Spinal Puncture
Conditions
Keywords
computer modified paramedian approach technique, lumbar puncture, midline approach technique, puncture attempts, pain
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.
Interventions
PROCEDUREComputer-Assisted Paramedian Approach Technique
Computer-Assisted Paramedian Approach Technique
Conventional Midline Approach Technique
Sponsors
Fujian Medical University Union Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Locating time | 30 minutes following treatment | 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. |
| Puncture time | 30 minutes following treatment | 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. |
| Evaluation from physician | 30 minutes following treatment | The methods for assessing LP immediately after physician evaluation are categorised as follows: very good, good, average, bad and very bad. |
| Evaluation from patient | 30 minutes following treatment | Patient satisfaction, rated by patients immediately after LP, is classified as very good, good, average, bad or very bad. |
Contacts
Primary ContactYuan-Dong Zhuang
Outcome results
None listed