Santé Atlantique ELSAN
Saint-Herblain, 44800, France
Location status: Recruiting
Location contact
Fabian ROY-GASH, MD
SUB_INVESTIGATOR
Vincent WHYART
CONTACT
Yves MAUGARS, PhD
CONTACT
Yves MAUGARS, PhD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT06511765
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 3
Saint-Herblain, 44800, France
Location status: Recruiting
Fabian ROY-GASH, MD
SUB_INVESTIGATOR
Vincent WHYART
CONTACT
Yves MAUGARS, PhD
CONTACT
Yves MAUGARS, PhD
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Injection of Ropivacaine and dexamethasone
Injection of sodium chloride 0.9%
Time frame: At Hour 0-Hour1-Hour4-Hour8-Hour12 and Day 1-Day2-Day3-Day4. (Hour 0=injection time, Day 1=One day after injection time)
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)
Time frame: From Day 0 (day of injection) to Day 4
Recording of analgesics and NSAIDs, physiotherapy, manipulations, open surgery, etc
Time frame: Day 4
Lumbar pain measured by the patient on a numeric scale
Time frame: Day 4
Lumbar pain measured by the patient on a numeric scale
Time frame: At Hour 0-Hour1-Hour4-Hour8-Hour12 and Day 1-Day 2-Day 3-Day 4-Day 7-Day 14-Day 21-Day 28
Area under the curve of lumbar pain at rest measured by the patient on a numeric scale
Time frame: Day 4
Percentage of patients with pain < 3 (measured by the patient on a numeric scale, at rest)
Time frame: Day 0, Day 4 and Day 28
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.
Time frame: 28 days
Number of days without current activities
Time frame: 28 days
Number of days of sick leave
Time frame: 28 days
Complications will focus on the following adverse events:
Contact information is provided by the study sponsor or research team.
Vincent WYART
CONTACT
Yves MAUGARS, PhD
CONTACT
Elsan
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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