LumbagoPhase 3NCT06511765
Anesthetic Block of the Erector Muscles of the Lumbar Spine to Relieve Acute Lumbar Pain: Pilot Study
A Phase 3 study testing Ropivacaine and dexamethasone injection solution and Sodium Chloride 0.9% Injection Solution in people with Lumbago, run by Elsan at 1 site in France.
Trial summary
This study concerns the treatment of recent lumbago and aims to evaluate the efficacy of an anesthetic block of the erector spinae muscles combining ropivacaine and dexamethasone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lumbago
- What is being tested?
- Ropivacaine and dexamethasone injection solution and Sodium Chloride 0.9% Injection Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 24 Mar 2026to 31 Oct 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- Patient with lumbago lasting less than 7 days despite analgesic / NSAID treatment.
- Patient with NS pain > 6
- Patient with Oswestry score > or equal to 30
- Patient informed of the trial and having signed the informed consent form prior to any trial-specific procedure,
- Patient willing and able to undergo all planned examinations and procedures in compliance with the clinical trial protocol,
- Patient affiliated to a social security or any health insurance.
Who cannot join
- Presence of "red flag" (non-disc lumbago):
- Motor deficit or signs of horsetail irritation
- Inflammatory pain waking up in the 2nd half of the night
- Tumoral context
- Infectious context or fever
- Altered general condition
Show all 20Show fewer
- Traumatic context
- Osteoporotic context
- Risk of infection
- Patient with poor local skin condition
- Patient on AVK or anti-Xa anticoagulation, or bleeding disorder (antiaggregants authorized)
- Patients with hypersensitivity to Ropivacaine or any of its excipients: Sodium chloride, hydrochloric acid sodium hydroxide
- Patient with sciatica
- Patient with chronic respiratory insufficiency
- Patient with cardiac rhythm disorders
- Pregnant or breastfeeding woman or woman refusing effective contraception
- Patient deprived of liberty or under legal protection (guardianship or curator)
- Patient participating in another clinical research protocol involving a drug or medical device
- Patient unable to follow the protocol, as judged by the investigator
- Patient refusing to participate in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Vincent WYART contact
France1 site, 1 recruiting
- Recruiting
Santé Atlantique ELSAN
Saint-Herblain, 44800
Yves MAUGARS, PhD
Vincent WHYART, vincent.wyart@elsan.care
About this study
This study concerns the treatment of recent lumbago and aims to evaluate the efficacy of an anesthetic block of the erector spinae muscles combining ropivacaine and dexamethasone. This treatment is routinely used in several institutions in France, but has never been the subject of a randomized placebo-controlled study to assess its efficacy at D4 of treatment.
The BLOCLOMB comparative, randomized, double-blind study aims to validate the efficacy, over the first 4 days, of anesthetic blocks of the erector spinae muscles, during recent lumbago, on the pain of muscular contractures.
- Conditions
- Lumbago
- Being tested
- Ropivacaine and dexamethasone injection solution, Sodium Chloride 0.9% Injection Solution
- Keywords
- anesthetic blocks, pain
- Medical subject headings
- Low Back Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ropivacaine and dexamethasone injection solutionDrug
Injection of Ropivacaine and dexamethasone
Sodium Chloride 0.9% Injection SolutionDrug
Injection of sodium chloride 0.9%
| Study group | Role | What they receive |
|---|---|---|
| Intravenous injection of Ropivacaine combined with Dexamethasone + usual treatment | Experimental | The experimental treatment consists in one single interlaminal injection of 2x20ml Ropivacaine (0.375%) distributed over the L4-L5 (Lumbar vertebrae 4 and 5) and L5-S1 (Lumbar vertebrae 5 and sacrum 1) levels on both sides, combined with 2x4ml Dexamethasone soluble (i.e. 2x1ml). This dose and method of administration are those required for locoregional anesthesia. Receives: Drug: Ropivacaine and dexamethasone injection solution |
| Intravenous injection of Placebo (sodium chloride 0.9%) + usual treatment | Placebo comparator | The placebo treatment consists in one single interlaminal injection of 2x20ml sodium chloride 0.9% distributed over the L4-L5 and L5-S1 levels on both sides. Receives: Drug: Sodium Chloride 0.9% Injection Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lumbar pain in activity
Area under the curve of lumbar pain in activity measured by the patient on a numeric scale (from 0=no pain, and 10=unbearable pain)
Measured: At Hour 0-Hour1-Hour4-Hour8-Hour12 and Day 1-Day2-Day3-Day4. (Hour 0=injection time, Day 1=One day after injection time)
Secondary outcomes (9)
Consumption of concomitant lumbago treatments
Recording of analgesics and NSAIDs, physiotherapy, manipulations, open surgery, etc
Measured: From Day 0 (day of injection) to Day 4
Lumbar pain at rest
Lumbar pain measured by the patient on a numeric scale
Measured: Day 4
Lumbar pain in activity
Lumbar pain measured by the patient on a numeric scale
Measured: Day 4
Lumbar pain at rest
Area under the curve of lumbar pain at rest measured by the patient on a numeric scale
Measured: At Hour 0-Hour1-Hour4-Hour8-Hour12 and Day 1-Day 2-Day 3-Day 4-Day 7-Day 14-Day 21-Day 28
Lumbar Pain < 3
Percentage of patients with pain < 3 (measured by the patient on a numeric scale, at rest)
Measured: Day 4
Algofunctional index
Oswestry questionnaire: comprises 10 questions on pain, personal care, load-bearing, walking, sitting, standing, sleep, sex life, social life and travel. Each question offers 6 answers, with a score from 0 to 6, which the patient must choose; a score of 0 corresponds to normal function, and a score of 6 to severely impaired function.
The score obtained is multiplied by 2 to obtain a percentage of disability, with 0% for no disability, and 100% for the greatest disability.
Measured: Day 0, Day 4 and Day 28
Duration of the interruption of current activities
Number of days without current activities
Measured: 28 days
Duration of the interruption of work
Number of days of sick leave
Measured: 28 days
Complications
Complications will focus on the following adverse events:
- injection-site hematoma, nerve damage, limb pain, convulsions, respiratory discomfort, bradycardia, severe vagal malaise
- fall, iatrogenic infection
- new lumbago, sciatica or complicated crural neuralgia (neurological deficit, cauda equina syndrome)
- allergy, digestive complication, renal complication
- other to be specified
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study start24 Mar 2026
- Primary completion4 Sep 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LumbagoStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Elsan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06511765
- Sponsor's protocol ID
- BLOCLOMB
- Status last verified
- Jun 2026
- First submitted
- 3 Jul 2024
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anesthetic Block of the Erector Muscles of the Lumbar Spine to Relieve Acute Lumbar Pain: Pilot Study
- ClinicalTrials.gov ID
- NCT06511765
- Acronym / sponsor ID
- BLOCLOMB
- Conditions
- Lumbago
- Keywords
- anesthetic blocks, pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- ElsanUniversity, hospital or other
- Study start
- 24 Mar 2026 (actual)
- Primary completion
- 4 Sep 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 22 Jul 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.
This study concerns the treatment of recent lumbago and aims to evaluate the efficacy of an anesthetic block of the erector spinae muscles combining ropivacaine and dexamethasone. This treatment is routinely used in several institutions in France, but has never been the subject of a randomized placebo-controlled study to assess its efficacy at D4 of treatment.
The BLOCLOMB comparative, randomized, double-blind study aims to validate the efficacy, over the first 4 days, of anesthetic blocks of the erector spinae muscles, during recent lumbago, on the pain of muscular contractures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravenous injection of Ropivacaine combined with Dexamethasone + usual treatment | Experimental | Drug: Ropivacaine and dexamethasone injection solutionThe experimental treatment consists in one single interlaminal injection of 2x20ml Ropivacaine (0.375%) distributed over the L4-L5 (Lumbar vertebrae 4 and 5) and L5-S1 (Lumbar vertebrae 5 and sacrum 1) levels on both sides, combined with 2x4ml Dexamethasone soluble (i.e. 2x1ml). This dose and method of administration are those required for locoregional anesthesia. |
| Intravenous injection of Placebo (sodium chloride 0.9%) + usual treatment | Placebo comparator | Drug: Sodium Chloride 0.9% Injection SolutionThe placebo treatment consists in one single interlaminal injection of 2x20ml sodium chloride 0.9% distributed over the L4-L5 and L5-S1 levels on both sides. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient with lumbago lasting less than 7 days despite analgesic / NSAID treatment.
- Patient with NS pain > 6
- Patient with Oswestry score > or equal to 30
- Patient informed of the trial and having signed the informed consent form prior to any trial-specific procedure,
- Patient willing and able to undergo all planned examinations and procedures in compliance with the clinical trial protocol,
Key exclusion criteria (20 listed)
- Presence of "red flag" (non-disc lumbago):
- Risk of infection
- Patient with poor local skin condition
- Patient on AVK or anti-Xa anticoagulation, or bleeding disorder (antiaggregants authorized)
- Patients with hypersensitivity to Ropivacaine or any of its excipients: Sodium chloride, hydrochloric acid sodium hydroxide
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 |
|---|---|---|
| Ropivacaine and dexamethasone injection solutionInjection of Ropivacaine and dexamethasone | Drug | Intravenous injection of Ropivacaine combined with Dexamethasone + usual treatment |
| Sodium Chloride 0.9% Injection SolutionInjection of sodium chloride 0.9% | Drug | Intravenous injection of Placebo (sodium chloride 0.9%) + usual treatment |
Primary outcome
Lumbar pain in activity
Time frame: At Hour 0-Hour1-Hour4-Hour8-Hour12 and Day 1-Day2-Day3-Day4. (Hour 0=injection time, Day 1=One day after injection time)
Area under the curve of lumbar pain in activity measured by the patient on a numeric scale (from 0=no pain, and 10=unbearable pain)
9 secondary outcomes
Consumption of concomitant lumbago treatments
Time frame: From Day 0 (day of injection) to Day 4
Lumbar pain at rest
Time frame: Day 4
Lumbar pain in activity
Time frame: Day 4
Lumbar pain at rest
Time frame: At Hour 0-Hour1-Hour4-Hour8-Hour12 and Day 1-Day 2-Day 3-Day 4-Day 7-Day 14-Day 21-Day 28
Lumbar Pain < 3
Time frame: Day 4
Algofunctional index
Time frame: Day 0, Day 4 and Day 28
Duration of the interruption of current activities
Time frame: 28 days
Duration of the interruption of work
Time frame: 28 days
Complications
Time frame: 28 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Lumbago
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
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.
Vincent WYART contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ropivacaine and dexamethasone injection solution and Sodium Chloride 0.9% Injection Solution in people with Lumbago, run by Elsan at 1 site 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 6 inclusion and 20 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: looking for participants now, as of the sponsor's last update on 10 Jun 2026. 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yves MAUGARS, PhD (+33 6 44 36 04 00, cyhmla@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lumbar pain in activity (time frame: At Hour 0-Hour1-Hour4-Hour8-Hour12 and Day 1-Day2-Day3-Day4. (Hour 0=injection time, Day 1=One day after injection time)). 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 10 Jun 2026.