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

Spinal Puncture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06418841
• Other study ID #: ChiCTR2300067936
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 28, 2024
• Est. completion date: October 28, 2025

Study information

• Verified date: February 2024
• Source: Fujian Medical University Union Hospital
• Contact: Yuan-Dong Zhuang
• Phone: 15260866029
• Email: zyd2013[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 84
• Est. completion date: October 28, 2025
• Est. primary completion date: October 28, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Spinal Puncture
• Wounds and Injuries

Intervention

Procedure:
• Computer-Assisted Paramedian Approach Technique
Computer-Assisted Paramedian Approach Technique
• Conventional Midline Approach Technique
Conventional Midline Approach Technique

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fujian Medical University Union Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Primary	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	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
Secondary	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
Secondary	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