference
result

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

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