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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

TypeNameDescription
PROCEDUREErector Spinae Plane Block with isotonic salineUltrasound-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.
PROCEDUREErector Spinae Plane Block with local anestheticUltrasound-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.