An interventional study of Ultrasound-Assisted Lumbar Puncture and Standard Palpation-Guided Lumbar Puncture in Lumbar Puncture, sponsored by The Cooper Health System. Enrolling by invitation at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-17.
Sponsored by The Cooper Health System · Not applicable, Interventional, and Diagnostic
The goal of this randomized clinical trial is to determine whether ultrasound-assisted lumbar puncture improves first-needle insertion success compared with the standard palpation technique in adults undergoing a clinically indicated lumbar puncture.
The primary question is whether pre-procedural ultrasound localization increases the likelihood of successful cerebrospinal fluid collection on the first needle insertion. The study will also evaluate overall procedural success, the number of needle insertions and redirections, procedure time, the need for subsequent image-guided lumbar puncture, traumatic tap, procedural and post-procedural pain, and post-dural puncture headache.
Participants will be randomly assigned in a 1:1 ratio to undergo lumbar puncture using either pre-procedural ultrasound localization or standard palpation of anatomical landmarks.
Lumbar puncture (LP) is a commonly performed diagnostic and therapeutic procedure. The standard approach relies on palpation of surface anatomical landmarks to identify an appropriate intervertebral space for needle insertion. When landmarks are difficult to identify, LP may require multiple needle insertions or redirections, cause greater patient discomfort, delay cerebrospinal fluid (CSF) collection, or require a subsequent image-guided procedure.
Point-of-care ultrasound can be used before needle insertion to identify the spinal midline and an appropriate interspinous space and to estimate the depth to the target. Previous studies of ultrasound-assisted LP have produced variable findings regarding procedural success, efficiency, traumatic tap, and patient discomfort. Patient-centered complications, including post-dural puncture headache, have been less extensively evaluated.
This is a prospective, multicenter, parallel-group randomized controlled trial involving adults undergoing a clinically indicated LP in an inpatient or outpatient setting. Participants will be randomly assigned in a 1:1 ratio to pre-procedural ultrasound localization or standard palpation of anatomical landmarks.
In the ultrasound-assisted group, point-of-care ultrasound will be used before needle insertion to identify the spinal midline and interspinous space and estimate the depth to the target. The selected insertion site will then be marked, and the LP will proceed using standard technique; the needle will not be advanced under real-time ultrasound guidance. In the standard palpation group, the insertion site will be identified by palpation without pre-procedural ultrasound. Other aspects of the procedure and post-procedure care will follow standard clinical practice at each participating site.
The trial will determine whether pre-procedural ultrasound localization improves first-needle insertion success and reduces procedural burden and complications compared with standard palpation.
Exclusion Criteria:
Participants undergo pre-procedural point-of-care ultrasound to identify and mark the spinal midline, selected interspinous spaces and to estimate the depth to the target. The lumbar puncture is then performed using standard technique without real-time ultrasound guidance.
Procedure: Ultrasound-Assisted Lumbar Puncture
The lumbar puncture insertion site is selected by palpation of anatomical landmarks without pre-procedural ultrasound localization. The lumbar puncture is then performed using standard technique.
Other: Standard Palpation-Guided Lumbar Puncture
Pre-procedural point-of-care ultrasound is used to identify the midline, appropriate interspinous space, and estimated needle depth. The selected insertion site is marked, after which lumbar puncture is performed using standard sterile technique and institutional protocols.
Anatomical landmarks are identified by palpation of bony landmarks to select the lumbar puncture insertion site. Lumbar puncture is then performed using standard sterile technique and institutional protocols without pre-procedural ultrasound localization.
First Attempt Lumbar Puncture Success
First-attempt success is defined as successful cerebrospinal fluid (CSF) return following a single skin puncture, without complete withdrawal and reinsertion of the lumbar puncture needle. Up to three in-situ needle redirections are permitted. A redirection is defined as partial withdrawal and readvancement of the needle without removal from the skin.
Time frame: During the lumbar puncture procedure
Overall Lumbar Puncture Success
Successful CSF return during the initially assigned lumbar puncture procedure, regardless of the number of needle reinsertions or redirections and without requiring a subsequent fluoroscopy-guided lumbar puncture.
Time frame: During the initial lumbar puncture encounter
Number of Needle Reinsertions
Number of times the lumbar puncture needle is completely withdrawn from the skin and reinserted during the procedure.
Time frame: During the lumbar puncture procedure
Number of Needle Redirections
Number of times the needle is partially withdrawn and readvanced along a different trajectory without complete removal from the skin.
Time frame: During the lumbar puncture procedure
Procedure Time
Elapsed time in minutes from initiation of landmark identification using ultrasound or palpation until CSF return. For an unsuccessful procedure, time is measured until termination of the assigned bedside procedure.
Time frame: During the lumbar puncture procedure
Time to CSF Return
Time in minutes from the first skin puncture with the lumbar puncture needle to successful CSF return.
Time frame: During the lumbar puncture process
Incidence of Traumatic Tap
Proportion of participants with a traumatic lumbar puncture, defined as a CSF red blood cell count ≥400 cells/µL in the first collection tube with a decrease in red blood cell count in the fourth tube.
Time frame: During the lumbar puncture procedure
Incidence of Radicular Pain During Lumbar Puncture
Proportion of participants reporting radicular pain during the lumbar puncture procedure.
Time frame: During the lumbar puncture procedure
Post-Procedural Back Pain
Participant-reported pain at the lumbar puncture site, measured using a numeric rating scale from 0 to 10, with higher scores indicating greater pain.
Time frame: Within 24-48 hours after lumbar puncture
Incidence of Post-Dural Puncture Headache
Proportion of participants who develop a post-dural puncture headache meeting International Classification of Headache Disorders, Third Edition criteria.
Time frame: Within 5 days after lumbar puncture
Need for Fluoroscopic-Guided Lumbar Puncture
Proportion of participants requiring subsequent fluoroscopic-guided lumbar puncture after unsuccessful completion of the initially assigned lumbar puncture procedure.
Time frame: Within 7 days after the initial bedside lumbar puncture attempt
Hospitalization Related to Lumbar Puncture Complications
Hospitalization due to lumbar puncture-related complications, including prolonged hospitalization for inpatients or new hospital admission for outpatients.
Time frame: Within 1 month of lumbar puncture.
Plan to share: Yes — De-identified individual participant data underlying the results reported from this study may be made available to qualified researchers upon reasonable request, along with a data dictionary, subject to applicable institutional and regulatory requirements.
Supporting information: Study protocol
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