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Recruiting NCT07397117

Comparing Ultrasound-Guided Transgluteal Nerve Block to Standard Care

No phase Interventional Sciatica Acute

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: nerve block with ropivacaine, Standard medical treatment.
Who it may be relevant to
Registry conditions: Sciatica Acute. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Comparing Ultrasound-Guided Transgluteal Nerve Block to Standard Care for Emergency Department Patients With Low Back Pain and Sciatic Radiculopathy: A Randomized Controlled Trial

Overview

The goal of this clinical trial is to compare transgluteal sciatic nerve block to standard of care to treat sciatic back pain in adult patients who present to the emergency department. The main question it aims to answer is: Is a transgluteal sciatic nerve block better than standard of care in improving pain in ER patients with sciatic back pain? If there is a comparison group: Researchers will compare patients who receive transgluteal sciatic nerve blocks to patients who receive standard of care to see if pain scores improve in ER patients with sciatic back pain. Participants will be randomized into the transgluteal sciatic nerve block group or the control group (standard of care). Participants will be asked to answer questions about their pain and will be asked to walk a timed short distance.

Interventions

  • Procedure nerve block with ropivacaine
    Ultrasound-guided transgluteal sciatic nerve block with 10-20 mL of 0.2% ropivacaine injected around the affected sciatic nerve at the level of the greater trochanter
  • Other Standard medical treatment
    Standard ED analgesic management per departmental protocols (oral/IV NSAIDs, acetaminophen, opioids, muscle relaxants).

Primary outcome measures

  • Pain scores [Time frame: 30 minutes after intervention, time of ED disposition (at decision point of admission to the hospital or discharge which can be up to 6 hours), 24 hours after ED visit, 48 hours after ED visit]
Secondary outcome measures (2)
  • Ambulatory status [Time frame: Before ED disposition, 24 and 48 hours after ED visit]
  • ED Bouncback [Time frame: 30 days after ED visit]

Eligibility criteria

Inclusion criteria

  • Adults aged 18 years and older
  • Presentation to ED with:
  • Acute or acute-on-chronic pain consistent with sciatica, defined as unilateral lumbosacral radicular pain radiating from the lower back or gluteal region to the posterior leg, may extend distal to the knee.
  • Pain score ≥ 5/10 on Numeric Rating Scale (NRS)

Exclusion criteria

  • Known allergy to study medications (e.g., local anesthetics)
  • Coagulopathy or current anticoagulation therapy
  • Suspected or confirmed spinal infection, or tumor
  • Neurological deficits (bowel or bladder dysfunction, leg weakness)
  • Inability to provide informed consent

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of California, San Francisco — San Francisco

Publications

  • Goldsmith AJ, Merz-Herrala J, Gullikson J, Selame LA, Cash RE, Martin D, Driver L, Schwimmer H, Shokoohi H, Duggan NM, Nagdev A. The Efficacy of Ultrasound-Guided Transgluteal Sciatic Nerve Blocks for Sciatic Radiculopathy Pain in the Emergency Department: A Multicenter Prospective Study. J Am Coll Emerg Physicians Open. 2025 Apr 10;6(3):100137. doi: 10.1016/j.acepjo.2025.100137. eCollection 2025 PMID 40256350

Identifiers

NCT: NCT07397117 · 25-44506

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗