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

NCT ID: NCT06511765

Last Updated: 2024-07-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-01
• Study Completion Date: 2026-10-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Intravenous injection of Ropivacaine combined with Dexamethasone + usual treatment

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.

Group Type: EXPERIMENTAL

Ropivacaine and dexamethasone injection solution

Intervention Type: DRUG

Injection of Ropivacaine and dexamethasone

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

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.

Group Type: PLACEBO_COMPARATOR

Sodium Chloride 0.9% Injection Solution

Intervention Type: DRUG

Injection of sodium chloride 0.9%

Interventions

Ropivacaine and dexamethasone injection solution

Injection of Ropivacaine and dexamethasone

Intervention Type: DRUG

Sodium Chloride 0.9% Injection Solution

Injection of sodium chloride 0.9%

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Elsan

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Santé Atlantique ELSAN

Saint-Herblain, , France

Countries

France

Central Contacts

Yves MAUGARS, PhD

Role: CONTACT

cyhmla@gmail.com

+33 6 44 36 04 00

Vincent WHYART

Role: CONTACT

vincent.wyart@elsan.care

Facility Contacts

Yves MAUGARS, PhD

Role: primary

Vincent WHYART

Role: backup

vincent.wyart@elsan.care

Other Identifiers

BLOCLOMB

Identifier Type: -

Identifier Source: org_study_id