Kidney TransplantNCT07059455
Erector Spınae Plane Block and Transmuscular Quadratus Lumborum Block In Kıdney Transplantatıon
A study testing Erector Spinae (ESP) Block with Bupivacaine (Marcaine®) and Quadratus Lumborum (QL) Block in people with Kidney Transplant, run by Kocaeli Derince Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Perioperative anesthesia and pain management are among the difficult situations for anesthesiologists to manage in kidney transplant patients. These patients are often complicated by comorbidities related to chronic kidney disease. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Kidney Transplant
- What is being tested?
- Erector Spinae (ESP) Block with Bupivacaine (Marcaine®) and Quadratus Lumborum (QL) Block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Mar 2025to 30 Sep 2025
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Renal transplantation
- Patients between the ages of 18-65
Who cannot join
- Patients who do not agree to participate in the study,
- Patients havecoagulopathy, liver function problems, local anesthetic allergy
- Body mass index (BMI) > 40
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kartal Dr Lutfi Kirdar City Hospital
Istanbul, Kartal, 34000
About this study
Official title: Comparıson Of Analgesıc Effectıveness Of Erector Spınae Plane Block and Transmuscular Quadratus Lumborum Block In Kıdney Transplantatıon
Perioperative anesthesia and pain management are among the difficult situations for anesthesiologists to manage in kidney transplant patients. These patients are often complicated by comorbidities related to chronic kidney disease. The main issues in postoperative pain management for kidney transplant patients include dose adjustment, prevention of further renal damage, and maintenance of graft perfusion. Pain management in patients with end-stage renal disease may be inadequate due to limited options of systemic analgesics. In addition, regional analgesia techniques can be considered to avoid the adverse effects of anesthetics and systemic analgesics (1).
Erector spinae plane block (ESPB) is a regional fascial plane block method developed in recent years. In this method, analgesia is provided by injecting local anesthetic between the transverse process and the erector spinae muscles and anesthetizing the dorsal and ventral branches of the regional spinal nerves. It has a wide range of applications including thoracic, lumbar, and thoracic and abdominal surgeries (2,3).
Read more
Transmuscular quadratus lumborum block (TMQLB) is a nerve block technique in which local anesthetic is applied to the fascial plane between the psoas major (PM) and quadratus lumborum (QL) muscles. Anatomical evidence has shown that local anesthetic can spread through the thoracolumbar fascia into the thoracic paravertebral space, thus infiltrating the thoracic spinal nerves and sympathetic trunk, providing both somatic and visceral analgesia for abdominal surgery (4).
This study aims to evaluate the analgesic efficacy of ESPB and TMQLB in terms of pain management after kidney transplantation. The primary aim of the study was to evaluate pain scores and analgesic consumption between groups in the 24-hour postoperative period. The secondary aim was to evaluate the time to first analgesic requirement after block, the number of patients requiring analgesics, and the levels of nausea and vomiting.
Read the detailed description
MATERIAL AND METHODS A total of 50 patients are planned to be included in this single-blind, prospective randomized controlled study planned to be conducted between June 10, 2025 and October 10, 2025 in the general surgery operating room of Kartal Dr. Lütfi Kırdar City Hospital.
All patients taken to the operating room will be subjected to standard monitoring techniques including temperature monitoring, electrocardiography (ECG), peripheral oxygen saturation (SpO2), end tidal carbon dioxide monitoring (EtCO2) and non-invasive blood pressure measurement, and then one of two regional anesthesia methods will be applied to the patients. Then, the surgical procedure will be started after standard general anesthesia induction and endotracheal intubation will be applied to the patients. 100 mg tramadol and 1 gr paracetamol will be administered to all patients iv for analgesia 15 minutes before the end of the operation, and 10 mg metoclopramide will be administered to patients iv for nausea and vomiting.
Randomization Patients will be divided into two groups as Group TMQLB; n=25 and Group ESPB; n=25 in a system where random numbers generated by the computer (SPSS v23.0, IBM, NewYork, USA) are used, with a ratio of 1:1. The physician who will follow up the patients postoperatively will be blind to the groups.
Power analysis As a result of the power analysis conducted for our study; the standard effect size was determined as 0.72 with a 5% margin of error and 80% power. It was decided to include a total of 50 cases, n=25 cases in each group.
Block application After regional sterile conditions are provided with 10% povidone iodine solution while the patient is in the supine position, 6-13 Mhz linear ultrasonography (USG Esaote, Via E. Melen, 77 16152 Genova, Italy) will be used for imaging for ESPB, 22 G and 100 mm block needle (Stimuplex® Ultra 360® B-Braun medical, Melsungen, Germany) will be inserted between the transverse process and the erector spinae muscle at the level of the T10 vertebra and 30 ml of a local anesthetic solution consisting of 0.25% bupivacaine will be administered to the side to be treated.
For imaging for TMQLB, 2-5 Mhz convex ultrasonography (USG Esaote, Via E. Melen, 77 16152 Genova, Italy) will be used, the transverse process will be visualized at the level of the L3 vertebra with a 22 G and 100 mm block needle (Stimuplex® Ultra 360® B-Braun medical, Melsungen, Germany), and 30 ml of a local anesthetic solution consisting of 0.25% bupivacaine will be administered to the side to be treated.
Standard postoperative analgesia protocol
1 g paracetamol will be administered intravenously to all patients every 8 hours during the postoperative 24-hour period. If the visual analog scale (VAS) values of the patients were 4 and above during follow-up, tramadol 100 mg was administered as an intravenous rescue analgesic.
Postoperative pain assessment Patients' pain levels will be assessed using a 10-point VAS at 0, 1, 2, 6, 12, and 24 hours. No pain will be assessed as 0 points, and severe pain will be assessed as 10 points. VAS scores, time to first analgesic requirement, and total tramadol consumption will be recorded.
- Conditions
- Kidney Transplant
- Being tested
- Erector Spinae (ESP) Block with Bupivacaine (Marcaine®), Quadratus Lumborum (QL) Block
- Keywords
- erectör spiane block, Quadratus lumborum block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector Spinae (ESP) Block with Bupivacaine (Marcaine®)Other
Under general anesthesia, patients in the ESP group will be positioned in the left or right lateral decubitus position, depending on the side of the surgical procedure. After the T10 spinous process is identified by manual examination, sterile conditions will be established. The transverse process and erector spinae muscles will be visualized using an ultrasound probe. Using an in-plane technique, 20 ml of 0.25% bupivacaine will be injected between the transverse process and erector spinae muscles using a 22-gauge blocking needle.
Quadratus Lumborum (QL) BlockOther
Following standard anesthesia monitoring, patients will be placed in the lateral decubitus position. After the field is sterilized, a 2-5 MHz convex ultrasound probe (Samsung, HM70 EVO) will be placed between the iliac crest and costal arch at the level of the posterior axillary line. The transverse process of the L4 vertebra, erector spinae, QL, and PM muscles will be visualized. After inducing local anesthesia with 2% lidocaine (2 ml), a blocking needle (22G*100 mm, Braun) will be advanced from posterolateral to anteromedial, inserting it between the QL and PM muscles, and 20 ml of 0.25% bupivacaine will be injected.
| Study group | Role | What they receive |
|---|---|---|
| erectör spinae plane block | Active comparator | Erector spinae plane block (ESPB) is a regional fascial plane block method developed in recent years. In this method, analgesia is provided by injecting local anesthetic between the transverse process and the erector spinae muscles and anesthetizing the dorsal and ventral branches of the regional spinal nerves. It has a wide range of use in thoracic, lumbar, and thoracic and abdominal surgeries Receives: Other: Erector Spinae (ESP) Block with Bupivacaine (Marcaine®) |
| Transmuskuler quadratus lumborum block | Active comparator | Transmuscular quadratus lumborum block (TMQLB) is a nerve block technique in which local anesthetic is applied to the fascial plane between the psoas major (PM) and quadratus lumborum (QL) muscles. Anatomical evidence has shown that local anesthetic can spread through the thoracolumbar fascia into the thoracic paravertebral space, thus infiltrating the thoracic spinal nerves and sympathetic trunk, providing both somatic and visceral analgesia for abdominal surgery Receives: Other: Quadratus Lumborum (QL) Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluate pain scores and analgesic consumption between groups
Patients' pain levels will be measured at 0, 1, 2, 6, 12, and 24 hours using a 10-point VAS. No pain will be assessed as 0 points, and severe pain will be assessed as 10 points.
Measured: postoperative 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2025
- Study start25 Mar 2025
- Primary completion30 Aug 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli Derince Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tahsin Şimşek, Kocaeli Derince Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07059455
- Sponsor's protocol ID
- 2015/514/154/11
- Status last verified
- Jun 2025
- First submitted
- 23 Jun 2025
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparıson Of Analgesıc Effectıveness Of Erector Spınae Plane Block and Transmuscular Quadratus Lumborum Block In Kıdney Transplantatıon
- ClinicalTrials.gov ID
- NCT07059455
- Acronym / sponsor ID
- 2015/514/154/11
- Conditions
- Kidney Transplant
- Keywords
- erectör spiane block, Quadratus lumborum block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Kocaeli Derince Education and Research HospitalUniversity, hospital or other
- Study start
- 25 Mar 2025 (actual)
- Primary completion
- 30 Aug 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 10 Jul 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.
Perioperative anesthesia and pain management are among the difficult situations for anesthesiologists to manage in kidney transplant patients. These patients are often complicated by comorbidities related to chronic kidney disease. The main issues in postoperative pain management for kidney transplant patients include dose adjustment, prevention of further renal damage, and maintenance of graft perfusion. Pain management in patients with end-stage renal disease may be inadequate due to limited options of systemic analgesics. In addition, regional analgesia techniques can be considered to avoid the adverse effects of anesthetics and systemic analgesics (1).
Erector spinae plane block (ESPB) is a regional fascial plane block method developed in recent years. In this method, analgesia is provided by injecting local anesthetic between the transverse process and the erector spinae muscles and anesthetizing the dorsal and ventral branches of the regional spinal nerves. It has a wide range of applications including thoracic, lumbar, and thoracic and abdominal surgeries (2,3).
Transmuscular quadratus lumborum block (TMQLB) is a nerve block technique in which local anesthetic is applied to the fascial plane between the psoas major (PM) and quadratus lumborum (QL) muscles. Anatomical evidence has shown that local anesthetic can spread through the thoracolumbar fascia into the thoracic paravertebral space, thus infiltrating the thoracic spinal nerves and sympathetic trunk, providing both somatic and visceral analgesia for abdominal surgery (4).
This study aims to evaluate the analgesic efficacy of ESPB and TMQLB in terms of pain management after kidney transplantation. The primary aim of the study was to evaluate pain scores and analgesic consumption between groups in the 24-hour postoperative period. The secondary aim was to evaluate the time to first analgesic requirement after block, the number of patients requiring analgesics, and the levels of nausea and vomiting.
Detailed description
MATERIAL AND METHODS A total of 50 patients are planned to be included in this single-blind, prospective randomized controlled study planned to be conducted between June 10, 2025 and October 10, 2025 in the general surgery operating room of Kartal Dr. Lütfi Kırdar City Hospital.
All patients taken to the operating room will be subjected to standard monitoring techniques including temperature monitoring, electrocardiography (ECG), peripheral oxygen saturation (SpO2), end tidal carbon dioxide monitoring (EtCO2) and non-invasive blood pressure measurement, and then one of two regional anesthesia methods will be applied to the patients. Then, the surgical procedure will be started after standard general anesthesia induction and endotracheal intubation will be applied to the patients. 100 mg tramadol and 1 gr paracetamol will be administered to all patients iv for analgesia 15 minutes before the end of the operation, and 10 mg metoclopramide will be administered to patients iv for nausea and vomiting.
Randomization Patients will be divided into two groups as Group TMQLB; n=25 and Group ESPB; n=25 in a system where random numbers generated by the computer (SPSS v23.0, IBM, NewYork, USA) are used, with a ratio of 1:1. The physician who will follow up the patients postoperatively will be blind to the groups.
Power analysis As a result of the power analysis conducted for our study; the standard effect size was determined as 0.72 with a 5% margin of error and 80% power. It was decided to include a total of 50 cases, n=25 cases in each group.
Block application After regional sterile conditions are provided with 10% povidone iodine solution while the patient is in the supine position, 6-13 Mhz linear ultrasonography (USG Esaote, Via E. Melen, 77 16152 Genova, Italy) will be used for imaging for ESPB, 22 G and 100 mm block needle (Stimuplex® Ultra 360® B-Braun medical, Melsungen, Germany) will be inserted between the transverse process and the erector spinae muscle at the level of the T10 vertebra and 30 ml of a local anesthetic solution consisting of 0.25% bupivacaine will be administered to the side to be treated.
For imaging for TMQLB, 2-5 Mhz convex ultrasonography (USG Esaote, Via E. Melen, 77 16152 Genova, Italy) will be used, the transverse process will be visualized at the level of the L3 vertebra with a 22 G and 100 mm block needle (Stimuplex® Ultra 360® B-Braun medical, Melsungen, Germany), and 30 ml of a local anesthetic solution consisting of 0.25% bupivacaine will be administered to the side to be treated.
Standard postoperative analgesia protocol
1 g paracetamol will be administered intravenously to all patients every 8 hours during the postoperative 24-hour period. If the visual analog scale (VAS) values of the patients were 4 and above during follow-up, tramadol 100 mg was administered as an intravenous rescue analgesic.
Postoperative pain assessment Patients' pain levels will be assessed using a 10-point VAS at 0, 1, 2, 6, 12, and 24 hours. No pain will be assessed as 0 points, and severe pain will be assessed as 10 points. VAS scores, time to first analgesic requirement, and total tramadol consumption will be recorded.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| erectör spinae plane block | Active comparator | Other: Erector Spinae (ESP) Block with Bupivacaine (Marcaine®)Erector spinae plane block (ESPB) is a regional fascial plane block method developed in recent years. In this method, analgesia is provided by injecting local anesthetic between the transverse process and the erector spinae muscles and anesthetizing the dorsal and ventral branches of the regional spinal nerves. It has a wide range of use in thoracic, lumbar, and thoracic and abdominal surgeries |
| Transmuskuler quadratus lumborum block | Active comparator | Other: Quadratus Lumborum (QL) BlockTransmuscular quadratus lumborum block (TMQLB) is a nerve block technique in which local anesthetic is applied to the fascial plane between the psoas major (PM) and quadratus lumborum (QL) muscles. Anatomical evidence has shown that local anesthetic can spread through the thoracolumbar fascia into the thoracic paravertebral space, thus infiltrating the thoracic spinal nerves and sympathetic trunk, providing both somatic and visceral analgesia for abdominal surgery |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Renal transplantation
- Patients between the ages of 18-65
Key exclusion criteria (3 listed)
- Patients who do not agree to participate in the study,
- Patients havecoagulopathy, liver function problems, local anesthetic allergy
- Body mass index (BMI) > 40
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 |
|---|---|---|
| Erector Spinae (ESP) Block with Bupivacaine (Marcaine®)Under general anesthesia, patients in the ESP group will be positioned in the left or right lateral decubitus position, depending on the side of the surgical procedure. After the T10 spinous process is identified by manual examination, sterile conditions will be established. The transverse process and erector spinae muscles will be visualized using an ultrasound probe. Using an in-plane technique, 20 ml of 0.25% bupivacaine will be injected between the transverse process and erector spinae muscles using a 22-gauge blocking needle. | Other | erectör spinae plane block |
| Quadratus Lumborum (QL) BlockFollowing standard anesthesia monitoring, patients will be placed in the lateral decubitus position. After the field is sterilized, a 2-5 MHz convex ultrasound probe (Samsung, HM70 EVO) will be placed between the iliac crest and costal arch at the level of the posterior axillary line. The transverse process of the L4 vertebra, erector spinae, QL, and PM muscles will be visualized. After inducing local anesthesia with 2% lidocaine (2 ml), a blocking needle (22G*100 mm, Braun) will be advanced from posterolateral to anteromedial, inserting it between the QL and PM muscles, and 20 ml of 0.25% bupivacaine will be injected. | Other | Transmuskuler quadratus lumborum block |
Primary outcome
evaluate pain scores and analgesic consumption between groups
Time frame: postoperative 24 hours
Patients' pain levels will be measured at 0, 1, 2, 6, 12, and 24 hours using a 10-point VAS. No pain will be assessed as 0 points, and severe pain will be assessed as 10 points.
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 16 Jan 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Kidney Transplant
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
RecruitingPhase 2
A Study of Mezagitamab in Adults With Late Antibody-Mediated Rejection (AMR) After a Kidney Transplant
Antibody-Mediated Rejection (AMR)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruitingEarly Phase 1
Biomarker-Guided Mycophenolate Mofetil Elimination in Low-Risk Older Adult Kidney Transplant Recipients
Kidney Transplant Recipient
Recruiting
Non-Invasive Monitoring of Pediatric Kidney Transplant Recipients and Immunosuppression Personalization: an Open-labeled Multicenter Randomized Controlled Study
Pediatric Kidney Disease, Transplant;Failure,Kidney
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 Erector Spinae (ESP) Block with Bupivacaine (Marcaine®) and Quadratus Lumborum (QL) Block in people with Kidney Transplant, run by Kocaeli Derince Education and Research 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 3 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 16 Jan 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?
evaluate pain scores and analgesic consumption between groups (time frame: postoperative 24 hours). 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 16 Jan 2026.