Study of Ropivacaine and Dexamethasone Injection for Acute Low Back Pain Relief: Testing the Effectiveness of Erector Spinae Muscle Block

3 1 1

What is this study about?

This study examines the effectiveness of a treatment for acute low back pain using an anesthetic nerve block procedure. The treatment involves injecting medications into the erector spinae muscles of the lower back. The medications used in this study include ropivacaine (a local anesthetic), dexamethasone (an anti-inflammatory steroid), and sodium chloride solution.

The purpose of this research is to determine if blocking pain signals in the back muscles can provide relief during the first four days of a recent back pain episode. The study will monitor pain levels both during rest and physical activity. Participants will receive the nerve block treatment and will need to record their pain levels several times per day for the first four days, with additional follow-up assessments continuing for up to 28 days.

Throughout the study, researchers will track various aspects of recovery, including back flexibility, ability to perform daily activities, and any need for additional pain treatments. They will also monitor for any side effects that might occur from the procedure. The total duration of participation for each person will be 28 days, during which they will need to attend several medical visits for evaluations.

1 Initial assessment

Your pain level will be measured using a numeric scale (0-10 rating)

A Schober test will be performed to measure the flexibility of your lower back

You will complete an Oswestry questionnaire to assess how back pain affects your daily activities

2 Treatment procedure

You will receive an injection in the erector spinae muscles (muscles along your spine)

The injection contains ropivacaine (local anesthetic) and dexamethasone (anti-inflammatory medication)

The procedure will be performed while monitoring your vital signs

3 First day monitoring

Your pain levels will be recorded at specific times: 1 hour, 4 hours, 8 hours, and 12 hours after the procedure

Pain will be measured both when you are resting and during activity

Any side effects or complications will be documented

4 Days 1-4 follow-up

Daily pain assessments will continue for the first 4 days

On day 4, a second Schober test will be performed

Your Oswestry score will be reassessed

5 Extended follow-up

Pain levels will continue to be monitored at days 7, 14, 21, and 28

Any additional treatments you receive (such as physical therapy or pain medication) will be recorded

The number of days you are unable to work will be tracked

Any complications or side effects will be monitored throughout the 28-day period

Who Can Join the Study?

  • You can be either male or female
  • You must be 18 years or older
  • You must have low back pain that started less than 7 days ago and hasn’t improved with pain medications or anti-inflammatory drugs
  • Your pain level must be greater than 6 on the pain scale (where 0 means no pain and 10 means worst possible pain)
  • You must have an Oswestry score of 30 or higher (this is a questionnaire that measures how back pain affects your daily activities)
  • You must read and sign an informed consent form before participating in any study procedures
  • You must be willing and able to complete all study-related examinations and procedures as outlined in the study plan
  • You must have active health insurance or social security coverage

Who Cannot Join the Study?

  • Age below 18 or above 65 years
  • Known allergies to any anesthetic medications
  • Pregnancy or breastfeeding
  • History of chronic back pain lasting more than 3 months
  • Previous back surgery
  • Current use of blood thinners or anticoagulation medications (medications that prevent blood clotting)
  • Neurological conditions affecting the spine (diseases affecting nerves and nerve function)
  • Active infection at the injection site
  • Inability to provide informed consent
  • Spinal abnormalities or deformities
  • Current treatment with other pain management procedures
  • Severe mental health conditions that could affect participation
  • History of substance abuse or dependency
  • Participation in another clinical trial within the past 30 days
  • Contraindications to anesthetic procedures (medical reasons why the procedure should not be performed)

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Sante Atlantique Saint-Herblain France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Recruiting
01.04.2025

Trial locations

Local anesthetic block is a medical procedure where an anesthetic medication is injected near specific muscles in the lower back. This treatment targets the erector spinae muscles, which are the long muscles that run along both sides of the spine. The anesthetic helps to reduce pain and muscle tension in people experiencing acute lower back pain (lumbago).

Investigated diseases:

Acute Low Back Pain – A sudden onset condition characterized by pain and discomfort in the lower back region. The pain typically develops within a few days and can affect the muscles, ligaments, and other soft tissues in the lumbar area. It often results from muscle strain or ligament sprain, causing muscle spasms and limited mobility. The condition can make everyday activities difficult and may be accompanied by muscle stiffness and reduced range of motion in the back. Movement typically worsens the pain, while rest may provide temporary relief.

Trial ID:
2024-511818-21-00
Protocol code:
BLOCLOMB
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

  • Efficacy and tolerability of diclofenac potassium + thiocolchicoside versus diclofenac potassium in patients with acute severe low back pain

    Recruiting

    3 1 1
    Cyprus Greece
  • Study comparing diclofenac, orphenadrine and paracetamol combination versus diclofenac alone and orphenadrine-paracetamol combination in patients with acute low back pain

    Recruiting

    3 1 1
    Investigated drugs:
    Greece