Comparing Ultrasound-Guided Transgluteal Nerve Block to Standard Care
ConditionSciatica Acute
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, San Francisco
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 18 years and older
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)
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
nerve block with ropivacaine
Procedure/SurgeryUltrasound-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
Standard medical treatment
Other interventionStandard ED analgesic management per departmental protocols (oral/IV NSAIDs, acetaminophen, opioids, muscle relaxants).
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Transgluteal sciatic nerve blockExperimental treatment 1 intervention
Group B: Standard of careActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Pain scores
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
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 visitSecondary outcomes
1
Ambulatory status
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.
Time frame
Before ED disposition, 24 and 48 hours after ED visit2
ED Bouncback
A chart review will be performed after 30 days to assess bounce-back rate
Time frame
30 days after ED visitSponsors and contacts
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Source ClinicalTrials.gov