BridgeMD
ESP-BACK : Erector Spinae Plane Block for acute low back pain
EU CTIS ID: 2024-511595-32-00
What this study is testing
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.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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)
You likely can't join if
- 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
- 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)
See the full eligibility criteria
- 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)
- 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
- 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)
- Acute inflammatory diseases (e.g., rheumatoid arthritis, ankylosing spondylitis…)
- 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
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.