Anesthetic Block of the Erector Muscles of the Lumbar Spine to Relieve Acute Lumbar Pain: Pilot Study

Phase 3RecruitingNCT06511765

Elsan40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Lumbago

Interventions

Ropivacaine and dexamethasone injection solution

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patient with lumbago lasting less than 7 days despite analgesic / NSAID treatment. 2. Patient with NS pain \> 6 3. Patient with Oswestry score \> or equal to 30 4. Patient informed of the trial and having signed the informed consent form prior to any trial-specific procedure, 5. Patient willing and able to undergo all planned examinations and procedures in compliance with the clinical trial protocol, 6. Patient affiliated to a social security or any health insurance. Exclusion Criteria: 1. Presence of "red flag" (non-disc lumbago): * Motor deficit or signs of horsetail irritation * Inflammatory pain waking up in the 2nd half of the night * Tumoral context * Infectious context or fever * Altered general condition * Traumatic context * Osteoporotic context 2. Risk of infection 3. Patient with poor local skin condition 4. Patient on AVK or anti-Xa anticoagulation, or bleeding disorder (antiaggregants authorized) 5. Patients with hypersensitivity to Ropivacaine or any of its excipients: Sodium chloride, hydrochloric acid sodium hydroxide 6. Patient with sciatica 7. Patient with chronic respiratory insufficiency 8. Patient with cardiac rhythm disorders 9. Pregnant or breastfeeding woman or woman refusing effective contraception 10. Patient deprived of liberty or under legal protection (guardianship or curator) 11. Patient participating in another clinical research protocol involving a drug or medical device 12. Patient unable to follow the protocol, as judged by the investigator 13. Patient refusing to participate in the study

Outcomes

Primary Outcomes

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)

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)

Secondary Outcomes

Consumption of concomitant lumbago treatments

Recording of analgesics and NSAIDs, physiotherapy, manipulations, open surgery, etc

Time frame: From Day 0 (day of injection) to Day 4

Lumbar pain at rest

Lumbar pain measured by the patient on a numeric scale

Time frame: Day 4

Lumbar pain in activity

Lumbar pain measured by the patient on a numeric scale

Time frame: Day 4

Lumbar pain at rest

Area under the curve of lumbar pain at rest 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

Lumbar Pain < 3

Percentage of patients with pain \< 3 (measured by the patient on a numeric scale, at rest)

Time frame: 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.

Time frame: Day 0, Day 4 and Day 28

Duration of the interruption of current activities

Number of days without current activities

Time frame: 28 days

Duration of the interruption of work

Number of days of sick leave

Time frame: 28 days

Complications

Complications will focus on the following adverse events: 1. injection-site hematoma, nerve damage, limb pain, convulsions, respiratory discomfort, bradycardia, severe vagal malaise 2. fall, iatrogenic infection 3. new lumbago, sciatica or complicated crural neuralgia (neurological deficit, cauda equina syndrome) 4. allergy, digestive complication, renal complication 5. other to be specified

Time frame: 28 days

Anesthetic Block of the Erector Muscles of the Lumbar Spine to Relieve Acute Lumbar Pain: Pilot Study

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts