Trials / Not Yet Recruiting
Not Yet RecruitingNCT07434024
Erector Spinae Plane Block for Acute Low Back Pain
Erector Spinae Plane Block for Acute Low Back Pain: a Prospective Double-blind Randomized Multicenter Study
- Status
- Not Yet Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 300 (estimated)
- Sponsor
- University Hospital, Montpellier · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Non-Specific low back pain (NSLB) is an important public health problem with a major economic and social impact. It is defined by the location of pain, between the lower rib margins and the lumbar vertebrae. Medical management of Non-Specific low back pain injury focuses on reducing pain and its consequences. Nowadays, no strategy has shown optimal effectiveness to improve outcome substantially. The ultrasound-guided erector spinae plane block (ESPB) is a well-known intermuscular compartment block. In the absence of red flag signs, ESPB can be performed for low back pain to reduce pain, decrease opiate requirements and limit emergency admissions for refractory pain. This study aims to evaluate the impact of the ESPB in patients suffering from NSLB.
Detailed description
The study is a multicenter randomized clinical trial. The patients are recruited on the day of admission in the emergency department for Non-Specific low back pain.They are randomly assigned to receive either regional anesthesia with a local anesthetic (ESP BLOCK Group) or placebo (CONTROL Group). The primary objective is to evaluate whether the ESPB is an effective treatment for patients with NSLB pain, by reducing pain and allowing immediate mobility. The secondary objectives of this study are multidimensional and aim to compare patient-reported outcome measures (PROMs) and patient-reported experience measures (PREMs), as well as clinical and economic outcomes, over a six-month follow-up period.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Erector Spinae Plane Block with isotonic saline | Ultrasound-guided erector spinae plane block performed under aseptic conditions by an experienced physician, consisting of an interfascial injection in the erector spinae plane using an isotonic saline solution. |
| PROCEDURE | Erector Spinae Plane Block with local anesthetic | Ultrasound-guided erector spinae plane block performed under aseptic conditions by an experienced physician, consisting of an interfascial injection in the erector spinae plane using a local anesthetic solution. |
Timeline
- Start date
- 2026-03-01
- Primary completion
- 2029-03-01
- Completion
- 2030-01-01
- First posted
- 2026-02-25
- Last updated
- 2026-03-17
Source: ClinicalTrials.gov record NCT07434024. Inclusion in this directory is not an endorsement.