Recruiting

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

Registered drug

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 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
Step 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
Step 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
Step 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
Step 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 trial?

8 criteria

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 trial?

15 criteria

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)

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

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).

What is already known about the treatment

Anesthetic block - A local anesthetic procedure used to treat acute low back pain by targeting the erector spinae muscles in the lumbar region of the spine. This medical intervention involves injecting anesthetic medication directly into specific points along the back muscles to provide pain relief and reduce muscle contractures. The treatment is currently being studied in clinical trials as a potential short-term solution for acute lower back pain management, with the focus on effectiveness during the first four days of symptoms. The procedure belongs to the class of local anesthetic treatments and works by temporarily blocking pain signals from the affected muscles to the brain.

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.