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
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
干预措施: Injection of normal saline (Drug)
Quadratus Lumborum Block
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
Raden Besthadi Sukmono
Anesthesiologist
Indonesia University
