Anesthetic block of the erector muscles of the lumbar spine to relieve acute lumbar pain: pilot study

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Sante Atlantique

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Musculoskeletal Diseases [C05]

Trial duration

6 Mar 2026 → ongoing

Decision date (initial)

2024-07-08

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

The main objective is to validate the efficacy of anesthetic blocks of the erector spinae muscles, over the first 4 days, on the pain of muscle contractures, during a recent lumbago.

Secondary objectives 9

1. To evaluate the consumption of analgesics and NSAIDs and others
2. To evaluate pain at D4 following anaesthetic block at rest
3. To evaluate pain at D4 following anaesthetic block in activity
4. To evaluate the area under the curve of the NS pain at rest, at H0-4-8-12 and D1-2-3-4-7-14-21-28 days.
5. To evaluate the percentage of patients with EN rest pain < 3 at D4
6. To evaluate an algofunctional index (OSWESTRY) at D0, D4 and D28
7. To evaluate the duration of the interruption of current and professional activities until D28
8. To evaluate the number of complications : (a) during the operation (b) away from the block (c) disc-related (d) drug-induced (e) other
9. To evaluate the mobility of the lumbar spine

Conditions and MedDRA coding

Acute law back pain

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. Male or female
2. Age ≥ 18 years
3. Patient with lumbago lasting less than 7 days despite analgesic / NSAID treatment.
4. Patient with NS pain > 6
5. Patient with Oswestry score ≥ 30
6. Patient informed of the trial and having signed the informed consent form prior to any trial-specific procedure
7. Patient willing and able to undergo all planned examinations and procedures in compliance with the clinical trial protocol
8. Patient affiliated to a social security or any health insurance

Exclusion criteria 14

1. Presence of "red flag" (non-disc lumbago): o Motor deficit or signs of horsetail irritation o Inflammatory pain waking up in the 2nd half of the night o Tumoral context o Infectious context or fever o Altered general condition o Traumatic context o 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. Pregnant or breastfeeding woman or woman refusing effective contraception
11. Patient deprived of liberty or under legal protection (guardianship or curatorship)
12. Patient participating in another clinical research protocol involving a drug or medical device
13. Patient unable to follow the protocol, as judged by the investigator
14. Patient refusing to participate in the study

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary endpoint will be the area under the curve of NS (numeric scale) pain in activity over the first 4 days, with values reported on a monitoring log or observation book at H0-1-4-8-12 and D1-2-3-4.

Secondary endpoints 9

1. NS (numeric scale) pain at rest at D4
2. NS pain in activity at D4
3. The area under the curve of the NS pain at rest is based on values recorded in a monitoring logbook and observation book at H0-4-8-12 and D1-2-3-4-7-14-21-28 days.
4. NS pain at D4
5. OSWESTRY algofunctional index
6. Number of days off work up to D28
7. Complications will focus on the following adverse events: (a) injection-site hematoma, nerve damage, limb pain, convulsions, respiratory discomfort, bradycardia, severe vagal malaise (b) fall, iatrogenic infection (c) new lumbago, sciatica or complicated crural neuralgia (neurological deficit, cauda equina syndrome) (d) allergy, digestive complication, renal complication (e) other to be specified
8. Recording of analgesics and NSAIDs, physiotherapy, manipulations, open surgery, etc.
9. Schober test performed at D0 and D4

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Sante Atlantique

Sponsor organisation

Sante Atlantique

Address

Avenue Claude Bernard

City

St Herblain

Postcode

44800

Country

France

Scientific contact point

Organisation

Sante Atlantique

Contact name

Yves Maugars

Public contact point

Organisation

Sante Atlantique

Contact name

Vincent Wyart

Locations

1 EU/EEA country · 2 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 11 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications