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NCT Number: NCT06511765

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Santé Atlantique ELSAN

Saint-Herblain, 44800, France

Location status: Recruiting

Location contact

Fabian ROY-GASH, MD

SUB_INVESTIGATOR

Vincent WHYART

CONTACT

[email protected]

Yves MAUGARS, PhD

CONTACT

Yves MAUGARS, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient with lumbago lasting less than 7 days despite analgesic / NSAID treatment.
  • Patient with NS pain > 6
  • Patient with Oswestry score > or equal to 30
  • Patient informed of the trial and having signed the informed consent form prior to any trial-specific procedure,
  • Patient willing and able to undergo all planned examinations and procedures in compliance with the clinical trial protocol,
  • Patient affiliated to a social security or any health insurance.

Exclusion criteria

  • 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
  • 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

Treatment and study plan

Ropivacaine and dexamethasone injection solution

Drug

Injection of Ropivacaine and dexamethasone

Sodium Chloride 0.9% Injection Solution

Drug

Injection of sodium chloride 0.9%

Primary outcomes

  1. Lumbar pain in activity

    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)

Secondary outcomes

  1. Consumption of concomitant lumbago treatments

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

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

  2. Lumbar pain at rest

    Time frame: Day 4

    Lumbar pain measured by the patient on a numeric scale

  3. Lumbar pain in activity

    Time frame: Day 4

    Lumbar pain measured by the patient on a numeric scale

  4. Lumbar pain at rest

    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

  5. Lumbar Pain < 3

    Time frame: Day 4

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

  6. Algofunctional index

    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.

  7. Duration of the interruption of current activities

    Time frame: 28 days

    Number of days without current activities

  8. Duration of the interruption of work

    Time frame: 28 days

    Number of days of sick leave

  9. Complications

    Time frame: 28 days

    Complications will focus on the following adverse events:

    • injection-site hematoma, nerve damage, limb pain, convulsions, respiratory discomfort, bradycardia, severe vagal malaise
    • fall, iatrogenic infection
    • new lumbago, sciatica or complicated crural neuralgia (neurological deficit, cauda equina syndrome)
    • allergy, digestive complication, renal complication
    • other to be specified

Study contacts

Contact information is provided by the study sponsor or research team.

Vincent WYART

CONTACT

[email protected]

Yves MAUGARS, PhD

CONTACT

[email protected]

+33 6 44 36 04 00

Sponsors and collaborators

Lead sponsor

Elsan

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 22, 2024
Registry last updated
Jun 10, 2026

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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