StrokePhase 3APEDOCNCT06446960
The Role of Peripheral Afferents in Modulating Post-stroke Central Pain
A Phase 3 study testing Lidocaine 20mg/ml, Levobupivacaine Hydrochloride 1.25 MG/ML and Sodium Chloride 0.9% Inj in people with Stroke, run by Institut National de la Santé Et de la Recherche Médicale, France at 2 sites in France.
Trial summary
Central post-stroke pain (CPP) is extremely difficult to relieve and responds very poorly to analgesics targeting neuropathic pain, probably because the mechanisms underlying this pain remain poorly understood. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Lidocaine 20mg/ml, Levobupivacaine Hydrochloride 1.25 MG/ML and Sodium Chloride 0.9% Inj
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 2 sitesFrance
- Study dates
- 9 Feb 2024to 4 Jun 2026
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 years and over with no maximum age (blocks are generally very well tolerated in the very elderly)
- Pain in the upper or lower limb distal enough to be completely covered by a peripheral nerve block
- Chronic pain for at least 6 months
- Ischaemic or haemorrhagic stroke for at least 6 months documented clinically and by appropriate imaging (MRI)
- Post-stroke central neuropathic pain defined as pain occurring in the aftermath of stroke meeting the criteria for probable or defined neuropathic pain according to the NeuPSIG algorithm and with a DN4 screening questionnaire score of at least 4 out of 10.
- Spontaneous pain intensity greater than or equal to 4 out of 10 on an 11-point numerical scale (EN) at inclusion and randomisation (i.e. just before each block)
Show all 9Show fewer
- Patients affiliated to a social security scheme or beneficiaries of such a scheme
- Stable oral analgesic pharmacological treatment for at least 2 weeks prior to inclusion
- Acceptance and signing of the informed consent
Who cannot join
- Inability or unwillingness to sign an informed consent
- Person subject to a legal protection measure (safeguard of justice, curatorship, guardianship)
- Patients with ongoing psychiatric pathology (major depression, psychosis) or cognitive disorders that prevent a good understanding of the protocol and questionnaires
- Pain that is too widespread in one hemicycle or limb and cannot be adequately covered by blocks
- Ongoing drug or substance abuse
- Language (aphasia) or comprehension disorders, illiteracy
Show all 14Show fewer
- Moderate to severe renal or hepatic impairment
- Contraindication to local anaesthetics for use in perineural blocks (infection or acute inflammation in the injection area, known allergy).
- Pregnancy or breastfeeding
- Known hypersensitivity to lidocaine, levobupivacaine, amide-linked local anaesthetics or to any of the excipients contained in the specialities used in the study.
- Patients with recurrent porphyria or severe hypotension contraindicating treatment with lidocaine and/or levobupivacaine
- Current treatment with antiarrhythmic drugs causing torsades de pointes (amiodarone, disopyramide, quinidinics, sotalol...) or with antiarrhythmic drugs with local anaesthetic activity (mexiletine or class III antiarrhythmic drugs) and cannot be discontinued.
- Too little pain at the time of the blocks (< 4 out of 10)
- Need to modify analgesic pharmacological treatment at the beginning or during the study
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHU Ambroise Paré
Boulogne-Billancourt, 92100
Hôpital Raymond Poincaré
Garches, 92380
About this study
Central post-stroke pain (CPP) is extremely difficult to relieve and responds very poorly to analgesics targeting neuropathic pain, probably because the mechanisms underlying this pain remain poorly understood.
Stroke pain is traditionally considered to be of central origin and related to changes in the spinal cord and/or brain nociceptive systems. However, a recent study in a small cohort of patients has suggested that the peripheral nervous system (PNS) may have a role in the initiation and persistence of APD.
The main objective of this prospective randomised controlled bicentric study (Raymond Poincaré and Ambroise Paré) in double blind and parallel groups against placebo (3 arms) will be to evaluate the efficacy of two peripheral nerve blocks performed 14 days apart on spontaneous neuropathic pain after stroke. The active treatments used for the blocks will be either lidocaine 20 mg/ml or levobupivacaine 1.25 mg/ml or placebo (saline)
Read the detailed description
The primary endpoint will be the change in neuropathic pain intensity (assessed on an 11-point pain intensity scale), expressed as a difference in pain intensity between the value obtained before each block and that obtained 45 minutes after, corresponding to the maximum expected effect. Secondary endpoints will include exertional pain, pain quality, % relief, clinical global impression, pain assessment on a patient diary for a fortnight after each block and adverse events.
Patients will be randomised to receive one of 3 study treatments (lidocaine 2%, levobupivacaine 1.25 mg/ml or placebo). The treatment protocol will involve 2 perineural blocks performed 14 days apart. Assessment will continue for up to 2 weeks after each block, i.e. up to one month after the start of treatment. An evaluation of pain will be carried out before the block and after each block, at 45 minutes and at 5 hours, and then daily by the patient on a self-evaluation booklet for the 14 days following each block.
Randomisation will be centralised on a server from a list drawn up in advance by computer rogramme, balanced by blocks of variable size. Allocation between the 3 arms will be done according to a balanced 1:1:1 distribution. Treatments will be numbered from 1 to n, and allocated to patients in the chronological order of their inclusion in the trial.
Patients will be randomised on the day of treatment using a centralised computerised randomisation procedure to receive one of the 3 study treatments (lidocaine 20 mg/ml levobupivacaine 1.25 mg/ml or saline). No matching by age or duration of pain is planned, as randomisation usually results in groups matched at baseline on these criteria. The treatment will be administered over two visits performed 14 days apart by a qualified anaesthetist using the peri-nervous route according to current ecommendations (see above). Only one randomisation will be performed at baseline, so that a patient on active treatment cannot receive placebo at a later date and vice versa (see figure 1).
The investigators plan to randomise 10 patients per group and a total of 30 patients to achieve 90% power with a two sided α risk=0.05,. Given the estimated premature discontinuation rate, the investigators consider it necessary to include 12 patients per group for a total of 36 patients.
This study opens the way to new therapeutic avenues for these patients who often fail all treatments
- Conditions
- Stroke
- Being tested
- Lidocaine 20mg/ml, Levobupivacaine Hydrochloride 1.25 MG/ML, Sodium Chloride 0.9% Inj
- Keywords
- Ischemic Stroke, Central Neuropathic Pain
- Medical subject headings
- Stroke, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine 20mg/mlDrug
2 bolus administrations at 14 day intervals Route of administration: Peri-Nervous Dosage for administration: 20ml
Levobupivacaine Hydrochloride 1.25 MG/MLDrug
2 bolus administrations at 14 day intervals Route of administration: Peri-Nervous Dosage for administration: 20ml
Sodium Chloride 0.9% InjDrug
2 bolus administrations at 14 day intervals Route of administration: Peri-Nervous Dosage for administration: 20ml
| Study group | Role | What they receive |
|---|---|---|
| lidocaine 20 mg/ml | Experimental | Name (INN and/or speciality) : Lidocaine 20 mg/ml Pharmaceutical form: Injectable Route of administration: Peri-Nervous Dosage for administration: 20ml Duration of treatment: 2 bolus administrations at 14 day intervals Receives: Drug: Lidocaine 20mg/ml |
| levobupivacaine 1.25 mg/ml | Experimental | Name (INN and/or speciality) : Levobupivacaine (Chirocaine), 1.25 mg/ml Pharmaceutical form: Injectable Route of administration: Peri-Nervous Dosage for administration: 20ml Duration of treatment: 2 bolus administrations at 14 day intervals Receives: Drug: Levobupivacaine Hydrochloride 1.25 MG/ML |
| Sodium chloride (NaCl) 0.9 | Placebo comparator | Name (INN and/or speciality) : Sodium chloride (NaCl) 0.9 Pharmaceutical form: Injectable Route of administration: Peri-Nervous Dosage for administration: 20ml Duration of treatment: 2 bolus administrations at 14 day intervals Receives: Drug: Sodium Chloride 0.9% Inj |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the efficacy of two peripheral nerve blocks performed 14 days apart on spontaneous neuropathic pain after stroke. The active treatments used for the blocks will be either lidocaine 20mg/ml or levobupivacaine 1.25mg/ml or placebo (saline)
The evolution in neuropathic pain intensity assessed on an 11-point pain intensity scale (0 = no pain: 10: maximum imaginable pain), expressed as a difference in pain intensity between the value obtained before each block and that obtained 45 minutes after, corresponding to the maximum expected effect. The values obtained before and after each block will first be analysed individually and then combined for the two successive blocks for each patient and the comparison will be between the three treatment arms, lidocaine 20mg/ml, levobupivacaine 1.25mg/ml or placebo
Rationale for the choice of the main criterion :
Pain intensity will be assessed on a numerical scale that corresponds to the usual validated measurement criterion and the choice of 45 minutes corresponds to the maximum effect of local anaesthetics
Measured: 24 months
Secondary outcomes (8)
- To evaluate the time course and duration of the effectiveness of the nerve blocks on spontaneous pain on a pain intensity scale completed daily by the patient on a self-evaluation booklet up to 14 days after each block.
- Comparison of the duration (in days) of efficacy of lidocaine 20 mg/ml levobupivacaine 1.25 mg/ml and placebo blocks on spontaneous and exertional pain assessed by an 11-point pain intensity scale (0 to 10) completed daily by the patient on a self-report diary, up to 14 days after each block.
Measured: 24 months
- Evaluate the effectiveness of blocks on exercise pain
- Comparison of the efficacy of levobupicacaine 1.25 mg/ml, lidocaine 20 mg/ml and placebo on spontaneous and exertional pain assessed by an 11-point pain intensity scale (0 to 10) at 45 minutes and then at 5 hours after the block and then daily on a self-evaluation booklet, up to 14 days after each block
Measured: 24 months
- Directly compare the efficacy of active blocks, i.e. lidocaine and levobupivacaine, on spontaneous and provoked pain (allodynia)
- Comparison of the efficacy of lidocaine, levobupivacaine and placebo blocks on the intensity of rubbing pain if present (dynamic mechanical allodynia) assessed before treatment with a brush and then at 45 minutes and at 5 hours after each block.
- Comparison of the efficacy of lidocaine, levobupivacaine and placebo blocks on spontaneous and provoked pain area (mechanical allodynia if present) assessed by a tracing (and then plotted on a graph allowing measurement of area in cm2) before treatment and then at 45 minutes and at 5 hours after each block using a method used in our previous studies
Measured: 24 months
- Evaluate the effectiveness of each block on provoked pain (mechanical allodynia), mechanical, hot and cold pain thresholds and pain area
- Comparison of the efficacy of lidocaine, levobupivacaine and placebo blocks on mechanical pain and detection thresholds assessed by Semmes Weinstein monofilaments (calibrated from 0.057 g to 300 g) as well as on thermal pain and detection thresholds assessed by a thermotest before the treatment and at 45 minutes and at 5 hours after each block
Measured: 24 months
- Evaluate the effectiveness of each block on the dimensions of neuropathic pain assessed by the NPSI questionnaire
- Comparison of the efficacy of lidocaine, levobupivacaine and placebo blocks on dimensions of neuropathic pain assessed by the NPSI questionnaire before treatment and at 45 minutes, and at 5 hours and 2 weeks after each block
Measured: 24 months
- To evaluate the effectiveness of the blocks on the overall clinical impression, the percentage of relief as well as the satisfaction with the treatment
Evaluation of adverse effects of lidocaine, levobupivacaine and placebo blocks after the blocks and up to 14 days after each block.
- Efficacy of lidocaine, levobupivacaine and placebo blocks on patient (PGIC) and examiner (CGIC) clinical global impression at 45 minutes, and at 5 hours and 2 weeks after each block.
- Proportion of responders to lidocaine, levobupivicaine and placebo treatments assessed at 45 minutes, ad at 5 hours and 2 weeks after each block.
Measured: 24 months
- Assessing the adverse effects of each treatment
- Evaluation of adverse effects of lidocaine, levobupivacaine and placebo blocks after the blocks and up to 14 days after each block
Measured: 24 months
- Assessing the maintenance of blinding by a blinding questionnaire at the end of the study
- Blinding assessment by a blinding questionnaire at the end of the study for each patient
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2024
- Study start9 Feb 2024
- Primary completion4 Jun 2026
- Study completion4 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomised to receive one of 3 study treatments (lidocaine 20 mg/ml, levobupivacaine 1.25 mg/ml, or saline).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06446960
- Sponsor's protocol ID
- C23-05
- Other IDs
- 2023-504676-17-00, 2023
- Acronym
- APEDOC
- Status last verified
- Oct 2026
- First submitted
- 30 Jan 2024
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Peripheral Afferents in Modulating Post-stroke Central Pain
- ClinicalTrials.gov ID
- NCT06446960
- Acronym / sponsor ID
- APEDOC / C23-05
- Conditions
- Stroke
- Keywords
- Ischemic Stroke, Central Neuropathic Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Study start
- 9 Feb 2024 (actual)
- Primary completion
- 4 Jun 2026 (actual)
- Study completion
- 4 Jun 2026 (actual)
- First posted
- 6 Jun 2024 (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.
Central post-stroke pain (CPP) is extremely difficult to relieve and responds very poorly to analgesics targeting neuropathic pain, probably because the mechanisms underlying this pain remain poorly understood.
Stroke pain is traditionally considered to be of central origin and related to changes in the spinal cord and/or brain nociceptive systems. However, a recent study in a small cohort of patients has suggested that the peripheral nervous system (PNS) may have a role in the initiation and persistence of APD.
The main objective of this prospective randomised controlled bicentric study (Raymond Poincaré and Ambroise Paré) in double blind and parallel groups against placebo (3 arms) will be to evaluate the efficacy of two peripheral nerve blocks performed 14 days apart on spontaneous neuropathic pain after stroke. The active treatments used for the blocks will be either lidocaine 20 mg/ml or levobupivacaine 1.25 mg/ml or placebo (saline)
Detailed description
The primary endpoint will be the change in neuropathic pain intensity (assessed on an 11-point pain intensity scale), expressed as a difference in pain intensity between the value obtained before each block and that obtained 45 minutes after, corresponding to the maximum expected effect. Secondary endpoints will include exertional pain, pain quality, % relief, clinical global impression, pain assessment on a patient diary for a fortnight after each block and adverse events.
Patients will be randomised to receive one of 3 study treatments (lidocaine 2%, levobupivacaine 1.25 mg/ml or placebo). The treatment protocol will involve 2 perineural blocks performed 14 days apart. Assessment will continue for up to 2 weeks after each block, i.e. up to one month after the start of treatment. An evaluation of pain will be carried out before the block and after each block, at 45 minutes and at 5 hours, and then daily by the patient on a self-evaluation booklet for the 14 days following each block.
Randomisation will be centralised on a server from a list drawn up in advance by computer rogramme, balanced by blocks of variable size. Allocation between the 3 arms will be done according to a balanced 1:1:1 distribution. Treatments will be numbered from 1 to n, and allocated to patients in the chronological order of their inclusion in the trial.
Patients will be randomised on the day of treatment using a centralised computerised randomisation procedure to receive one of the 3 study treatments (lidocaine 20 mg/ml levobupivacaine 1.25 mg/ml or saline). No matching by age or duration of pain is planned, as randomisation usually results in groups matched at baseline on these criteria. The treatment will be administered over two visits performed 14 days apart by a qualified anaesthetist using the peri-nervous route according to current ecommendations (see above). Only one randomisation will be performed at baseline, so that a patient on active treatment cannot receive placebo at a later date and vice versa (see figure 1).
The investigators plan to randomise 10 patients per group and a total of 30 patients to achieve 90% power with a two sided α risk=0.05,. Given the estimated premature discontinuation rate, the investigators consider it necessary to include 12 patients per group for a total of 36 patients.
This study opens the way to new therapeutic avenues for these patients who often fail all treatments
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Patients will be randomised to receive one of 3 study treatments (lidocaine 20 mg/ml, levobupivacaine 1.25 mg/ml, or saline).
| Arm | Type | Receives |
|---|---|---|
| lidocaine 20 mg/ml | Experimental | Drug: Lidocaine 20mg/mlName (INN and/or speciality) : Lidocaine 20 mg/ml Pharmaceutical form: Injectable Route of administration: Peri-Nervous Dosage for administration: 20ml Duration of treatment: 2 bolus administrations at 14 day intervals |
| levobupivacaine 1.25 mg/ml | Experimental | Drug: Levobupivacaine Hydrochloride 1.25 MG/MLName (INN and/or speciality) : Levobupivacaine (Chirocaine), 1.25 mg/ml Pharmaceutical form: Injectable Route of administration: Peri-Nervous Dosage for administration: 20ml Duration of treatment: 2 bolus administrations at 14 day intervals |
| Sodium chloride (NaCl) 0.9 | Placebo comparator | Drug: Sodium Chloride 0.9% InjName (INN and/or speciality) : Sodium chloride (NaCl) 0.9 Pharmaceutical form: Injectable Route of administration: Peri-Nervous Dosage for administration: 20ml Duration of treatment: 2 bolus administrations at 14 day intervals |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients aged 18 years and over with no maximum age (blocks are generally very well tolerated in the very elderly)
- Pain in the upper or lower limb distal enough to be completely covered by a peripheral nerve block
- Chronic pain for at least 6 months
- Ischaemic or haemorrhagic stroke for at least 6 months documented clinically and by appropriate imaging (MRI)
- Post-stroke central neuropathic pain defined as pain occurring in the aftermath of stroke meeting the criteria for probable or defined neuropathic pain according to the NeuPSIG algorithm and with a DN4 screening questionnaire score of at least 4 out of 10.
Key exclusion criteria (14 listed)
- Inability or unwillingness to sign an informed consent
- Person subject to a legal protection measure (safeguard of justice, curatorship, guardianship)
- Patients with ongoing psychiatric pathology (major depression, psychosis) or cognitive disorders that prevent a good understanding of the protocol and questionnaires
- Pain that is too widespread in one hemicycle or limb and cannot be adequately covered by blocks
- Ongoing drug or substance abuse
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 |
|---|---|---|
| Lidocaine 20mg/ml2 bolus administrations at 14 day intervals Route of administration: Peri-Nervous Dosage for administration: 20ml | Drug | lidocaine 20 mg/ml |
| Levobupivacaine Hydrochloride 1.25 MG/ML2 bolus administrations at 14 day intervals Route of administration: Peri-Nervous Dosage for administration: 20ml | Drug | levobupivacaine 1.25 mg/ml |
| Sodium Chloride 0.9% Inj2 bolus administrations at 14 day intervals Route of administration: Peri-Nervous Dosage for administration: 20ml | Drug | Sodium chloride (NaCl) 0.9 |
Primary outcome
To evaluate the efficacy of two peripheral nerve blocks performed 14 days apart on spontaneous neuropathic pain after stroke. The active treatments used for the blocks will be either lidocaine 20mg/ml or levobupivacaine 1.25mg/ml or placebo (saline)
Time frame: 24 months
The evolution in neuropathic pain intensity assessed on an 11-point pain intensity scale (0 = no pain: 10: maximum imaginable pain), expressed as a difference in pain intensity between the value obtained before each block and that obtained 45 minutes after, corresponding to the maximum expected effect. The values obtained before and after each block will first be analysed individually and then combined for the two successive blocks for each patient and the comparison will be between the three treatment arms, lidocaine 20mg/ml, levobupivacaine 1.25mg/ml or placebo Rationale for the choice of the main criterion : Pain intensity will be assessed on a numerical scale that corresponds to the usual validated measurement criterion and the choice of 45 minutes corresponds to the maximum effect of local anaesthetics
8 secondary outcomes
- To evaluate the time course and duration of the effectiveness of the nerve blocks on spontaneous pain on a pain intensity scale completed daily by the patient on a self-evaluation booklet up to 14 days after each block.
Time frame: 24 months
- Evaluate the effectiveness of blocks on exercise pain
Time frame: 24 months
- Directly compare the efficacy of active blocks, i.e. lidocaine and levobupivacaine, on spontaneous and provoked pain (allodynia)
Time frame: 24 months
- Evaluate the effectiveness of each block on provoked pain (mechanical allodynia), mechanical, hot and cold pain thresholds and pain area
Time frame: 24 months
- Evaluate the effectiveness of each block on the dimensions of neuropathic pain assessed by the NPSI questionnaire
Time frame: 24 months
- To evaluate the effectiveness of the blocks on the overall clinical impression, the percentage of relief as well as the satisfaction with the treatment
Time frame: 24 months
- Assessing the adverse effects of each treatment
Time frame: 24 months
- Assessing the maintenance of blinding by a blinding questionnaire at the end of the study
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lidocaine 20mg/ml, Levobupivacaine Hydrochloride 1.25 MG/ML and Sodium Chloride 0.9% Inj in people with Stroke, run by Institut National de la Santé Et de la Recherche Médicale, France at 2 sites in France.
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 9 inclusion and 14 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: finished, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the efficacy of two peripheral nerve blocks performed 14 days apart on spontaneous neuropathic pain after stroke. The active treatments used for the blocks will be either lidocaine 20mg/ml or levobupivacaine 1.25mg/ml or placebo (saline) (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Oct 2026.