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Enrolling by invitation

NCT Number: NCT07824284

Ultrasound-assisted vs Palpation-guided Lumbar Punctures

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.

Enrolling by invitation

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cooper University Hospital, Camden, New Jersey, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults aged 18 years old and above
  • Patients requiring lumbar puncture for diagnostic or therapeutic purposes as determined by the treating physician
  • Must be able to give informed consent, or if unable, have a legally authorized representative provide written consent

Exclusion criteria

  • Inability to safely undergo bedside lumbar puncture (either ultrasound-guided or palpation guided) as determined by the treating physician
  • Known contraindications to lumbar puncture, including:
  • Increased intracranial pressure with risk of herniation
  • Infection at the lumbar puncture site
  • Known coagulopathy or platelet count <50,000 µL
  • Received DVT prophylaxis on the day of planned lumbar puncture

Treatment and study plan

Ultrasound-Assisted Lumbar Puncture

Procedure

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.

Standard Palpation-Guided Lumbar Puncture

Other

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.

Primary outcomes

  1. First Attempt Lumbar Puncture Success

    Time frame: During the lumbar puncture procedure

    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.

Secondary outcomes

  1. Overall Lumbar Puncture Success

    Time frame: During the initial lumbar puncture encounter

    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.

  2. Number of Needle Reinsertions

    Time frame: During the lumbar puncture procedure

    Number of times the lumbar puncture needle is completely withdrawn from the skin and reinserted during the procedure.

  3. Number of Needle Redirections

    Time frame: During the lumbar puncture procedure

    Number of times the needle is partially withdrawn and readvanced along a different trajectory without complete removal from the skin.

  4. Procedure Time

    Time frame: During the lumbar puncture procedure

    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.

  5. Time to CSF Return

    Time frame: During the lumbar puncture process

    Time in minutes from the first skin puncture with the lumbar puncture needle to successful CSF return.

  6. Incidence of Traumatic Tap

    Time frame: During the lumbar puncture procedure

    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.

  7. Incidence of Radicular Pain During Lumbar Puncture

    Time frame: During the lumbar puncture procedure

    Proportion of participants reporting radicular pain during the lumbar puncture procedure.

  8. Post-Procedural Back Pain

    Time frame: Within 24-48 hours after lumbar puncture

    Participant-reported pain at the lumbar puncture site, measured using a numeric rating scale from 0 to 10, with higher scores indicating greater pain.

  9. Incidence of Post-Dural Puncture Headache

    Time frame: Within 5 days after lumbar puncture

    Proportion of participants who develop a post-dural puncture headache meeting International Classification of Headache Disorders, Third Edition criteria.

  10. Need for Fluoroscopic-Guided Lumbar Puncture

    Time frame: Within 7 days after the initial bedside lumbar puncture attempt

    Proportion of participants requiring subsequent fluoroscopic-guided lumbar puncture after unsuccessful completion of the initially assigned lumbar puncture procedure.

  11. Hospitalization Related to Lumbar Puncture Complications

    Time frame: Within 1 month of lumbar puncture.

    Hospitalization due to lumbar puncture-related complications, including prolonged hospitalization for inpatients or new hospital admission for outpatients.

Sponsors and collaborators

Lead sponsor

The Cooper Health System

Other

Registry information

Official study title

Ultrasound-assisted vs. Standard Palpation Technique for Lumbar Puncture in Adults: A Randomized Controlled Trial of Procedural Success, Efficiency, and Complications

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Sep 17, 2026
Registry last updated
Sep 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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