Kidney FailureNCT07369323
Erector Spinae Plane Block in Kidney Transplant Pain Management
A study testing ESP block in people with Kidney Failure, run by Dr. Lutfi Kirdar Kartal Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Use of postoperative analgesia in kidney transplant recipients has always been challenging due to several issues: potential nephrotoxicity of nonsteroidal anti- inflammatory drugs and the reduced clearance of morphine metabolites due to transient renal impairment.Moreover, many patients with end-stage renal disease on… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Kidney Failure
- What is being tested?
- ESP block
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2024to 1 May 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients had end-stage renal disease due to chronic glomerulonephritis _ physical status of class 3 on American Society of Anesthesiologists classification.
Who cannot join
- ASA 4
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Erector Spinae Plane Block for Postoperative Pain After Kidney Transplantation: A Prospective Study"
Use of postoperative analgesia in kidney transplant recipients has always been challenging due to several issues: potential nephrotoxicity of nonsteroidal anti- inflammatory drugs and the reduced clearance of morphine metabolites due to transient renal impairment.Moreover, many patients with end-stage renal disease on dialysis are hepatitis C or hepatitis B virus positive, and the use of other effective analgesics, such as acetaminophen, is limited.The use of regional analgesia methods for postoperative analgesia can also be a useful option for more adequate control in these patients. Currently, methods of fascial trunk nerve blocks (including rectus sheath block, different types of transversus abdominis plane block, and erector spinae plane [ESP] block) have been shown to be effective components of multimodal anesthesia in various fields of surgery.In this study, investigators evaluated the effectiveness of ESP block in the postoperative period after kidney transplant.The aim of this prospective, randomized controlled trial is to evaluate the effects of erector spinae plane block on postoperative analgesia quality, opioid consumption, and side effect profile in kidney transplant patients.The study included a total of 40 patients aged 18-65 years with ASA physical status II-III who were scheduled for elective kidney transplantation. All patients received standard general anesthesia. Anesthesia induction was achieved with propofol (2-2.5 mg/kg), fentanyl (1-2 µg/kg), and rocuronium (0.6 mg/kg). Anesthesia maintenance was provided with 6% desflurane and a 50% oxygen-air mixture.ESPB Group: USG-guided unilateral ESP block at T9 level (0.25% bupivacaine 20 ml)
- Control Group: no block applied
- All patients received standard postoperative analgesia protocol. Intravenous paracetamol (1 g/8 hours) was given. Intravenous tramadol (100 mg) was administered as rescue analgesic when VAS ≥ 4.
- Conditions
- Kidney Failure
- Being tested
- ESP block
- Keywords
- renal transplantation, erector spine plane block, pain management
- Medical subject headings
- Renal Insufficiency, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESP blockOther
USG-guided unilateral ESP block at T9 level (0.25% bupivacaine 20 ml)
| Study group | Role | What they receive |
|---|---|---|
| Control group | Other | tandard postoperative analgesia protocol was applied. Intravenous paracetamol (1 g/8 hours) was administered. ESP block not implemented Receives: Other: ESP block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperrative VAS scores at 24 hours
Postoperative Vas scores at 15 minutes, 1 hour, 2 hours, 6 hours, 12 hours, and 24 hours
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 posted27 Jan 2026
- Study start1 Feb 2024
- Primary completion1 Feb 2025
- Study completion1 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney FailureStudies 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
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Lutfi Kirdar Kartal Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Özlem Sezen, Dr. Lutfi Kirdar Kartal Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07369323
- Sponsor's protocol ID
- 514/250/6
- Status last verified
- May 2025
- First submitted
- 25 May 2025
- Last updated
- 27 Jan 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 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Erector Spinae Plane Block for Postoperative Pain After Kidney Transplantation: A Prospective Study"
- ClinicalTrials.gov ID
- NCT07369323
- Acronym / sponsor ID
- 514/250/6
- Conditions
- Kidney Failure
- Keywords
- renal transplantation, erector spine plane block, pain management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Dr. Lutfi Kirdar Kartal Training and Research HospitalOther government
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 Feb 2025 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 27 Jan 2026 (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.
Use of postoperative analgesia in kidney transplant recipients has always been challenging due to several issues: potential nephrotoxicity of nonsteroidal anti- inflammatory drugs and the reduced clearance of morphine metabolites due to transient renal impairment.Moreover, many patients with end-stage renal disease on dialysis are hepatitis C or hepatitis B virus positive, and the use of other effective analgesics, such as acetaminophen, is limited.The use of regional analgesia methods for postoperative analgesia can also be a useful option for more adequate control in these patients. Currently, methods of fascial trunk nerve blocks (including rectus sheath block, different types of transversus abdominis plane block, and erector spinae plane [ESP] block) have been shown to be effective components of multimodal anesthesia in various fields of surgery.In this study, investigators evaluated the effectiveness of ESP block in the postoperative period after kidney transplant.The aim of this prospective, randomized controlled trial is to evaluate the effects of erector spinae plane block on postoperative analgesia quality, opioid consumption, and side effect profile in kidney transplant patients.The study included a total of 40 patients aged 18-65 years with ASA physical status II-III who were scheduled for elective kidney transplantation. All patients received standard general anesthesia. Anesthesia induction was achieved with propofol (2-2.5 mg/kg), fentanyl (1-2 µg/kg), and rocuronium (0.6 mg/kg). Anesthesia maintenance was provided with 6% desflurane and a 50% oxygen-air mixture.ESPB Group: USG-guided unilateral ESP block at T9 level (0.25% bupivacaine 20 ml)
- Control Group: no block applied
- All patients received standard postoperative analgesia protocol. Intravenous paracetamol (1 g/8 hours) was given. Intravenous tramadol (100 mg) was administered as rescue analgesic when VAS ≥ 4.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Control group | Other | Other: ESP blocktandard postoperative analgesia protocol was applied. Intravenous paracetamol (1 g/8 hours) was administered. ESP block not implemented |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients had end-stage renal disease due to chronic glomerulonephritis _ physical status of class 3 on American Society of Anesthesiologists classification.
Key exclusion criteria (1 listed)
- ASA 4
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 |
|---|---|---|
| ESP blockUSG-guided unilateral ESP block at T9 level (0.25% bupivacaine 20 ml) | Other | Control group |
Primary outcome
Postoperrative VAS scores at 24 hours
Time frame: postoperative 24 hours
Postoperative Vas scores at 15 minutes, 1 hour, 2 hours, 6 hours, 12 hours, and 24 hours
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 27 Jan 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 ESP block in people with Kidney Failure, run by Dr. Lutfi Kirdar Kartal Training 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 1 inclusion and 1 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 27 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?
Postoperrative VAS scores at 24 hours (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 27 Jan 2026.