Chronic PainNCT07037992
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
A study testing injection of local anesthesia solution and Injection of normal saline in people with Chronic Pain and Living Kidney Donor, run by Universitas Indonesia at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Pain, Living Kidney Donor, Quadratus Lumborum Block
- What is being tested?
- injection of local anesthesia solution and Injection of normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Nov 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Living kidney donor candidate patients aged 18-65 years Patients with ASA physical status assessment 1-3 Patients are willing to be research subjects.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
RSUPN Cipto Mangunkusumo
Jakarta Pusat, Jakarta Special Capital Region, 10430
About this study
Official 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
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
- Being tested
- injection of local anesthesia solution, Injection of normal saline
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
injection of local anesthesia solutionDrug
Injection of 30 mL local anesthetic solution bupivacaine 0.25%
Injection of normal salineDrug
Injection of 30 mL normal saline Natrium Chloride (NaCl) 0.9%
| Study group | Role | What they receive |
|---|---|---|
| Quadratus Lumborum Block | Experimental | Not described Receives: Drug: injection of local anesthesia solution |
| Quadratus Lumborum Sham Block | Placebo comparator | Not described Receives: Drug: Injection of normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
- Mild (NRS 1-3)
- Moderate (NRS 4-6)
- Severe (NRS 7-10)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: At 3 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2025
- Study start1 Nov 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raden Besthadi Sukmono, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07037992
- Sponsor's protocol ID
- QLChronicNeuropathicPostOpPain
- Status last verified
- Jul 2026
- First submitted
- 26 May 2025
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07037992
- Acronym / sponsor ID
- QLChronicNeuropathicPostOpPain
- Conditions
- Chronic Pain, Living Kidney Donor, Quadratus Lumborum Block, Laparoscopic Donor Nephrectomy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 26 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Quadratus Lumborum Block | Experimental | Drug: injection of local anesthesia solution |
| Quadratus Lumborum Sham Block | Placebo comparator | Drug: Injection of normal saline |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Living kidney donor candidate patients aged 18-65 years Patients with ASA physical status assessment 1-3 Patients are willing to be research subjects.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| injection of local anesthesia solutionInjection of 30 mL local anesthetic solution bupivacaine 0.25% | Drug | Quadratus Lumborum Block |
| Injection of normal salineInjection of 30 mL normal saline Natrium Chloride (NaCl) 0.9% | Drug | Quadratus Lumborum Sham Block |
Primary outcome
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
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 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
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
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
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
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
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
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
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing injection of local anesthesia solution and Injection of normal saline in people with Chronic Pain and Living Kidney Donor, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuropathic Pain Incidence: Neuropathic Pain in 4 Questionnaire (time frame: 3 months after intervention). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.