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This study concerns the treatment of recent lumbago and aims to evaluate the efficacy of an anesthetic block of the erector spinae muscles combining ropivacaine and dexamethasone. This treatment is routinely used in several institutions in France, but has never been the subject of a randomized placebo-controlled study to assess its efficacy at D4 of treatment.
The BLOCLOMB comparative, randomized, double-blind study aims to validate the efficacy, over the first 4 days, of anesthetic blocks of the erector spinae muscles, during recent lumbago, on the pain of muscular contractures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravenous injection of Ropivacaine combined with Dexamethasone + usual treatment | Experimental | The experimental treatment consists in one single interlaminal injection of 2x20ml Ropivacaine (0.375%) distributed over the L4-L5 (Lumbar vertebrae 4 and 5) and L5-S1 (Lumbar vertebrae 5 and sacrum 1) levels on both sides, combined with 2x4ml Dexamethasone soluble (i.e. 2x1ml). This dose and method of administration are those required for locoregional anesthesia. |
|
| Intravenous injection of Placebo (sodium chloride 0.9%) + usual treatment | Placebo Comparator | The placebo treatment consists in one single interlaminal injection of 2x20ml sodium chloride 0.9% distributed over the L4-L5 and L5-S1 levels on both sides. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ropivacaine and dexamethasone injection solution | Drug | Injection of Ropivacaine and dexamethasone |
|
| Measure | Description | Time Frame |
|---|---|---|
| Lumbar pain in activity | Area under the curve of lumbar pain in activity measured by the patient on a numeric scale (from 0=no pain, and 10=unbearable pain) | At Hour 0-Hour1-Hour4-Hour8-Hour12 and Day 1-Day2-Day3-Day4. (Hour 0=injection time, Day 1=One day after injection time) |
| Measure | Description | Time Frame |
|---|---|---|
| Consumption of concomitant lumbago treatments | Recording of analgesics and NSAIDs, physiotherapy, manipulations, open surgery, etc | From Day 0 (day of injection) to Day 4 |
| Lumbar pain at rest | Lumbar pain measured by the patient on a numeric scale |
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Inclusion Criteria:
Exclusion Criteria:
Presence of "red flag" (non-disc lumbago):
Risk of infection
Patient with poor local skin condition
Patient on AVK or anti-Xa anticoagulation, or bleeding disorder (antiaggregants authorized)
Patients with hypersensitivity to Ropivacaine or any of its excipients: Sodium chloride, hydrochloric acid sodium hydroxide
Patient with sciatica
Patient with chronic respiratory insufficiency
Patient with cardiac rhythm disorders
Pregnant or breastfeeding woman or woman refusing effective contraception
Patient deprived of liberty or under legal protection (guardianship or curator)
Patient participating in another clinical research protocol involving a drug or medical device
Patient unable to follow the protocol, as judged by the investigator
Patient refusing to participate in the study
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yves MAUGARS, PhD | Contact | +33 6 44 36 04 00 | cyhmla@gmail.com | |
| Vincent WYART | Contact | vincent.wyart@elsan.care |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Santé Atlantique ELSAN | Recruiting | Saint-Herblain | 44800 | France |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| D010146 | Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Sodium Chloride 0.9% Injection Solution | Drug | Injection of sodium chloride 0.9% |
|
| Day 4 |
| Lumbar pain in activity | Lumbar pain measured by the patient on a numeric scale | Day 4 |
| Lumbar pain at rest | Area under the curve of lumbar pain at rest measured by the patient on a numeric scale | At Hour 0-Hour1-Hour4-Hour8-Hour12 and Day 1-Day 2-Day 3-Day 4-Day 7-Day 14-Day 21-Day 28 |
| Lumbar Pain < 3 | Percentage of patients with pain < 3 (measured by the patient on a numeric scale, at rest) | Day 4 |
| Algofunctional index | Oswestry questionnaire: comprises 10 questions on pain, personal care, load-bearing, walking, sitting, standing, sleep, sex life, social life and travel. Each question offers 6 answers, with a score from 0 to 6, which the patient must choose; a score of 0 corresponds to normal function, and a score of 6 to severely impaired function. The score obtained is multiplied by 2 to obtain a percentage of disability, with 0% for no disability, and 100% for the greatest disability. | Day 0, Day 4 and Day 28 |
| Duration of the interruption of current activities | Number of days without current activities | 28 days |
| Duration of the interruption of work | Number of days of sick leave | 28 days |
| Complications | Complications will focus on the following adverse events:
| 28 days |
| D000588 |
| Amines |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |