Erector Spinae Plane Block for Acute Low Back Pain
ESP-BACK
2 other identifiers
interventional
300
0 countries
N/A
Brief Summary
Non-Specific low back pain (NSLB) is an important public health problem with a major economic and social impact. It is defined by the location of pain, between the lower rib margins and the lumbar vertebrae. Medical management of Non-Specific low back pain injury focuses on reducing pain and its consequences. Nowadays, no strategy has shown optimal effectiveness to improve outcome substantially. The ultrasound-guided erector spinae plane block (ESPB) is a well-known intermuscular compartment block. In the absence of red flag signs, ESPB can be performed for low back pain to reduce pain, decrease opiate requirements and limit emergency admissions for refractory pain. This study aims to evaluate the impact of the ESPB in patients suffering from NSLB.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2026
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 19, 2026
CompletedFirst Posted
Study publicly available on registry
February 25, 2026
CompletedStudy Start
First participant enrolled
March 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2030
March 17, 2026
February 1, 2026
3 years
February 19, 2026
March 13, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of Success of the treatment
The primary endpoint is the success of the treatment before hospital discharge defined by a composite criteria combining the reduction of pain on mobilization (50% decrease in pain intensity) and the validation of the "Get up and go" test (in less than 20 seconds).
30 minutes post-procedure
Secondary Outcomes (13)
VAS Pain assessments
The day of procedure up to 6 months
Brief Pain Inventory (BPI) pain scores
on day 14, month 3, and month 6
Consumption of rescue analgesics
The day of procedure up to 6 months
Steps counts
The day of procedure up to 3 days
Quality of sleep
The day of procedure up to day 3
- +8 more secondary outcomes
Study Arms (2)
Experimental group (ESPB)
EXPERIMENTALA single injection will be performed at the erector spinae plane site, 20 ml of ropivacaine 0.2% then 8 mg of dexamethasone (2 ml) will be administered sequentially through the same needle using two separate syringes in order to prevent the risk of precipitation between the two solutions. The injection will be performed unilaterally or bilaterally as per the randomization stratification
Control group (placebo)
PLACEBO COMPARATORA single injection of 22 ml isotonic saline solution will be performed at the same anatomical site as the experimental group. To maintain the double-blind design, the saline solution will be administered sequentially through the same needle using two separate syringes (20 mL + 2 mL). The injection will also be performed unilaterally or bilaterally, according to the randomization stratification.
Interventions
Ultrasound-guided erector spinae plane block performed under aseptic conditions by an experienced physician, consisting of an interfascial injection in the erector spinae plane using a local anesthetic solution.
Ultrasound-guided erector spinae plane block performed under aseptic conditions by an experienced physician, consisting of an interfascial injection in the erector spinae plane using an isotonic saline solution.
Eligibility Criteria
You may qualify 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 may not qualify 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;
- Referred or chronic pain;
- 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;
- 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;
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 19, 2026
First Posted
February 25, 2026
Study Start
March 1, 2026
Primary Completion (Estimated)
March 1, 2029
Study Completion (Estimated)
January 1, 2030
Last Updated
March 17, 2026
Record last verified: 2026-02