A Prospective Observational Study Comparing Computer-Assisted Paramedian Approach Versus Conventional Midline Approach for Lumbar Puncture
- Conditions
- Spinal Puncture
- Registration Number
- NCT06418841
- Lead Sponsor
- Fujian Medical University Union Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 84
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Number of needle insertion attempts for successful LP 30 minutes following treatment 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.
- Secondary Outcome Measures
Name Time Method 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 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.
LP success rate 30 minutes following treatment 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.
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 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.