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Can a skin injection of ketamine and lidocaine tame CRPS pain?

NCT ID NCT04650074

Symptom relief Sponsor: Hospices Civils de Lyon Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 10, 2026 · Last updated Aug 11, 2026 · Updated 1 time

Summary

This trial tests whether injecting a mix of ketamine and lidocaine into the skin, a technique called mesotherapy, can reduce neuropathic pain in people with complex regional pain syndrome type 1 (CRPS1). Participants receive four sessions of either the drug mixture or lidocaine alone. The study measures pain levels and other symptoms to see if this approach offers a new way to manage this difficult condition.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
A mixture of ketamine and lidocaine injected into the skin via mesotherapy
What this could lead to
If effective, this approach could offer a new, well-tolerated way to manage chronic neuropathic pain in CRPS1, potentially reducing reliance on systemic medications.
What could go wrong
This is a small pilot study, and results may not be conclusive or generalizable. The treatment's effectiveness and safety are not yet established, and mesotherapy carries risks like injection-site reactions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

31 people

The number who actually took part.

Started

Nov 2021

Finished

Jan 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Male / female aged ≥18 years, * Patient suffering from Complex Regional Pain Syndrome Type 1 (CRPS1), according to the Budapest criteria, with a neuropathic component limited to the lower or upper limbs diagnosed by the Neuropathic pain DN4 Questionnaire * Patient having undergone a three-stage dynamic bone scan less than 3 months old : vascular, tissue, bone, showing diffuse and extensive hyperfixation in the area suspected of CRPS1, * Negative urinary pregnancy test in women of childbearing age, * VAS (Visual Analogue Scale) \> 50mm (on a scale of 0 to 100 mm) at inclusion, * Patients affiliated to the French social security system, * Writing informed consent obtained. Exclusion Criteria: * Patient with the following medical history or ongoing pathologies: epilepsy, hypertension (\> 180mm / 100mm Hg), unbalanced coronary artery disease, recent myocardial infarction (MDI) (less than 12 months), porphyria, hyperthyroidism, known Behçet's disease, known blood crass disorder or PT (Prothrombin Time) \<20%, known psychiatric disorders, known septic osteoarticular disease, * Patient with HIV ((Human Immunodeficiency Viruses) infection, immunosuppression and / or immunosuppressive treatment * Severe heart failure, * History of severe allergy (angioedema), * Known allergies to Cr and Zn, * Current skin infection, * Skin lesion next to the injection area * Phobia of injections, * Known hypersensitivity to ketamine hydrochloride or chlorobutanol, * Known hypersensitivity to lidocaine hydrochloride or to amide-linked local anesthetics, * Pregnant or breastfeeding woman * Patient under protective measure (safeguard measure, curatorship, guardianship) or deprived of liberty.

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Conditions

The condition(s) this trial relates to.

complex regional pain syndrome complex regional pain syndrome type 1 neuralgia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Complex regional pain syndrome type 1 Neuropathic pain

Contacts and locations

Locations

  • Department of orthopedic surgery and trauma emergencies of the lower limb, Edouard Herriot Hospital, Hospices Civils de Lyon

    Lyon, 69437, France

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