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NCT Number: NCT07037992

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

RSUPN Cipto Mangunkusumo

Jakarta Pusat, Jakarta Special Capital Region, 10430, Indonesia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

injection of local anesthesia solution

Drug

Injection of 30 mL local anesthetic solution bupivacaine 0.25%

Injection of normal saline

Drug

Injection of 30 mL normal saline Natrium Chloride (NaCl) 0.9%

Primary outcomes

  1. Neuropathic Pain Incidence: Neuropathic Pain in 4 Questionnaire

    Time frame: 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

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

    Time frame: 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

    • Mild (NRS 1-3)
    • Moderate (NRS 4-6)
    • Severe (NRS 7-10)
  3. Chronic Pain Severity: Leeds Assesment of neuropathic symptoms and sign (LANSS) scale

    Time frame: 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

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

    Time frame: At 3 months after intervention

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

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

    Time frame: At 3 months after intervention

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

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

    Time frame: At 3 months after intervention

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

  7. Neurophysiology Parameter: Mechanical Detection Threshold (MDt)

    Time frame: 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

  8. Neurophysiology: Mechanical Pain Threshold (MPt)

    Time frame: 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

  9. Neurophysiology Parameter: Pressure Pain Threshold (PPt)

    Time frame: 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

  10. Neurophysiology Parameter: Mechanical Temporal Summation of Pain (MTSP)

    Time frame: 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

  11. Neuromodulation Parameter: Serum Concentration of beta-Endorfin

    Time frame: At 3 months after intervention

    Neuropeptide produced in the anterior pituitary and brain, as an endogenous opioid.

    Units: pg/mL

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 26, 2025
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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