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

NCT07037992 | Not Yet Recruiting

• 1 other identifier: QLChronicNeuropathicPostOpPain
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain; Living Kidney Donor; Quadratus Lumborum Block; Laparoscopic Donor Nephrectomy

Outcome Measures

Primary Outcomes (11)

• Neuropathic Pain Incidence: Neuropathic Pain in 4 Questionnaire

  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

  3 months after intervention

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

  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)

  At 3 months after intervention

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

  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

  At 3 months after intervention

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

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

  At 3 months after intervention

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

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

  At 3 months after intervention

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

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

  At 3 months after intervention

• Neurophysiology Parameter: Mechanical Detection Threshold (MDt)

  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

  At 3 months after intervention

• Neurophysiology: Mechanical Pain Threshold (MPt)

  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

  At 3 months after intervention

• Neurophysiology Parameter: Pressure Pain Threshold (PPt)

  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

  At 3 months after intervention

• Neurophysiology Parameter: Mechanical Temporal Summation of Pain (MTSP)

  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

  At 3 months after intervention

• Neuromodulation Parameter: Serum Concentration of beta-Endorfin

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

  At 3 months after intervention

Study Arms (2)

Quadratus Lumborum Block

EXPERIMENTAL

Drug: injection of local anesthesia solution

Quadratus Lumborum Sham Block

PLACEBO COMPARATOR

Drug: Injection of normal saline

Interventions

injection of local anesthesia solution DRUG

Injection of 30 mL local anesthetic solution bupivacaine 0.25%

Quadratus Lumborum Block

Injection of normal saline DRUG

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

Quadratus Lumborum Sham Block

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

RSUPN Cipto Mangunkusumo

Jakarta Pusat, Jakarta Special Capital Region, 10430, Indonesia

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Raden B Sukmono

CONTACT

+628129508625; Raden.besthadi01@ui.ac.id

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist

Study Record Dates

• First Submitted: May 26, 2025
• First Posted: June 26, 2025
• Study Start: July 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: June 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)