Erector Spinae Plane Block for Acute Low Back Pain
ConditionNon-specific Low Back Pain (NSLBP)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Montpellier
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
Erector Spinae Plane Block with isotonic saline
Procedure/SurgeryUltrasound-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.
Erector Spinae Plane Block with local anesthetic
Procedure/SurgeryUltrasound-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.
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: Experimental group (ESPB)Experimental treatment 1 intervention
Group B: Control group (placebo)Placebo comparator 1 intervention
Trial outcomes
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).
Time frame
30 minutes post-procedureSecondary outcomes
1
VAS Pain assessments
The Visual Analog Scale (VAS) will provide a subjective evaluation of pain severity by the patient on a scale ranging from 0 to 10, where 0 signifies no pain and 10 represents the most intense pain imaginable. This measurement is essential for capturing the patient's own perception of pain following the intervention.
Time frame
The day of procedure up to 6 months2
Brief Pain Inventory (BPI) pain scores
The Brief Pain Inventory (BPI) questionnaire serves as a comprehensive tool for assessing the severity of pain and its impact on various aspects of daily life. By capturing detailed information about pain experiences, including its intensity, interference with daily activities, and emotional impact, the BPI facilitates a nuanced understanding of the patient's pain experience. The BPI includes 2 subdimensions (pain severity and pain interference) range from 0 (no pain or no interference) to 10 (worst imaginable pain / complete interference)
Time frame
on day 14, month 3, and month 63
Consumption of rescue analgesics
Consumption of rescue analgesic (total number of tablets of tramadol)
Time frame
The day of procedure up to 6 months4
Steps counts
Activity levels will be continuously monitored for 3 days using smartwatch technology. Metrics such as the number of steps taken will be recorded.
Time frame
The day of procedure up to 3 daysLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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