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临床试验/NCT07037992
NCT07037992进行中(未招募)不适用

The Effect of Subcostal Anterior Quadratus Lumborum Block on the Incidence of Chronic Neuropathic Pain After Retroperitoneal Laparoscopic Donor Nephrectomy: A Study on Neuroinflammation and Neurophysiology

Indonesia University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年11月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
60
试验地点
1
主要终点
Neuropathic Pain Incidence: Neuropathic Pain in 4 Questionnaire

研究概览

简要总结

To analyze the relationship of anterior subcostal quadratus lumborum (QL) block compared with control block on the incidence of chronic neuropathic pain at three months post-laparoscopic retroperitoneal living kidney donor.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Living kidney donor candidate patients aged 18-65 years Patients with ASA physical status assessment 1-3 Patients are willing to be research subjects.

排除标准

  • •The patient was known to have a history of chronic non-cancer pain and cancer pain.
  • •The patient had a history of preoperative laparoscopic kidney donor surgery.

研究组 & 干预措施

Quadratus Lumborum Sham Block

Placebo Comparator

干预措施: Injection of normal saline (Drug)

Quadratus Lumborum Block

Experimental

干预措施: injection of local anesthesia solution (Drug)

结局指标

主要结局

Neuropathic Pain Incidence: Neuropathic Pain in 4 Questionnaire

时间窗: 3 months after intervention

Pain that develops after a surgical procedure in the area of surgery and its radiation, persists for at least 3 months after surgery, other causes of pain (e.g. infection and history of malignancy) or pre-existing pain have been excluded. Total score: 10 Score ≤ 4 = no pain developed Score ≥ 4 = pain developed

Neuromodulation Parameter: Degree of functional interference using Behavioral Pain Interference (BPI)

时间窗: At 3 months after intervention

The degree of pain that develops after a surgical procedure in the area of surgery and its radiation, persisting for at least 3 months after surgery, other causes of pain (eg infection and history of malignancy) or pre-existing pain have been excluded. Behavioral Pain Interference (BPI) questionnaire based on the average of questions 4, 5, and 6 1. Mild (NRS 1-3) 2. Moderate (NRS 4-6) 3. Severe (NRS 7-10)

Chronic Pain Severity: Leeds Assesment of neuropathic symptoms and sign (LANSS) scale

时间窗: At 3 months after intervention

A measuring tool used to assess neuropathic pain and provides information to differentiate nociceptive pain from neuropathic pain. Total score: 24 \<12: Not neuropathic \>12: Neuropathic pain

Neuroinflammation Parameter: Serum Concentration of Toll-like Receptor 4 (TLR4)

时间窗: At 3 months after intervention

Transmembrane receptors in the innate immune system. Units: ng/mL

Neuroinflammation Parameter: Serum Concentration of Calcitonin gene-related peptide (CGRP)

时间窗: At 3 months after intervention

Neuropeptides that play a role in pain transmission and vasodilation Unit: pg/mL

Neuroinflammation Parameter: Serum Concentration of Nerve Growth Factor (NGF)

时间窗: At 3 months after intervention

Neurotrophic factors that play a role in promoting the growth and survival of sensory neurons Unit: pg/mL

Neurophysiology Parameter: Mechanical Detection Threshold (MDt)

时间窗: At 3 months after intervention

Measures the minimum force needed for a person to perceive a light mechanical stimulus, tested using von Frey filaments. Skin contact test for 2 seconds using 1 set of von Frey filaments. The examination is performed in m. trapezius. Unit: mN Lower result means: higher sensitivity (normal or hypersensitivity) Higher result means: Reduced sensitivity, could indicate hypoesthesia or nerve damage

Neurophysiology: Mechanical Pain Threshold (MPt)

时间窗: At 3 months after intervention

Accurate measurement of pain threshold. Skin contact test using repeated pinpricks at the same location. Comparative assessment of initial pain scale with pain scale after repeated stimulation. Examination is performed at m. trapezius. Unit: Numerical Rating Scale (NRS) from 1 to 10 Lower NRS: higher sensitivity to pain Higher NRS: lower sensitivity to pain

Neurophysiology Parameter: Pressure Pain Threshold (PPt)

时间窗: At 3 months after intervention

Pain tolerance examination. Pressure assessment in kgf/cm2 units where the patient complains of pain according to the stimulus given. The examination is carried out in m. trapezius Units: kgf/cm2. Lower PPT: Increased pain sensitivity Higher PPT: Decreased pain sensitivity

Neurophysiology Parameter: Mechanical Temporal Summation of Pain (MTSP)

时间窗: At 3 months after intervention

Evaluates central sensitization by applying repeated light mechanical stimuli and rating how pain builds up over time. Pressure assessment in kgf/cm2 units where the patient complains of pain according to the stimulus given. The examination is carried out in m. trapezius. Units: Verbal Numeric Scale (VNS) from 1 to 10 Higher MTSP score: Indicates central sensitization Lower MTSP score: Normal pain processing

Neuromodulation Parameter: Serum Concentration of beta-Endorfin

时间窗: At 3 months after intervention

Neuropeptide produced in the anterior pituitary and brain, as an endogenous opioid. Units: pg/mL

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Raden Besthadi Sukmono

Anesthesiologist

Indonesia University

研究点 (1)

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