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

May 29, 2026 updated by: University of California, San Francisco

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

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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
Active Comparator: Standard of care
Standard ED analgesic management per departmental protocols (oral/IV NSAIDs, acetaminophen, opioids, muscle relaxants).
Other: Standard medical treatment
Standard ED analgesic management per departmental protocols (oral/IV NSAIDs, acetaminophen, opioids, muscle relaxants).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of California, San Francisco

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 26, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 25, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 5, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 9, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 29, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 25-44506

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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