Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Authorised, recruitment pending
Participants planned
300
Countries
1
Sites
8
Acute low back pain
Evaluate the effectiveness of the erector spinae plane block (ESPB) in managing patients with non-specific low back (NSLB) pain, by reducing pain and allowing immediate mobility.
Key facts
- Sponsor
- Centre Hospitalier Universitaire De Montpellier
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Decision date (initial)
- 2025-11-26
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- DGOS
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
Evaluate the effectiveness of the erector spinae plane block (ESPB) in managing patients with non-specific low back (NSLB) pain, by reducing pain and allowing immediate mobility.
Secondary objectives 6
- Evaluate the effectiveness of the ESPB to promote the patient's experience (PREMs) by reducing pain and improving quality of life.
- Evaluate the effectiveness of the ESPB to improve functional rehabilitation (PROMs) by promoting early walk's resumption and physical activity.
- Evaluate the effectiveness of the ESPB to reduce the recurrence of low back pain episodes.
- Evaluate the effectiveness of the ESPB to reduce side effects related to rescue medications (such as nausea, vomiting, and chronic opioid consumption).
- Evaluate the effectiveness of the ESPB to facilitate earlier return to work.
- Evaluate the cost-utility of ESPB compared to standard of care.
Conditions and MedDRA coding
Acute low back pain
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | LLT | 10000683 | Acute back pain | 10028395 |
| 21.0 | LLT | 10024891 | Low back pain | 10028395 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Randomization procedure Randomization will be performed using a minimization process and will be stratified by study centers and by the side of the block administration (unilateral or bilateral) with a ratio (1:1) and 150 patients per group, the design will define the treatment administered according to the two groups: ESP BLOCK group versus Control group.
|
Randomised Controlled | Double | [{"id":156400,"code":2,"name":"Investigator"},{"id":156401,"code":1,"name":"Subject"}] | Experimental arm: ropivacaïne 0.2% (20 ml) and 8 mg dexamethasone (2 ml) Control arm: isotonic saline solution NaCl 0.9 % (total 22 ml) |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Adult (≥ 18 years)
- Non-specific low back pain (≤ 5 days)
- Pain score (VAS) ≥ 5 (during mobilization)
- Inability to walk easily (failure of the "Get Up and Go" test in less than 20 seconds)
Exclusion criteria 26
- Low back pain of known specific origin: spine surgery, spine trauma, discal hernia, facet joint, radicular (sciatica, cruralgia, meralgia paresthetica), muscle pain, cancer-related or rheumatological disease
- Acute inflammatory diseases (e.g., rheumatoid arthritis, ankylosing spondylitis…)
- Patient with severe hypotension or uncontrolled hypertension or; Heart Block (uncorrected second- or third-degree heart block without a pacemaker) or; severe bradycardia
- Patients with severe liver or renal disease or peptic ulcer disease
- Presence of infection or sepsis at the injection site
- Patients with uncontrolled bacterial, viral, or protozoan infections or; systemic fungal infections or; active untreated tuberculosis or; active ocular herpes simplex infections
- Patients with uncontrolled diabetes mellitus
- Patients with glaucoma or history of severe glaucoma
- Patients with severe psychiatric conditions
- Subject unable to read or/and write (inability to complete a self-administered questionnaire)
- Unavailability for follow up during 6 months
- Referred or chronic pain
- Participation in another clinical trial involving an investigational medicinal product or medical device within 4 weeks preceding the screening date
- Pregnancy in progress or planned during the study period or breastfeeding women (Art. L1121-5 of the French Public Health Code)
- Patients protected by law (Art. L1121-6 and L1121-8 of the French Public Health Code): Individuals deprived of their liberty by judicial or administrative decision, minors, adults under law protection or unable to express their consent or patient under guardianship or curatorship
- Patients not covered by a French social security scheme or not benefiting from such a scheme
- Absence of signed informed consent form before inclusion from the patient
- Patient already included in the study
- Patients with opioids (acute or chronic pain and/or misuse)
- Contraindication to regional anaesthesia
- Contraindication to ropivacaine, dexamethasone, sodium chloride, NSAID, paracetamol, tramadol
- Known hypersensitivity to ropivacaine, dexamethasone, other amide-type local anesthetics, or any of the excipients
- Addiction to drugs, alcohol or medication
- Patients with anticoagulants for a curative use (not preventive)
- Patients with cancer or risk of bone metastasis or; severe osteoporosis
- Women of childbearing potential (WOCBP) without a negative of highly sensitive pregnancy test before inclusion or not using a highly effective method of contraception
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- Reduction of pain on mobilization (50 % decrease in pain intensity) 30 minutes after the procedure
- Validation of the "Get Up and Go" test (completed in less than 20 seconds) 30 minutes after the procedure
Secondary endpoints 15
- Patient-reported VAS pain score from day 0 to month 6
- Score of the Brief Pain Inventory (BPI) questionnaire on day 14, month 3, and month 6
- Consumption of rescue analgesic (tramadol) from day 0 to month 6 (total number of tablets)
- Steps count from day 0 to day 3
- Quality of sleep (sleep duration, sleep onset and awakeness numbers in hours) from day 0 to day 3
- Score of EIFEL questionnaire on day 3
- Score of WOMAC questionnaire on day 14, month 3, and month 6
- Number of medical consultations for low back pain up to month 6
- Number of physiotherapy sessions for low back pain up to month 6
- Number of recurrences of low back pain up to month 6
- Score of SF-12 questionnaire, at month 3 and month 6
- Side effects related to rescue analgesics (such as nausea, vomiting…) up to month 6
- Opioid misuse will be assessed with the score of POMI questionnaire on day 14, month 3, and month 6
- Number of days from the procedure to the time returning to work up to month 6
- The incremental cost-utility ratio (ICUR) at 6 months, based on costs collected in the study CRF and on utility values derived from the EQ-5D-5L questionnaire
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
SUB01612MIG · Substance
- Active substance
- Dexamethasone Phosphate
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SOLUTION FOR INJECTION
- Max daily dose
- 2 ml millilitre(s)
- Max total dose
- 2 ml millilitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB04264MIG · Substance
- Active substance
- Ropivacaine Hydrochloride
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SOLUTION FOR INJECTION
- Max daily dose
- 20 ml millilitre(s)
- Max total dose
- 20 ml millilitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
SUB12581MIG · Substance
- Active substance
- Sodium Chloride
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SOLUTION FOR INJECTION
- Max daily dose
- 22 ml millilitre(s)
- Max total dose
- 22 ml millilitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Auxiliary 5
SUB09611MIG · Substance
- Active substance
- Paracetamol
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 4 g gram(s)
- Max total dose
- 20 g gram(s)
- Max treatment duration
- 5 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB09611MIG · Substance
- Active substance
- Paracetamol
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- SOLUTION FOR INFUSION
- Max daily dose
- 1000 mg milligram(s)
- Max total dose
- 1000 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB08374MIG · Substance
- Active substance
- Ketoprofen
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 200 mg milligram(s)
- Max total dose
- 1000 mg milligram(s)
- Max treatment duration
- 5 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB08374MIG · Substance
- Active substance
- Ketoprofen
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- SOLUTION FOR INFUSION
- Max daily dose
- 100 mg milligram(s)
- Max total dose
- 100 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB04927MIG · Substance
- Active substance
- Tramadol Hydrochloride
- Pharmaceutical form
- PROLONGED-RELEASE TABLET
- Route of administration
- ORAL
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 1500 mg milligram(s)
- Max treatment duration
- 5 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Centre Hospitalier Universitaire De Montpellier
- Sponsor organisation
- Centre Hospitalier Universitaire De Montpellier
- Address
- 191 Avenue Du Doyen Gaston Giraud
- City
- Montpellier Cedex 5
- Postcode
- 34295
- Country
- France
Scientific contact point
- Organisation
- Centre Hospitalier Universitaire De Montpellier
- Contact name
- CAPDEVILA Xavier
Public contact point
- Organisation
- Centre Hospitalier Universitaire De Montpellier
- Contact name
- CAPDEVILA Xavier
Locations
1 EU/EEA country · 8 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Authorised, recruitment pending | 300 | 8 |
| Rest of world | — | 0 | — |
Investigational sites
Clinique De La Sauvegarde
Anesthésie et Réanimation, Avenue David Ben Gourion Lieudit, 69009, Lyon
Centre Hospitalier Universitaire De Nimes
Anesthésie et Réanimation, 4 Place Du Professeur Robert Debre, Bp 40026, Nimes Cedex 9
Polyclinique Sainte Thérèse
Anesthésie et Réanimation, 6 Quai du Mas Coulet, 34200, Sète
Polyclinique Saint Jean
Anesthésie et Réanimation, 92-94 Av. Dr Maurice Donat, 06800, Cagnes-sur-Mer
Centre Hospitalier Universitaire De Nice
Anesthésie et Réanimation, 30 Voie Romaine, 06000, Nice
Centre Hospitalier Universitaire De Montpellier
Anesthésie et Réanimation, 371 Avenue Du Doyen Gaston Giraud, 34090, Montpellier
Centre Hospitalier Universitaire De Toulouse
Anesthésie et Réanimation, 1 Place Du Docteur Joseph Baylac, 31300, Toulouse
Clinique Drouot Rémusat
Anesthésie et Réanimation, 21 Rue de Rémusat 75016 Paris, France
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 15 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2024-511595-32-00 | 1.2 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1.1 |
| Subject information and informed consent form (for publication) | D4_Echelle EIFEL | 1 |
| Subject information and informed consent form (for publication) | D4_Echelle EVA | 1 |
| Subject information and informed consent form (for publication) | D4_Echelle POMI | 1 |
| Subject information and informed consent form (for publication) | D4_Indice WOMAC | 1 |
| Subject information and informed consent form (for publication) | D4_Patient Diary | 1 |
| Subject information and informed consent form (for publication) | D4_Questionnaire BPI | 1 |
| Subject information and informed consent form (for publication) | D4_Questionnaire EQ5D-5L | 1 |
| Subject information and informed consent form (for publication) | D4_Questionnaire SF12 | 1 |
| Subject information and informed consent form (for publication) | L1_ICF participant | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS participant | 1.2 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_DEXAMETHASONE MEDISOL | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_ROPIVACAINE KABI | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_FR 2024-511595-32-00 | 2 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-08-10 | France | Acceptable 2025-11-20
|
2025-11-26 |