Ultrasound-assisted vs Palpation-guided Lumbar Punctures

NCT07824284 | Enrolling By Invitation

• 1 other identifier: 25-260
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Lumbar Puncture

Keywords

lumbar puncture; ultrasound-guided lumbar puncture; ultrasound-assisted lumbar puncture; point-of-care ultrasound; palpation-guided lumbar puncture; first-attempt success; post-dural puncture headache; multicenter; inpatient; outpatient

Outcome Measures

Primary Outcomes (1)

• 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.

  During the lumbar puncture procedure

Secondary Outcomes (11)

• Overall Lumbar Puncture Success

  During the initial lumbar puncture encounter

• Number of Needle Reinsertions

  During the lumbar puncture procedure

• Number of Needle Redirections

  During the lumbar puncture procedure

• Procedure Time

  During the lumbar puncture procedure

• Time to CSF Return

  During the lumbar puncture process

Study Arms (2)

Ultrasound-assisted

EXPERIMENTAL

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

Standard Palpation-Guided

ACTIVE COMPARATOR

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

Interventions

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.

Ultrasound-assisted

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.

Standard Palpation-Guided

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cooper Health System: lead

Study Sites (2)

Cooper University Hospital

Camden, New Jersey, 08103, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Post-Dural Puncture Headache

Condition Hierarchy (Ancestors)

Headache Disorders, Secondary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Neurology, Attending Physician, Neurocritical Care, Principal Investigator

Study Record Dates

• First Submitted: September 2, 2026
• First Posted: September 17, 2026
• Study Start: April 25, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: September 17, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

US (2)