Kidney DiseasesNCT06298227
Erector Spinae Plane Block vs Quadratus Lumborum Block for Laparoscopic Nephrectomy
A study testing Postoperative analgesia management with Paracerol® and IV PCA with Talinat®, Erector spinae plane block and Quadratus lumborum plane block in people with Kidney Diseases and Kidney Failure, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
Ultrasound (US) guided Quadratus Lumborum Block (QLB) is performed at the level of the 12th rib, in the parasagittal oblique plane, at the L1-L2 level. As there are modifications of the block generally local anesthetic is given between quadratus lumborum (QL) and psoas major (PM) muscles (Anterior QLB). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Kidney Diseases, Kidney Failure
- What is being tested?
- Postoperative analgesia management with Paracerol® and IV PCA with Talinat®, Erector spinae plane block and Quadratus lumborum plane block
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Mar 2024to 30 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
- American Society of Anesthesiologists (ASA) classification I-II
- Scheduled for living donor laparoscopic nephrectomy under general anesthesia
Who cannot join
- history of bleeding diathesis,
- receiving anticoagulant treatment,
- known local anesthetics and opioid allergy,
- infection of the skin at the site of the needle puncture,
- pregnancy or lactation,
- patients who refuse the procedure or participation in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medipol University Mega Hospital Complex
Istanbul, Bağcılar
About this study
Official title: The Comparison of Erector Spinae Plane Block and Quadratus Lumborum Block on Postoperative Analgesia in Patients Undergoing Laparoscopic Nephrectomy: A Randomized, Prospective, Controlled Study
Ultrasound (US) guided Quadratus Lumborum Block (QLB) is performed at the level of the 12th rib, in the parasagittal oblique plane, at the L1-L2 level. As there are modifications of the block generally local anesthetic is given between quadratus lumborum (QL) and psoas major (PM) muscles (Anterior QLB). The QLB provides a sensory block between T7 - L1. Therefore, QLBs are used to provide postoperative analgesia for abdominal, obstetric, gynecologic, and urologic surgeries.
US-guided erector spinae plane block (ESPB) is performed at the level of the T11 transverse process. After visualization of the erector spinae (ES) muscle and the transverse process, local anesthetic is injected under the ES muscle. ESPB provides a sensory block of the anterior, posterior, and lateral thoracic and abdominal walls accordingly it's used for postoperative analgesia after thoracal wall repairs, thoracotomies, percutaneous nephrolithotomies, nephrectomies, and ventral hernia repairs.
This study aims to compare the effectiveness of US-guided ESPB and QLB on postoperative pain control after laparoscopic nephrectomy.
Read the detailed description
Nephrectomy for renal transplantation is a commonly performed procedure. The laparoscopic live donor nephrectomy (LLDN) is associated with many benefits and has become the gold standard for kidney retrieval surgery. As compared to open donor nephrectomy (ODN), LLDN has been shown to have less post-operative pain, shorter hospital stays, and faster recovery. Even though LLDN is less traumatic, some patients undergoing laparoscopic live donor nephrectomy still suffer significant postoperative pain require parenteral opioids, and have a risk for chronic pain.
The postoperative pain mechanism of LLDN is multifactorial - port pain, pain caused by incisions to retrieve the kidney, pelvic organ nociception, diaphragmatic irritation, and discomfort of a urinary catheter. Opioids, epidural anesthesia, Transversus Abdominal Plane (TAP) Block, and local infiltration of local anesthetics are used to prevent postoperative pain after LLDN.
In this study, the investigators aim to compare the effectiveness of US-guided ESPB and QLB on postoperative pain control after laparoscopic nephrectomy.
- Conditions
- Kidney Diseases, Kidney Failure
- Being tested
- Postoperative analgesia management with Paracerol® and IV PCA with Talinat®, Erector spinae plane block, Quadratus lumborum plane block
- Keywords
- Laparoscopic nephrectomy, Postoperative pain management, Erector spinae plane block, Quadratus lumborum block
- Medical subject headings
- Kidney Diseases, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postoperative analgesia management with Paracerol® and IV PCA with Talinat®Other
In the postoperative period, 1 g of acetaminophen (Paracerol®) will be administered intravenously to patients every 8 hours. Patients in all groups will have IV patient-controlled analgesia (PCA- CADD-Solis®) containing 10 mcg/ml fentanyl ( Talinat®). 10 mcg bolus without infusion dose, 20-minute lock time will be the protocol. Postoperative patient evaluation will be performed by another anesthesiologist. If the NRS score is ≥ 4, 0.5 mg/kg IV meperidine (Aldolan®) will be administered as a rescue analgesic.
Erector spinae plane blockOther
The block will be applied while the patient is in the lateral decubitus position. The convex probe of US ( GE Healthcare®) will be placed longitudinally 4 cm lateral to the T11 transverse process. The erector spinae muscle and the hyperechoic transverse process will be visualized. Using the in-plane technique, the 100 mm block needle (Stimuplex 360®) will be advanced in the cranio-caudal direction and 5 ml of saline will be injected under the erector spinae muscle to confirm the block location. Once the block location is confirmed, 40 ml of 0.25% bupivacaine (Marcaine®) will be administered.
Quadratus lumborum plane blockOther
QLB will be performed with the patient in the lateral decubitus position. The convex probe of US ( GE Healthcare®) will be placed at the level of the 12th rib, just above the iliac crest, in the parasagittal oblique plane, at the L1-L2 level. After the quadratus lumborum, erector spinae, and psoas major muscles are visualized, a 100 mm block needle (Stimuplex 360®) will be advanced in-plane anteriorly to QL, and the needle tip will be brought between the QL and PM muscles (Anterior QLB). The location will be confirmed by hydraulic dissection with 5 ml saline injection. After the block location is confirmed, 40 ml of 0.25% bupivacaine (Marcaine®) will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Group ESPB = Erector spinae plane block group | Active comparator | ESPB will be performed Receives: Other: Postoperative analgesia management with Paracerol® and IV PCA with Talinat®; Other: Erector spinae plane block |
| Group QLB = Quadratus lumborum block group | Active comparator | QLB will be performed Receives: Other: Postoperative analgesia management with Paracerol® and IV PCA with Talinat®; Other: Quadratus lumborum plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of total opioid consumption (Fentanyl PCA) at the first 24 hours period postoperatively
The primary aim is to compare postoperative opioid consumption from the PCA device.
Measured: Changes from baseline opioid consumption at postoperative 1, 2, 4, 8, 16 and 24 hours.
Secondary outcomes (3)
Pain scores (Numerical rating scale-NRS)
The secondary aim is to compare NRS at the postoperative 24 h. Postoperative pain assessment will be performed using the NRS (0 = no pain, 10 = the most severe pain felt). The NRS scores will be recorded
Measured: Changes from baseline pain scores at postoperative 1, 2, 4, 8, 16 and 24 hours
Need for rescue analgesia (meperidine)
The secondary aim is to compare rescue analgesia used in the postoperative 24 h.
Measured: Postoperative 24 hours period
Adverse events
The secondary aim is to compare the adverse events (nausea, vomiting, itching) related to opioid use.
Measured: Postoperative 24 hours period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2024
- Study start11 Mar 2024
- Primary completion30 Jan 2026
- Study completion30 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Kidney DiseasesStudies of the same condition, open and under way.
- 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
- Model description
- Sixty patients aged 18-65 years old with American Society of Anesthesiologists (ASA) classification I-II and scheduled for laparoscopic nephrectomy surgery will be included in the study. Patients will be randomly divided into two groups (Group ESPB = ESPB group, Group QLB = QLB group) including 30 patients each, before entering the operating room.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayse Ince, Istanbul Medipol University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06298227
- Sponsor's protocol ID
- Medipol Hospital 1
- Status last verified
- Apr 2026
- First submitted
- 6 Feb 2024
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The investigators will not share individual patient data(IPD)
Publications
Elsharkawy H, Ahuja S, Sessler DI, Maheshwari K, Mao G, Sakr Esa WA, Soliman LM, Ayad S, Khoshknabi D, Khan MZ, Raza S, DeGrande S, Turan A. Subcostal Anterior Quadratus Lumborum Block Versus Epidural Block for Analgesia in Open Nephrectomy: A Randomized Clinical Trial. Anesth Analg. 2021 Apr 1;132(4):1138-1145. doi: 10.1213/ANE.0000000000005382.
PubMed 33617181Alvi AS, Nasir JA, Nizam MA, Hamdani MM, Bhangar NA, Sibtain SA, Lalani AS, Warle MC. Quadratus lumborum block and transversus abdominis plane block in laparoscopic nephrectomy: a meta-analysis. Pain Manag. 2023 Sep;13(9):555-567. doi: 10.2217/pmt-2023-0033. Epub 2023 Sep 18.
PubMed 37718911Wang J, Chu T, Sun R, Xu A. Analgesic Efficacy of Quadratus Lumborum Block in Patients Undergoing Nephrectomy: A Systematic Review and Meta-Analysis. Pain Med. 2023 May 2;24(5):476-487. doi: 10.1093/pm/pnac166.
PubMed 36321993Sahin A, Baran O. Effect of ultrasound-guided erector spinae plane block on post-surgical pain in patients undergoing nephrectomy: a single-center, randomized, double-blind, controlled trial. J Int Med Res. 2022 Mar;50(3):3000605221086737. doi: 10.1177/03000605221086737.
PubMed 35301896Fan Q, Liu H, Li Y, Dai H, Wang Y. Comparison of ultrasound-guided erector spinae plane block and thoracic paravertebral block for postoperative analgesia after laparoscopic nephrectomy: a randomized controlled non-inferiority clinical trial. Minerva Anestesiol. 2023 Jun;89(6):520-528. doi: 10.23736/S0375-9393.22.16794-5. Epub 2023 Jan 24.
PubMed 36692339
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of Erector Spinae Plane Block and Quadratus Lumborum Block on Postoperative Analgesia in Patients Undergoing Laparoscopic Nephrectomy: A Randomized, Prospective, Controlled Study
- ClinicalTrials.gov ID
- NCT06298227
- Acronym / sponsor ID
- Medipol Hospital 1
- Conditions
- Kidney Diseases, Kidney Failure
- Keywords
- Laparoscopic nephrectomy, Postoperative pain management, Erector spinae plane block, Quadratus lumborum block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 11 Mar 2024 (actual)
- Primary completion
- 30 Jan 2026 (actual)
- Study completion
- 30 Jan 2026 (actual)
- First posted
- 7 Mar 2024 (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.
Ultrasound (US) guided Quadratus Lumborum Block (QLB) is performed at the level of the 12th rib, in the parasagittal oblique plane, at the L1-L2 level. As there are modifications of the block generally local anesthetic is given between quadratus lumborum (QL) and psoas major (PM) muscles (Anterior QLB). The QLB provides a sensory block between T7 - L1. Therefore, QLBs are used to provide postoperative analgesia for abdominal, obstetric, gynecologic, and urologic surgeries.
US-guided erector spinae plane block (ESPB) is performed at the level of the T11 transverse process. After visualization of the erector spinae (ES) muscle and the transverse process, local anesthetic is injected under the ES muscle. ESPB provides a sensory block of the anterior, posterior, and lateral thoracic and abdominal walls accordingly it's used for postoperative analgesia after thoracal wall repairs, thoracotomies, percutaneous nephrolithotomies, nephrectomies, and ventral hernia repairs.
This study aims to compare the effectiveness of US-guided ESPB and QLB on postoperative pain control after laparoscopic nephrectomy.
Detailed description
Nephrectomy for renal transplantation is a commonly performed procedure. The laparoscopic live donor nephrectomy (LLDN) is associated with many benefits and has become the gold standard for kidney retrieval surgery. As compared to open donor nephrectomy (ODN), LLDN has been shown to have less post-operative pain, shorter hospital stays, and faster recovery. Even though LLDN is less traumatic, some patients undergoing laparoscopic live donor nephrectomy still suffer significant postoperative pain require parenteral opioids, and have a risk for chronic pain.
The postoperative pain mechanism of LLDN is multifactorial - port pain, pain caused by incisions to retrieve the kidney, pelvic organ nociception, diaphragmatic irritation, and discomfort of a urinary catheter. Opioids, epidural anesthesia, Transversus Abdominal Plane (TAP) Block, and local infiltration of local anesthetics are used to prevent postoperative pain after LLDN.
In this study, the investigators aim to compare the effectiveness of US-guided ESPB and QLB on postoperative pain control after laparoscopic nephrectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Sixty patients aged 18-65 years old with American Society of Anesthesiologists (ASA) classification I-II and scheduled for laparoscopic nephrectomy surgery will be included in the study. Patients will be randomly divided into two groups (Group ESPB = ESPB group, Group QLB = QLB group) including 30 patients each, before entering the operating room.
| Arm | Type | Receives |
|---|---|---|
| Group ESPB = Erector spinae plane block group | Active comparator | Other: Postoperative analgesia management with Paracerol® and IV PCA with Talinat®, Other: Erector spinae plane blockESPB will be performed |
| Group QLB = Quadratus lumborum block group | Active comparator | Other: Postoperative analgesia management with Paracerol® and IV PCA with Talinat®, Other: Quadratus lumborum plane blockQLB will be performed |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists (ASA) classification I-II
- Scheduled for living donor laparoscopic nephrectomy under general anesthesia
Key exclusion criteria (6 listed)
- history of bleeding diathesis,
- receiving anticoagulant treatment,
- known local anesthetics and opioid allergy,
- infection of the skin at the site of the needle puncture,
- pregnancy or lactation,
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 |
|---|---|---|
| Postoperative analgesia management with Paracerol® and IV PCA with Talinat®In the postoperative period, 1 g of acetaminophen (Paracerol®) will be administered intravenously to patients every 8 hours. Patients in all groups will have IV patient-controlled analgesia (PCA- CADD-Solis®) containing 10 mcg/ml fentanyl ( Talinat®). 10 mcg bolus without infusion dose, 20-minute lock time will be the protocol. Postoperative patient evaluation will be performed by another anesthesiologist. If the NRS score is ≥ 4, 0.5 mg/kg IV meperidine (Aldolan®) will be administered as a rescue analgesic. | Other | Group ESPB = Erector spinae plane block group, Group QLB = Quadratus lumborum block group |
| Erector spinae plane blockThe block will be applied while the patient is in the lateral decubitus position. The convex probe of US ( GE Healthcare®) will be placed longitudinally 4 cm lateral to the T11 transverse process. The erector spinae muscle and the hyperechoic transverse process will be visualized. Using the in-plane technique, the 100 mm block needle (Stimuplex 360®) will be advanced in the cranio-caudal direction and 5 ml of saline will be injected under the erector spinae muscle to confirm the block location. Once the block location is confirmed, 40 ml of 0.25% bupivacaine (Marcaine®) will be administered. | Other | Group ESPB = Erector spinae plane block group |
| Quadratus lumborum plane blockQLB will be performed with the patient in the lateral decubitus position. The convex probe of US ( GE Healthcare®) will be placed at the level of the 12th rib, just above the iliac crest, in the parasagittal oblique plane, at the L1-L2 level. After the quadratus lumborum, erector spinae, and psoas major muscles are visualized, a 100 mm block needle (Stimuplex 360®) will be advanced in-plane anteriorly to QL, and the needle tip will be brought between the QL and PM muscles (Anterior QLB). The location will be confirmed by hydraulic dissection with 5 ml saline injection. After the block location is confirmed, 40 ml of 0.25% bupivacaine (Marcaine®) will be administered. | Other | Group QLB = Quadratus lumborum block group |
Primary outcome
Amount of total opioid consumption (Fentanyl PCA) at the first 24 hours period postoperatively
Time frame: Changes from baseline opioid consumption at postoperative 1, 2, 4, 8, 16 and 24 hours.
The primary aim is to compare postoperative opioid consumption from the PCA device.
3 secondary outcomes
Pain scores (Numerical rating scale-NRS)
Time frame: Changes from baseline pain scores at postoperative 1, 2, 4, 8, 16 and 24 hours
Need for rescue analgesia (meperidine)
Time frame: Postoperative 24 hours period
Adverse events
Time frame: Postoperative 24 hours period
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 29 Apr 2026.
- Background: PubMed 33617181Elsharkawy H, Ahuja S, Sessler DI, Maheshwari K, Mao G, Sakr Esa WA, Soliman LM, Ayad S, Khoshknabi D, Khan MZ, Raza S, DeGrande S, Turan A. Subcostal Anterior Quadratus Lumborum Block Versus Epidural Block for Analgesia in Open Nephrectomy: A Randomized Clinical Trial. Anesth Analg. 2021 Apr 1;132(4):1138-1145. doi: 10.1213/ANE.0000000000005382.
- Background: PubMed 37718911Alvi AS, Nasir JA, Nizam MA, Hamdani MM, Bhangar NA, Sibtain SA, Lalani AS, Warle MC. Quadratus lumborum block and transversus abdominis plane block in laparoscopic nephrectomy: a meta-analysis. Pain Manag. 2023 Sep;13(9):555-567. doi: 10.2217/pmt-2023-0033. Epub 2023 Sep 18.
- Background: PubMed 36321993Wang J, Chu T, Sun R, Xu A. Analgesic Efficacy of Quadratus Lumborum Block in Patients Undergoing Nephrectomy: A Systematic Review and Meta-Analysis. Pain Med. 2023 May 2;24(5):476-487. doi: 10.1093/pm/pnac166.
- Background: PubMed 35301896Sahin A, Baran O. Effect of ultrasound-guided erector spinae plane block on post-surgical pain in patients undergoing nephrectomy: a single-center, randomized, double-blind, controlled trial. J Int Med Res. 2022 Mar;50(3):3000605221086737. doi: 10.1177/03000605221086737.
- Background: PubMed 36692339Fan Q, Liu H, Li Y, Dai H, Wang Y. Comparison of ultrasound-guided erector spinae plane block and thoracic paravertebral block for postoperative analgesia after laparoscopic nephrectomy: a randomized controlled non-inferiority clinical trial. Minerva Anestesiol. 2023 Jun;89(6):520-528. doi: 10.23736/S0375-9393.22.16794-5. Epub 2023 Jan 24.
- Individual participant dataSharing planned: No. The investigators will not share individual patient data(IPD)
Related trials for Kidney Diseases
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Population Pharmacokinetics of Temocillin in Acute Enterobacterial Pyelonephritis in Children
Pyelonephritis
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
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 Postoperative analgesia management with Paracerol® and IV PCA with Talinat®, Erector spinae plane block and Quadratus lumborum plane block in people with Kidney Diseases and Kidney Failure, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
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 2 inclusion and 6 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 29 Apr 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 Turkey (Türkiye). 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?
Amount of total opioid consumption (Fentanyl PCA) at the first 24 hours period postoperatively (time frame: Changes from baseline opioid consumption at postoperative 1, 2, 4, 8, 16 and 24 hours.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06298227, which also lists 5 linked publications.
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 29 Apr 2026.