Lumbar PunctureNCT07824284
Ultrasound-assisted vs Palpation-guided Lumbar Punctures
A study testing Ultrasound-Assisted Lumbar Puncture and Standard Palpation-Guided Lumbar Puncture in people with Lumbar Puncture, run by Cooper Norcross Health at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lumbar Puncture
- What is being tested?
- Ultrasound-Assisted Lumbar Puncture and Standard Palpation-Guided Lumbar Puncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 2 sitesUnited States
- Study dates
- 25 Apr 2026to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Cooper University Hospital
Camden, New Jersey, 08103
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Ultrasound-assisted vs. Standard Palpation Technique for Lumbar Puncture in Adults: A Randomized Controlled Trial of Procedural Success, Efficiency, and Complications
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.
Read the detailed description
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.
- Conditions
- Lumbar Puncture
- Being tested
- Ultrasound-Assisted Lumbar Puncture, Standard Palpation-Guided 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
- Medical subject headings
- Post-Dural Puncture Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-Assisted Lumbar PunctureProcedure or surgery
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 PunctureOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Standard Palpation-Guided Lumbar Puncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During the lumbar puncture procedure
Secondary outcomes (11)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: During the lumbar puncture procedure
Incidence of Radicular Pain During Lumbar Puncture
Proportion of participants reporting radicular pain during the lumbar puncture procedure.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Within 1 month of lumbar puncture.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study start25 Apr 2026
- Primary completionJun 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar PunctureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cooper Norcross Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Swarna Rajagopalan, Cooper Norcross Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07824284
- Sponsor's protocol ID
- 25-260
- Status last verified
- Sep 2026
- First submitted
- 2 Sep 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-assisted vs. Standard Palpation Technique for Lumbar Puncture in Adults: A Randomized Controlled Trial of Procedural Success, Efficiency, and Complications
- ClinicalTrials.gov ID
- NCT07824284
- Acronym / sponsor ID
- 25-260
- 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
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Cooper Norcross HealthUniversity, hospital or other
- Study start
- 25 Apr 2026 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 17 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound-assisted | Experimental | Procedure: Ultrasound-Assisted Lumbar PunctureParticipants 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. |
| Standard Palpation-Guided | Active comparator | Other: Standard Palpation-Guided Lumbar PunctureThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound-Assisted Lumbar PuncturePre-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. | Procedure or surgery | Ultrasound-assisted |
| Standard Palpation-Guided Lumbar PunctureAnatomical 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. | Other | Standard Palpation-Guided |
Primary outcome
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.
11 secondary outcomes
Overall Lumbar Puncture Success
Time frame: During the initial lumbar puncture encounter
Number of Needle Reinsertions
Time frame: During the lumbar puncture procedure
Number of Needle Redirections
Time frame: During the lumbar puncture procedure
Procedure Time
Time frame: During the lumbar puncture procedure
Time to CSF Return
Time frame: During the lumbar puncture process
Incidence of Traumatic Tap
Time frame: During the lumbar puncture procedure
Incidence of Radicular Pain During Lumbar Puncture
Time frame: During the lumbar puncture procedure
Post-Procedural Back Pain
Time frame: Within 24-48 hours after lumbar puncture
Incidence of Post-Dural Puncture Headache
Time frame: Within 5 days after lumbar puncture
Need for Fluoroscopic-Guided Lumbar Puncture
Time frame: Within 7 days after the initial bedside lumbar puncture attempt
Hospitalization Related to Lumbar Puncture Complications
Time frame: Within 1 month of lumbar puncture.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-Assisted Lumbar Puncture and Standard Palpation-Guided Lumbar Puncture in people with Lumbar Puncture, run by Cooper Norcross Health at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First Attempt Lumbar Puncture Success (time frame: During the lumbar puncture procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.