Department of Neurosurgery, Fujian Medical University Union Hospital, Fuzhou, Fujian, China.
Fujian Medical University, Fuzhou, Fujian, China.
BMJ Open. 2024 Feb 20;14(2):e077941. doi: 10.1136/bmjopen-2023-077941.
The lumbar puncture (LP) technique is widely used for diagnostic and therapeutic purposes. In recent years, the paramedian approach technique (PAT) has gained increasing interest due to its advantages over the conventional midline approach technique (MAT) that has been traditionally employed in clinical practice for LP. However, there have been inconsistent discussions regarding the efficacy of different LP techniques. Based on digital virtual human and computer simulation techniques, a new approach called computerised modified PAT (CMPAT) was proposed. Therefore, the aim of this study is to discuss a randomised controlled trial (RCT) protocol to investigate and compare the effects of CMPAT and MAT in patients undergoing LP.
We will conduct a prospective, multicentre RCT. The study will recruit 84 patients aged 18-99 years who require LP. Participants will be randomly assigned to either the CMPAT treatment group (group A) or the MAT treatment group (group B). The primary outcome measure will be the number of needle insertion attempts required for a successful LP. Secondary outcomes will include the puncture success rate, pain assessment in the back, head, and legs, and the occurrence of complications. The measurement of these secondary outcomes will be taken during the procedure, as well as at specific time points: 30 min, 6 hours, 1 day, 3 days, 7 days, 2 weeks and 4 weeks after the procedure. Pain levels will be assessed using a Numerical Rating Scale.
Ethical approval (2022YF052-01) has been obtained from the Ethics Committee of Fujian Medical University Union Hospital, Fuzhou, China. The research findings will be published in an international peer-reviewed scientific journal and presented at scientific conferences.
ChiCTR2300067937.
腰椎穿刺（LP）技术广泛应用于诊断和治疗目的。近年来，旁正中入路技术（PAT）因其优于传统临床实践中使用的正中入路技术（MAT）的优势而受到越来越多的关注。然而，对于不同 LP 技术的疗效存在不一致的讨论。基于数字虚拟人和计算机模拟技术，提出了一种新的方法，称为计算机化改良 PAT（CMPAT）。因此，本研究旨在讨论一项随机对照试验（RCT）方案，以调查和比较 CMPAT 和 MAT 在接受 LP 的患者中的效果。
我们将进行一项前瞻性、多中心 RCT。该研究将招募 84 名 18-99 岁需要 LP 的患者。参与者将被随机分配到 CMPAT 治疗组（A 组）或 MAT 治疗组（B 组）。主要结局指标将是成功 LP 所需的针插入尝试次数。次要结局包括穿刺成功率、背部、头部和腿部疼痛评估以及并发症的发生。这些次要结局的测量将在手术过程中以及特定时间点进行：术后 30 分钟、6 小时、1 天、3 天、7 天、2 周和 4 周。疼痛程度将使用数字评分量表进行评估。
已获得中国福州福建医科大学附属协和医院伦理委员会的伦理批准（2022YF052-01）。研究结果将发表在国际同行评议的科学期刊上，并在科学会议上展示。
ChiCTR2300067937。
