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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Spinal Puncture
• Intervention / Treatment: Procedure: Conventional Midline Approach Technique; Procedure: Computer-Assisted Paramedian Approach Technique

• Study Type: Interventional
• Enrollment (Estimated): 84
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yuan-Dong Zhuang; Phone Number: 15260866029; Email: zyd2013@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: Conventional Midline Approach Technique; Conventional Midline Approach Technique
Experimental: 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.	Procedure: Computer-Assisted Paramedian Approach Technique; Computer-Assisted Paramedian Approach Technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
LP success rate	The parameters will measure the success rate of puncture in one attempt, the success rate of puncture within three attempts and the success rate of puncture within six attempts.	30 minutes following treatment
Assessment of back, head and leg pain using the NRS	In the NRS, patients will be asked to indicate a number ranging from 0 to 10, which best reflects the intensity of their pain. A score of 0 indicates the absence of pain, while a score of 10 signifies the most excruciating pain imaginable. The NRS will be used to assess the severity of localised back pain, headaches, leg pain and numbness experienced by patients after LP.	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	This study will monitor all adverse events during and after trial interventions, followed by causality assessment. In addition to risk mitigation protocols, we will remain vigilant about rare potential complications including drug allergies during anaesthesia; adjacent organ/ tissue injury; nerve, vascular or organ damage; paralysis, shock; difficulties/failures in puncture; needle breakage; persistent pain; neurological impairment; infections; CSF leakage; wound healing issues; epidural haematoma, etc. Their likelihood is extremely low under specialised surgical expertise.Any undesirable medical condition will be documented and reported transparently per ethics guidelines. The data safety monitoring board may recommend modifying/stopping the trial if safety concerns emerge. We will ensure diligent surveillance and injury precautions to safeguard participants.	during surgery and 30 minutes,6 hours,1 days,3 days,7 days,2 weeks,4 weeks following treatment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Locating time	The time taken to locate and mark the patient, defined as the duration from the beginning of positioning till the insertion of the anaesthetic needle.	30 minutes following treatment
Puncture time	The time taken to perform the LP defined as the duration from the first insertion of the puncture needle till the beginning of the outflow of CSF from the puncture needle.	30 minutes following treatment
Evaluation from physician	The methods for assessing LP immediately after physician evaluation are categorised as follows: very good, good, average, bad and very bad.	30 minutes following treatment
Evaluation from patient	Patient satisfaction, rated by patients immediately after LP, is classified as very good, good, average, bad or very bad.	30 minutes following treatment

Collaborators and Investigators

• Sponsor: Fujian Medical University Union Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): October 28, 2024
• Primary Completion (Estimated): October 28, 2025
• Study Completion (Estimated): October 28, 2025

Study Registration Dates

• First Submitted: May 14, 2024
• First Submitted That Met QC Criteria: May 14, 2024
• First Posted (Actual): May 17, 2024

Study Record Updates

• Last Update Posted (Actual): May 17, 2024
• Last Update Submitted That Met QC Criteria: May 14, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: computer modified paramedian approach technique, lumbar puncture, midline approach technique, puncture attempts, pain
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: ChiCTR2300067936

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No