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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-511595-32-00 | EU Trial (CTIS) Number |
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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.
The study is a multicenter randomized clinical trial. The patients are recruited on the day of admission in the emergency department for Non-Specific low back pain.They are randomly assigned to receive either regional anesthesia with a local anesthetic (ESP BLOCK Group) or placebo (CONTROL Group). The primary objective is to evaluate whether the ESPB is an effective treatment for patients with NSLB pain, by reducing pain and allowing immediate mobility. The secondary objectives of this study are multidimensional and aim to compare patient-reported outcome measures (PROMs) and patient-reported experience measures (PREMs), as well as clinical and economic outcomes, over a six-month follow-up period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group (ESPB) | Experimental | A 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 |
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| Control group (placebo) | Placebo Comparator | A 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erector Spinae Plane Block with isotonic saline | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | The day of procedure up to 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sophie Bringuier, Pharm D PhD | Contact | +33467338661 | s-bringuierbranchereau@chu-montpellier.fr | |
| Xavier Cadevila, MD PHD | Contact | x-capdevila@chu-montpellier.fr |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| D000779 | Anesthetics, Local |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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The study is a prospective double-blind randomized multicenter study: ESP BLOCK Group versus CONTROL Group
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| Erector Spinae Plane Block with local anesthetic | Procedure | 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. |
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| 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) | on day 14, month 3, and month 6 |
| Consumption of rescue analgesics | Consumption of rescue analgesic (total number of tablets of tramadol) | The day of procedure up to 6 months |
| 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. | The day of procedure up to 3 days |
| Quality of sleep | Sleep duration will be continuously monitored for 3 days using smartwatch technology. | The day of procedure up to day 3 |
| EIFEL score | The EIFEL questionnaireis a 24-item self-administered questionnaire, adapted from the Roland and Morris Disability Questionnaire, used to assess the functional impact of low back pain. For each of the 24 statements, the patient must tick the box if the statement corresponds to their current situation. If the patient is bedridden due to back pain, they must tick the specific box provided before the 24 statements and stop completing the questionnaire. The total score is calculated by summing the number of boxes ticked. A higher total score reflects a greater functional impairment related to low back pain | on day 3 |
| WOMAC scores | The WOMAC questionnaire is a self-administered questionnaire consisting of 24 items divided into three subscales: pain (5 items), stiffness (2 items) and physical Function (17 items). Each item is scored from 0 to 4, yielding a total score ranging from 0 (no disability) to 96 (severe disability). The WOMAC provides valuable insights into the patient's pain levels, stiffness, physical function, and overall impact on daily living. | on day 14, month 3, and month 6 |
| Quality of life SF12 Scores | The SF12 questionnaire is a self-reported outcome measure assessing the impact of health on an individual's everyday life. Patients fill out a 12-question survey across multiple domains covering physical and mental health. Two summary measures will be obtained: the Physical Component Summary (PCS) and the Mental Component Summary (MCS) range from 0 (worst) to 100 (best) quality of life. | at month 3 and month 6 |
| Health-related quality of life Scores | The EQ-5D-5L is a questionnaire used to measure a person's health-related quality of life. It includes five dimensions-mobility, self-care, usual activities, pain/discomfort, and anxiety/depression-each rated on five levels of severity. The responses form a code that describes the person's health state. It also includes a visual analogue scale (VAS) where individuals rate their overall health on a scale from 0 (worst) to 100 (best) | The day of procedure and at 6 month |
| Opioid misuse | The POMI questionnaire is a 6-item self-administered questionnaire designed to detect opioid misuse behaviour. Each YES answer is counted as 1 point and each NO answer is counted as 0 points. A score of 2 points or more indicates an opioid use disorder | on day 14, month 3, and month 6 |
| Time to return to work | Tracking the time taken for patients to return to work following treatment provides valuable insights into functional recovery and rehabilitation outcomes | at month 6 |
| Number of physiotherapy sessions | The Number of physiotherapy sessions for low back pain willbe recorded | At month 6 |
| Number of recurrences | Number of recurrences of low back pain willbe recorded | at month 6 |
| D017670 |
| Sodium Compounds |
| D000777 | Anesthetics |
| D002492 | Central Nervous System Depressants |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |