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

Not Applicable

Not yet recruiting

• Conditions: Chronic Pain; Living Kidney Donor; Quadratus Lumborum Block; Laparoscopic Donor Nephrectomy
• Interventions: Drug: injection of local anesthesia solution; Drug: Injection of normal saline

• Registration Number: NCT07037992
• Lead Sponsor: Indonesia University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-05-26
• Status Verified: 2025-06
• Study First Submitted QC: 2025-06-17
• Last Update Submitted: 2025-06-17
• Study First Posted: 2025-06-26
• Last Update Posted: 2025-06-26
• Study Start: 2025-07-01
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Quadratus Lumborum Block	injection of local anesthesia solution	-
Quadratus Lumborum Sham Block	Injection of normal saline	-

Primary Outcome Measures

Name	Time	Method
Neuropathic Pain Incidence: Neuropathic Pain in 4 Questionnaire	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)	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	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)	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)	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)	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)	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)	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)	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)	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	At 3 months after intervention	Neuropeptide produced in the anterior pituitary and brain, as an endogenous opioid.; Units: pg/mL

Trial Locations

Locations (1)

RSUPN Cipto Mangunkusumo; 🇮🇩 Jakarta Pusat, Jakarta, Indonesia