Pain, AcuteNCT04215757
Low Dose Lignocaine Injections as a Treatment Option for Acute Lumbosacral Radiculopathy
A study testing peripheral nerve block in people with Pain, Acute, run by All India Institute of Medical Sciences, Rishikesh at 1 site in India.
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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Pain, Acute
- What is being tested?
- peripheral nerve block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteIndia
- Study dates
- 20 Jan 2019to 30 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PERIPHERAL NERVE BLOCKS WITH LOW DOSE LIGNOCAINE FOR THE TREATMENT OF ACUTE LUMBOSACRAL RADICULOPATHY
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.
Read the 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
- Being tested
- peripheral nerve block
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
peripheral nerve blockProcedure or surgery
peripheral nerve blocks with low dose lignocaine in acute radiculopathy
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | 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%) Receives: Procedure: peripheral nerve block |
| Control group | Placebo comparator | 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 Receives: Procedure: peripheral nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
≥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).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2020
- Study start20 Jan 2019
- Primary completion15 Jan 2020 (estimated)
- Study completion30 Jan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- All India Institute of Medical Sciences, Rishikesh
- Sponsor type
- Other government
- Responsible party
- Principal investigator, ADABALA VIJAY BABU, All India Institute of Medical Sciences, Rishikesh
- Investigators
- Vijay Adabala, MD, Principal investigator, AIIMS Rishikesh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04215757
- Sponsor's protocol ID
- 13
- Status last verified
- Dec 2019
- First submitted
- 30 Dec 2019
- Last updated
- 2 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: once the study is finished
Publications
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.
PubMed 22806363
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PERIPHERAL NERVE BLOCKS WITH LOW DOSE LIGNOCAINE FOR THE TREATMENT OF ACUTE LUMBOSACRAL RADICULOPATHY
- ClinicalTrials.gov ID
- NCT04215757
- Acronym / sponsor ID
- 13
- Conditions
- Pain, Acute
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- All India Institute of Medical Sciences, RishikeshOther government
- Study start
- 20 Jan 2019 (actual)
- Primary completion
- 15 Jan 2020 (estimated)
- Study completion
- 30 Jan 2020 (estimated)
- First posted
- 2 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Procedure: peripheral nerve blockPatient 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%) |
| Control group | Placebo comparator | Procedure: peripheral nerve blockPatients 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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| peripheral nerve blockperipheral nerve blocks with low dose lignocaine in acute radiculopathy | Procedure or surgery | Control group, Intervention group |
Primary outcome
≥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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2020.
- Results publication: PubMed 22806363Levinson 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.
- Individual participant dataSharing planned: Yes. once the study is finished
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vijay Adabala, MD principal investigator
AIIMS Rishikesh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing peripheral nerve block in people with Pain, Acute, run by All India Institute of Medical Sciences, Rishikesh at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact AJIT KUMAR, MD (9910789377, ajitdr.ajit@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
≥50% or ≥4 point reduction in an 10-point numeric scale (NRS) at, 1 month, 2 months and 3 months. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04215757, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2020.