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

NCT ID: NCT04215757

Last Updated: 2020-01-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-20
• Study Completion Date: 2020-01-30

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.

Conditions

Pain, Acute

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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%)

Group Type: EXPERIMENTAL

peripheral nerve block

Intervention Type: PROCEDURE

peripheral nerve blocks with low dose lignocaine in acute radiculopathy

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

Group Type: PLACEBO_COMPARATOR

peripheral nerve block

Intervention Type: PROCEDURE

peripheral nerve blocks with low dose lignocaine in acute radiculopathy

Interventions

peripheral nerve block

peripheral nerve blocks with low dose lignocaine in acute radiculopathy

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

All India Institute of Medical Sciences, Rishikesh

OTHER_GOV

Sponsor Role: lead

Responsible Party

ADABALA VIJAY BABU

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Vijay Adabala, MD

Role: PRINCIPAL_INVESTIGATOR

AIIMS Rishikesh

Locations

AIIMS

Rishikesh, Uttarakhand, India

Site Status: RECRUITING

Countries

India

Central Contacts

AJIT KUMAR, MD

Role: CONTACT

ajitdr.ajit@gmail.com

9910789377

References

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.

Reference Type: RESULT

PMID: 22806363 (View on PubMed)

Other Identifiers

13

Identifier Type: -

Identifier Source: org_study_id