Laparoscopic Donor NephrectomyNCT06764667
Comparison of Spinal Anesthesia Adjuvant and Quadratus Lumborum Block on the Opioid Requirement and Perioperative Pain of Laparoscopic Kidney Transplant Donor
A study testing Spinal anesthesia adjuvant, Quadratus Lumborum Block (QLB) and General Anesthesia in people with Laparoscopic Donor Nephrectomy and Perioperative Pain Management, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
This study aims to compare the effectiveness of spinal anesthesia adjuvant and quadratus lumborum block on the opioid requirement and perioperative pain on patients undergoing laparoscopic kidney transplant donor. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Laparoscopic Donor Nephrectomy, Perioperative Pain Management
- What is being tested?
- Spinal anesthesia adjuvant, Quadratus Lumborum Block (QLB) and General Anesthesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIndonesia
- Study dates
- 10 Feb 2025to 31 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18-65 years undergoing laparoscopic donor nephrectomy
- Patients with BMI ≤ 35 kg/m2
- Patients with American Society of Anesthesiology (ASA) physical status 1-2
- Patients who are willing to participate in this study
Who cannot join
- Cardiovascular disease (uncontrolled stage 2 hypertension, heart failure, arrhytmia)
- Recent onset cerebrovascular diseasae of < 3 months
- Infection on spinal site
- Coagulopathy
- Elevated intracranial pressure
- Severe renal or liver dysfunction
- Valvular heart disease or atrioventricular block
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
RSUP dr. Cipto Mangunkusumo
Jakarta Pusat, Jakarta Special Capital Region, 10430
About this study
This study aims to compare the effectiveness of spinal anesthesia adjuvant and quadratus lumborum block on the opioid requirement and perioperative pain on patients undergoing laparoscopic kidney transplant donor.
- Being tested
- Spinal anesthesia adjuvant, Quadratus Lumborum Block (QLB), General Anesthesia
- Keywords
- Quadratus lumborum block, Spinal anesthesia adjuvant, Laparoscopic donor nephrectomy, Perioperative pain management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal anesthesia adjuvantProcedure or surgery
Patients in this arm will receive 10 mg 0.5% hyperbaric Bupivacaine, 100 mcg Morphine, 100 mcg Sulfas Atropine, and 0.9% normal saline to total volume of 4 ml before induction of anesthesia.
Quadratus Lumborum Block (QLB)Procedure or surgery
Patients in this arm will receive quadratus lumborum block with 20-30 ml of 0.25% Bupivacaine after induction of anesthesia and after operation.
General AnesthesiaProcedure or surgery
The subject will undergo preoxygenation with 100% oxygen for 3 minutes. Following preoxygenation, anesthesia induction will be performed using lidocaine at a dose of 1.5 mg/kg, fentanyl at 1.5 mcg/kg, and propofol at 2.0 mg/kg. Once the subject is adequately sedated, baseline neuromuscular monitoring using the train-of-four (TOF) technique will be conducted, followed by the administration of rocuronium at a dose of 0.8 mg/kg. Endotracheal intubation will be performed using direct laryngoscopy once the TOF value reaches 0, utilizing an appropriately sized endotracheal tube (ETT). Ten milligrams of intravenous dexamethasone is administered after induction.
| Study group | Role | What they receive |
|---|---|---|
| Quadratus lumborum block | Active comparator | Patients in this arm will receive quadratus lumborum block with 20-30 ml of 0.25% Bupivacaine after induction of anesthesia and after operation. Receives: Procedure: Quadratus Lumborum Block (QLB); Procedure: General Anesthesia |
| Spinal anesthesia adjuvant | Experimental | Patients in this arm will receive 10 mg 0.5% hyperbaric Bupivacaine, 100 mcg Morphine, 100 mcg Sulfas Atropine, and 0.9% normal saline to total volume of 4 ml before induction of anesthesia. Receives: Procedure: Spinal anesthesia adjuvant; Procedure: General Anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain
Postoperative pain measured with Numerical Rating Scale (NRS) during rest and movement.
Measured: Hour 2, 6, 12, and 24
Opioid requirement
Morphine requirement on Patient-Controlled Analgesia (PCA).
Measured: Hour 2, 6, 12, and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2025
- Study start10 Feb 2025
- Primary completion30 Dec 2025
- Study completion31 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic Donor NephrectomyStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Collaborators
- Dr Cipto Mangunkusumo General Hospital
- Responsible party
- Principal investigator, Dita Aditianingsih, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06764667
- Sponsor's protocol ID
- IndonesiaUAnes048
- Status last verified
- Jun 2026
- First submitted
- 2 Jan 2025
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Spinal Anesthesia Adjuvant and Quadratus Lumborum Block on the Opioid Requirement and Perioperative Pain of Laparoscopic Kidney Transplant Donor
- ClinicalTrials.gov ID
- NCT06764667
- Acronym / sponsor ID
- IndonesiaUAnes048
- Keywords
- Quadratus lumborum block, Spinal anesthesia adjuvant, Laparoscopic donor nephrectomy, Perioperative pain management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Collaborators
- Dr Cipto Mangunkusumo General Hospital
- Study start
- 10 Feb 2025 (actual)
- Primary completion
- 30 Dec 2025 (actual)
- Study completion
- 31 Jan 2026 (actual)
- First posted
- 8 Jan 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.
This study aims to compare the effectiveness of spinal anesthesia adjuvant and quadratus lumborum block on the opioid requirement and perioperative pain on patients undergoing laparoscopic kidney transplant donor.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Quadratus lumborum block | Active comparator | Procedure: Quadratus Lumborum Block (QLB), Procedure: General AnesthesiaPatients in this arm will receive quadratus lumborum block with 20-30 ml of 0.25% Bupivacaine after induction of anesthesia and after operation. |
| Spinal anesthesia adjuvant | Experimental | Procedure: Spinal anesthesia adjuvant, Procedure: General AnesthesiaPatients in this arm will receive 10 mg 0.5% hyperbaric Bupivacaine, 100 mcg Morphine, 100 mcg Sulfas Atropine, and 0.9% normal saline to total volume of 4 ml before induction of anesthesia. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged 18-65 years undergoing laparoscopic donor nephrectomy
- Patients with BMI ≤ 35 kg/m2
- Patients with American Society of Anesthesiology (ASA) physical status 1-2
- Patients who are willing to participate in this study
Key exclusion criteria (7 listed)
- Cardiovascular disease (uncontrolled stage 2 hypertension, heart failure, arrhytmia)
- Recent onset cerebrovascular diseasae of < 3 months
- Infection on spinal site
- Coagulopathy
- Elevated intracranial pressure
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 |
|---|---|---|
| Spinal anesthesia adjuvantPatients in this arm will receive 10 mg 0.5% hyperbaric Bupivacaine, 100 mcg Morphine, 100 mcg Sulfas Atropine, and 0.9% normal saline to total volume of 4 ml before induction of anesthesia. | Procedure or surgery | Spinal anesthesia adjuvant |
| Quadratus Lumborum Block (QLB)Patients in this arm will receive quadratus lumborum block with 20-30 ml of 0.25% Bupivacaine after induction of anesthesia and after operation. | Procedure or surgery | Quadratus lumborum block |
| General AnesthesiaThe subject will undergo preoxygenation with 100% oxygen for 3 minutes. Following preoxygenation, anesthesia induction will be performed using lidocaine at a dose of 1.5 mg/kg, fentanyl at 1.5 mcg/kg, and propofol at 2.0 mg/kg. Once the subject is adequately sedated, baseline neuromuscular monitoring using the train-of-four (TOF) technique will be conducted, followed by the administration of rocuronium at a dose of 0.8 mg/kg. Endotracheal intubation will be performed using direct laryngoscopy once the TOF value reaches 0, utilizing an appropriately sized endotracheal tube (ETT). Ten milligrams of intravenous dexamethasone is administered after induction. | Procedure or surgery | Quadratus lumborum block, Spinal anesthesia adjuvant |
Primary outcome
Postoperative pain
Time frame: Hour 2, 6, 12, and 24
Postoperative pain measured with Numerical Rating Scale (NRS) during rest and movement.
Opioid requirement
Time frame: Hour 2, 6, 12, and 24
Morphine requirement on Patient-Controlled Analgesia (PCA).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
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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 Spinal anesthesia adjuvant, Quadratus Lumborum Block (QLB) and General Anesthesia in people with Laparoscopic Donor Nephrectomy and Perioperative Pain Management, 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 4 inclusion and 7 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: finished, as of the sponsor's last update on 8 Jun 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Postoperative pain (time frame: Hour 2, 6, 12, and 24). The study lists 2 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 8 Jun 2026.