- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07397117
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
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Tianyu Tang, MD
- Phone Number: 628-247-7578
- Email: tianyu.tang@ucsf.edu
Study Contact Backup
- Name: Felipe Ocampo, MD
- Email: felipe.ocampo@ucsf.edu
Study Locations
-
-
California
-
San Francisco, California, United States, 94107
- Recruiting
- University of California, San Francisco
-
Contact:
- Tianyu Tang, MD
- Phone Number: 628-247-7578
- Email: tianyu.tang@ucsf.edu
-
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
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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
Investigators
- Principal Investigator: Jeanne Noble, MD, University of California, San Francisco
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Nervous System Diseases
- Neuromuscular Diseases
- Peripheral Nervous System Diseases
- Neuralgia
- Mononeuropathies
- Sciatic Neuropathy
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Radiculopathy
- Sciatica
- Organic Chemicals
- Surgical Procedures, Operative
- Anilides
- Amides
- Aniline Compounds
- Amines
- Anesthesia and Analgesia
- Neurosurgical Procedures
- Anesthesia, Conduction
- Anesthesia
- Denervation
- Ropivacaine
- Nerve Block
Other Study ID Numbers
- 25-44506
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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