Erector Spinae Plane Block for Acute Back Pain in the Emergency Department

Обзор

The goal of this clinical trial is to learn if an erector spinae plane block (ESPB; a type of nerve block) works to reduce pain in adults presenting to the emergency department with low back pain. It will also learn if the ESPB reduces pain, disability, and return to work at 7 days. The main questions it aims to answer are: 1. Does the ESPB reduce short-term pain in participants with low back pain? 2. Does the ESPB reduce longer-term pain, reduce disability, and improve return to work and activities in participants with low back pain? Researchers will compare ESPB to a placebo (an injection that does not involve a nerve block) to see if ESPB works to treat low back pain. Participants will: Receive either the ESPB or a placebo injection in the emergency department Report their pain scores for up to 120 minutes Report their pain, disability, and return to work at 7 days

Вмешательства

• Процедура Erector Spinae Plane Block
  Erector Spinae Plane Block
• Процедура Sham Procedure
  Sham Procedure

Первичные конечные точки

• Pain score at 120 minutes post-intervention as assessed using a 10-point numeric rating scale [Срок оценки: Change from baseline to 120 minutes post-intervention]

Вторичные конечные точки (7)

• Pain score at 30 minutes post-intervention as assessed using a 10-point numeric rating scale [Срок оценки: Change from baseline to 30 minutes post-intervention]
• Pain score at 60 minutes post-intervention as assessed using a 10-point numeric rating scale [Срок оценки: Change from baseline to 60 minutes post-intervention]
• Degree of disability assessed via the Roland-Morris disability questionnaire at 7 days [Срок оценки: Assessed as the change in Roland-Morris disability questionnaire scores between baseline and 7 day follow up]
• Pain score at 7 days post-intervention as assessed using a 10-point numeric rating scale [Срок оценки: Pain score assessed at 7 days post-intervention]
• Opioid medications taken in the 7 days following the intervention [Срок оценки: Measured at 7 days post-intervention]
• Follow up visits related to low back pain in the 7 days following the intervention [Срок оценки: Assessed at 7 days]
• Return to work and activities assessed via the Work Productivity and Activity Impairment Questionnaire: General Health version 2.0 [Срок оценки: Assessed at 7 days]

Критерии участия

Критерии включения

• Adults (age ≥18 years) presenting to the emergency department with isolated low back pain present less than 6 total weeks.

Критерии исключения

• Do not speak English or Spanish as a primary language
• Are incarcerated
• Have a known pregnancy
• Are allergic to amide-type local anesthetics
• Are unable to tolerate positioning for the procedure
• Have a critical illness precluding the ability to perform the procedure.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Rush University Medical Center — Chicago

Идентификаторы

NCT: NCT06745453 · 24062802

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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