Clinical trial NCT06418841: A Prospective Observational Study Comparing Computer-Assisted Paramedian Approach Versus Conventional Midline Approach for Lumbar Puncture
Official title: A Prospective Observational Study Comparing Computer-Assisted Paramedian Approach Versus Conventional Midline Approach for Lumbar Puncture
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Spinal Puncture
Keywords: computer modified paramedian approach technique, lumbar puncture, midline approach technique, puncture attempts, pain
Lead sponsor: Fujian Medical University Union Hospital
Sponsor class: OTHER
First posted: 2024-05-17
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Number of needle insertion attempts for successful LP
timeFrame: 30 minutes following treatment
Secondary outcomes:
measure: LP success rate
timeFrame: 30 minutes following treatment
measure: Assessment of back, head and leg pain using the NRS
timeFrame: before treatment, during surgery and 30 minutes,6 hours,1 days,3 days,7 days,2 weeks,4 weeks following treatment
measure: Adverse events and other unintended effects
timeFrame: during surgery and 30 minutes,6 hours,1 days,3 days,7 days,2 weeks,4 weeks following treatment
Other outcomes:
measure: Locating time
timeFrame: 30 minutes following treatment
measure: Puncture time
timeFrame: 30 minutes following treatment
measure: Evaluation from physician
timeFrame: 30 minutes following treatment
measure: Evaluation from patient
timeFrame: 30 minutes following treatment
Locations:
Study officials:
References: