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

NCT ID: NCT06418841

Last Updated: 2024-05-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-28
• Study Completion Date: 2025-10-28

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Computer-Assisted Paramedian Approac Technique

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.

Group Type: EXPERIMENTAL

Computer-Assisted Paramedian Approach Technique

Intervention Type: PROCEDURE

Computer-Assisted Paramedian Approach Technique

Conventional Midline Approach Technique

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.

Group Type: EXPERIMENTAL

Conventional Midline Approach Technique

Intervention Type: PROCEDURE

Conventional Midline Approach Technique

Interventions

Computer-Assisted Paramedian Approach Technique

Computer-Assisted Paramedian Approach Technique

Intervention Type: PROCEDURE

Conventional Midline Approach Technique

Conventional Midline Approach Technique

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fujian Medical University Union Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Yuan-Dong Zhuang

Role: CONTACT

zyd2013@qq.com

15260866029

Other Identifiers

ChiCTR2300067936

Identifier Type: -

Identifier Source: org_study_id