A Prospective Observational Study Comparing Computer-Assisted Paramedian Approach Versus Conventional Midline Approach for Lumbar Puncture

NCT06418841 | Not Yet Recruiting

• 1 other identifier: ChiCTR2300067936
• Study Type: interventional
• Target: 84
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical trial is to compare the effects of CMPAT and MAT in patients undergoing LP. Participants will be randomly assigned to either the CMPAT treatment group (group A) or the MAT treatment group (group B). Researchers will compare CMPAT treatment group and the MAT treatment group to see if the number of needle insertion attempts required for a successful LP, the puncture success rate, pain assessment in the back, head, and legs, and the occurrence of complications have different.

Conditions

Spinal Puncture

Keywords

computer modified paramedian approach technique, lumbar puncture, midline approach technique, puncture attempts, pain

Outcome Measures

Primary Outcomes (1)

• Number of needle insertion attempts for successful LP

  A successful puncture was defined as the presence of CSF outflow from the puncture needle. The number of needle insertion attempts was determined by the number of times the puncture needle was inserted into the target area.

  30 minutes following treatment

Secondary Outcomes (3)

• LP success rate

  30 minutes following treatment

• Assessment of back, head and leg pain using the NRS

  before treatment, during surgery and 30 minutes,6 hours,1 days,3 days,7 days,2 weeks,4 weeks following treatment

• Adverse events and other unintended effects

  during surgery and 30 minutes,6 hours,1 days,3 days,7 days,2 weeks,4 weeks following treatment

Other Outcomes (4)

• Locating time

  30 minutes following treatment

• Puncture time

  30 minutes following treatment

• Evaluation from physician

  30 minutes following treatment

Study Arms (2)

Computer-Assisted Paramedian Approac Technique

EXPERIMENTAL

The L3-4 inter-laminar space will be selected as the target for puncture, and in the longitudinal direction, 1.0-1.5cm will be opened beside the upper edge of the spinous process (tip) of the lower vertebra as the entry point. The lumbar puncture needle will be inserted vertically along the axis of the anesthesia needle. The puncture path will be maintained completely perpendicular to the skin until the needle reached the PLTLF (posterior layer of the thoracolumbar fascia), where some resistance will be felt. The puncture direction is adjusted as needed. The tip of the needle will be tilted 20±10° in the sagittal direction and 15±5° inward such that the tip will point at the midpoint of the spinal canal. After the needle reaches the PLTLF, it will be further inserted 3-7 cm.

Procedure: Computer-Assisted Paramedian Approach Technique

Conventional Midline Approach Technique

EXPERIMENTAL

Puncture will be performed on the posterior median line near the midpoint of the L3-4 Space of spinous process. The lumbar puncture needle will be inserted vertically along the axis of the anesthesia needle, or the tip of the needle will be tilted 15° in the sagittal direction toward the head, so that the needle path is parallel to the space of spinous process.

Procedure: Conventional Midline Approach Technique

Interventions

Computer-Assisted Paramedian Approach Technique PROCEDURE

Computer-Assisted Paramedian Approach Technique

Computer-Assisted Paramedian Approac Technique

Conventional Midline Approach Technique PROCEDURE

Conventional Midline Approach Technique

Conventional Midline Approach Technique

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18-99 years. Indication for lumber puncture (diagnostic lumbar puncture, analysis of cerebrospinal fluid composition, measurement of cerebrospinal fluid pressure, release of cerebrospinal fluid, lumbar cistern drain-age or intrathecal injection).
• Body mass index between 18.5 and 35 kg/m2.

You may not qualify if:

• Cerebral hernia or known high cerebrospinal fluid pressure prone to cerebral hernia.
• Oral anticoagulant or antiplatelet therapy (≤3 days) or coagulation dysfunction, various factors lead to a higher risk of bleeding.
• Active infection or prior infection at the surgical site.
• Skin breakdown.
• Previous spine fusion surgery.
• Cauda equina syndrome.
• Pregnancy or breast feeding.
• Severe comorbid medical or psychiatric disorder.
• Unwilling to adhere to any of the required procedures.
• Cognitive impairment interfering with participant's ability to give full and - - informed consent or complete the baseline or follow-up assessments.
• Survival expectation less than 1 month.
• Moving abroad in 1 month.

Sponsors & Collaborators

• Fujian Medical University Union Hospital: lead

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Yuan-Dong Zhuang

CONTACT

15260866029; zyd2013@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2024
• First Posted: May 17, 2024
• Study Start: October 28, 2024
• Primary Completion: October 28, 2025
• Study Completion: October 28, 2025
• Last Updated: May 17, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share