Health TrialsbyHealthPanel

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

ConditionLumbago
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorElsan

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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,

Disqualifiers

Motor deficit or signs of horsetail irritation

Inflammatory pain waking up in the 2nd half of the night

Tumoral context

Infectious context or fever

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ropivacaine and dexamethasone injection solution

    Drug

    Injection of Ropivacaine and dexamethasone

  • Sodium Chloride 0.9% Injection Solution

    Drug

    Injection of sodium chloride 0.9%

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Intravenous injection of Ropivacaine combined with Dexamethasone + usual treatmentExperimental treatment 1 intervention
Group B: Intravenous injection of Placebo (sodium chloride 0.9%) + usual treatmentPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

1

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
2

Lumbar pain at rest

Lumbar pain measured by the patient on a numeric scale

Time frame
Day 4
3

Lumbar pain in activity

Lumbar pain measured by the patient on a numeric scale

Time frame
Day 4
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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Elsan

Lead sponsor

Source ClinicalTrials.gov
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