Comparing Ultrasound-Guided Transgluteal Nerve Block to Standard Care (TGSNB vs SoC)

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

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.

Study Overview

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • California
      • San Francisco, California, United States, 94107
        • Recruiting
        • University of California, San Francisco
        • Contact:
        • Sub-Investigator:
          • Kavita Gandhi, MD
        • Sub-Investigator:
          • Nancy Anaya, MD
        • Sub-Investigator:
          • Jeffrey Merz-Herrala, MD
        • Sub-Investigator:
          • Tianyu Tang, MD
        • Sub-Investigator:
          • Felipe Ocampo, MD
        • Principal Investigator:
          • Jeanne Noble, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Transgluteal sciatic nerve block
Patients will receive an 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.
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
Active Comparator: Standard of care
Standard ED analgesic management per departmental protocols (oral/IV NSAIDs, acetaminophen, opioids, muscle relaxants).
Standard ED analgesic management per departmental protocols (oral/IV NSAIDs, acetaminophen, opioids, muscle relaxants).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Patients in each group will be asked their pain score 30 minutes after their received intervention and at time of ED disposition (at decision point of admission to the hospital or discharge which can be up to 6 hours). Patients will then be contacted 24 and 48 hours after intervention to ask their pain score
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

Outcome Measure
Measure Description
Time Frame
Ambulatory status
Time Frame: Before ED disposition, 24 and 48 hours after ED visit
Before ED disposition, patients will be asked to perform another timed up and go (TUG) test. A patient rises from a chair, walks at a normal pace to a line (3 meters total), turns, walks back, and sits down. Patients will then be contacted 24 and 48 hours after intervention to ask about how their ambulatory status is.
Before ED disposition, 24 and 48 hours after ED visit
ED Bouncback
Time Frame: 30 days after ED visit
A chart review will be performed after 30 days to assess bounce-back rate
30 days after ED visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Jeanne Noble, MD, University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 26, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

January 31, 2027

Study Registration Dates

First Submitted

January 25, 2026

First Submitted That Met QC Criteria

February 5, 2026

First Posted (Actual)

February 9, 2026

Study Record Updates

Last Update Posted (Actual)

June 2, 2026

Last Update Submitted That Met QC Criteria

May 29, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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