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

NCT06511765 | Not Yet Recruiting Phase 3

• 1 other identifier: BLOCLOMB
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lumbago

Keywords

anesthetic blocks; pain

Outcome Measures

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)

  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 (9)

• Consumption of concomitant lumbago treatments

  From Day 0 (day of injection) to Day 4

• Lumbar pain at rest

  Day 4

• Lumbar pain in activity

  Day 4

• Lumbar pain at rest

  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

  Day 4

Study Arms (2)

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.

Drug: Ropivacaine and dexamethasone injection solution

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.

Drug: Sodium Chloride 0.9% Injection Solution

Interventions

Ropivacaine and dexamethasone injection solution DRUG

Injection of Ropivacaine and dexamethasone

Intravenous injection of Ropivacaine combined with Dexamethasone + usual treatment

Sodium Chloride 0.9% Injection Solution DRUG

Injection of sodium chloride 0.9%

Intravenous injection of Placebo (sodium chloride 0.9%) + usual treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Elsan: lead

Study Sites (1)

Santé Atlantique ELSAN

Saint-Herblain, 44800, France

Location

MeSH Terms

Conditions

Low Back Pain; Pain

Interventions

Ropivacaine; Sodium Chloride

Condition Hierarchy (Ancestors)

Back Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

Yves MAUGARS, PhD

CONTACT

+33 6 44 36 04 00; cyhmla@gmail.com

Vincent WHYART

CONTACT

vincent.wyart@elsan.care

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2024
• First Posted: July 22, 2024
• Study Start: September 1, 2024
• Primary Completion (Estimated): September 4, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: July 22, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)