Percutaneous Nephrolithotomy (PNL)ESPB-PNLNCT07653230
Two Bupivacaine Concentrations for Erector Spinae Plane Block in Percutaneous Nephrolithotomy
An observational study of Percutaneous Nephrolithotomy (PNL) and Nephrolithiasis, run by Ankara Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
People who undergo percutaneous nephrolithotomy (PNL), a procedure used to remove kidney stones, often experience pain after surgery. An ultrasound-guided erector spinae plane block (ESPB) is commonly used to help reduce this pain. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Percutaneous Nephrolithotomy (PNL), Nephrolithiasis
- What is being tested?
- Erector spinae plane block (ESPB)
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2024to 19 Mar 2025
- How long will I take part?
- 2 Days
- Phase
- Observational
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consisted of adult patients undergoing elective percutaneous nephrolithotomy (PNL) for renal stone disease at a single tertiary care center between July 2024 and March 2025. Eligible participants were 18-70 years of age, classified as American Society of Anesthesiologists (ASA) physical status I-III, and received ultrasound-guided thoracic erector spinae plane block (ESPB) as part of perioperative analgesic management. A total of 60 participants were included and prospectively followed throughout the postoperative period.
Who may be able to join
- Age between 18 and 70 years.
- Scheduled to undergo elective percutaneous nephrolithotomy (PNL).
- American Society of Anesthesiologists (ASA) physical status I-III.
- Received ultrasound-guided thoracic erector spinae plane block (ESPB) before surgery.
- Willing and able to provide written informed consent.
Who cannot join
- Inability to assess pain using the Visual Analog Scale (VAS).
- Advanced cardiovascular disease.
- Coagulopathy or bleeding disorders.
- Opioid use disorder.
- Body mass index (BMI) ≥ 40 kg/m².
- Infection at the planned injection site.
- Known allergy or hypersensitivity to bupivacaine, other local anesthetics, or study-related medications.
- Withdrawal of consent during the study period.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Training and Research Hospital
Ankara, Mamak, 06420
About this study
Official title: Effects of Two Different Bupivacaine Concentrations in Ultrasound-Guided Thoracic Erector Spinae Plane Block on Postoperative Pain and Inflammatory Biomarkers After Percutaneous Nephrolithotomy
People who undergo percutaneous nephrolithotomy (PNL), a procedure used to remove kidney stones, often experience pain after surgery. An ultrasound-guided erector spinae plane block (ESPB) is commonly used to help reduce this pain.
This study compares two different concentrations of bupivacaine, a local anesthetic medication, used during ESPB. Participants undergoing PNL will receive either 0.25% or 0.375% bupivacaine as part of their pain management.
Researchers will compare pain scores, the need for additional pain medication, and changes in blood markers related to inflammation after surgery. The aim of the study is to determine whether one concentration provides better pain control or influences the inflammatory response differently after PNL.
Read the detailed description
Percutaneous nephrolithotomy (PNL) is the standard treatment for large and complex renal stones. Despite its minimally invasive nature, postoperative pain remains an important clinical concern and may adversely affect recovery, mobilization, and patient satisfaction. Ultrasound-guided thoracic erector spinae plane block (ESPB) has been increasingly incorporated into multimodal analgesia protocols because of its simplicity, safety profile, and effectiveness in reducing postoperative pain.
The optimal concentration of bupivacaine for ESPB in patients undergoing PNL remains unclear. This study was designed to compare the effects of two different concentrations of bupivacaine (0.25% and 0.375%) administered during ultrasound-guided thoracic ESPB on postoperative pain control and inflammatory response following PNL.
Adult patients scheduled for elective PNL were enrolled. ESPB was performed at the T10 vertebral level under ultrasound guidance before surgery. Participants received 20 mL of either 0.25% or 0.375% bupivacaine. Standard perioperative anesthetic and postoperative analgesic protocols were applied to all participants.
The primary outcome was postoperative pain intensity assessed using Visual Analog Scale (VAS) scores at predefined postoperative time points. Secondary outcomes included intraoperative fentanyl consumption, postoperative tramadol consumption, patient-controlled analgesia requirements, postoperative nausea and vomiting, patient satisfaction, and perioperative changes in inflammatory biomarkers, including the neutrophil-to-lymphocyte ratio (NLR) and platelet-to-lymphocyte ratio (PLR).
Demographic characteristics, stone-related variables, operative data, and perioperative hemodynamic parameters were recorded. Statistical analyses were performed to compare postoperative pain outcomes, analgesic requirements, and inflammatory biomarker responses between the study groups.
- Being tested
- Erector spinae plane block (ESPB)
- Keywords
- erector spina plane block, nephrolithiasis, percutaneous nephrolithotomy, bupivacaine, different concentrations
- Medical subject headings
- Nephrolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector spinae plane block (ESPB)Procedure or surgery
Ultrasound-guided thoracic erector spinae plane block was performed at the T10 vertebral level before surgery by an experienced anesthesiologist. A total volume of 20 mL bupivacaine was administered. Participants received either 0.25% or 0.375% bupivacaine according to the study cohort. The block was used as part of a multimodal analgesia protocol for postoperative pain management following percutaneous nephrolithotomy.
| Study group | Role | What they receive |
|---|---|---|
| group 1 | 0.25% Bupivacaine ESPB Receives: Procedure: Erector spinae plane block (ESPB) | |
| group 2 | 0.375% bupivacaine ESPB Receives: Procedure: Erector spinae plane block (ESPB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain intensity assessed using the Visual Analog Scale (VAS) and total opioid consumption
Postoperative pain intensity was assessed using the Visual Analog Scale (VAS; 0-10), where higher scores indicate greater pain severity. Pain scores and Total intraoperative and postoperative opioid consumption were recorded at 1, 3, 6, 12, 24, and 36 hours after surgery.
Measured: 36 hours after surgery
Secondary outcomes (1)
inflammatory markers
Changes in neutrophil-to-lymphocyte ratio and platelet-to-lymphocyte ratio measured before surgery and at 12 and 24 hours after surgery.
Measured: 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study start1 Jul 2024
- Primary completion18 Mar 2025
- Study completion19 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Percutaneous Nephrolithotomy (PNL)Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- Ankara Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Said Sencer Güney, Ankara Education and Research Hospital
- Investigators
- suna akın takmaz, proffessor doctor, Study chair, University of Health Sciences, Ankara Training and Research Hospital, Ankara, Türkiye
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07653230
- Sponsor's protocol ID
- E-24-130
- Acronym
- ESPB-PNL
- Status last verified
- Jun 2026
- First submitted
- 12 Jun 2026
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made publicly available because the informed consent obtained from participants did not include permission for public data sharing, and data confidentiality and privacy will be maintained in accordance with institutional and ethical requirements.
Publications
Altiparmak B, Korkmaz Toker M, Uysal AI, Gumus Demirbilek S. Comparison of the efficacy of erector spinae plane block performed with different concentrations of bupivacaine on postoperative analgesia after mastectomy surgery: ramdomized, prospective, double blinded trial. BMC Anesthesiol. 2019 Mar 4;19(1):31. doi: 10.1186/s12871-019-0700-3.
PubMed 30832580Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.
PubMed 27501016
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Two Different Bupivacaine Concentrations in Ultrasound-Guided Thoracic Erector Spinae Plane Block on Postoperative Pain and Inflammatory Biomarkers After Percutaneous Nephrolithotomy
- ClinicalTrials.gov ID
- NCT07653230
- Acronym / sponsor ID
- ESPB-PNL / E-24-130
- Keywords
- erector spina plane block, nephrolithiasis, percutaneous nephrolithotomy, bupivacaine, different concentrations
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ankara Education and Research HospitalOther government
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 18 Mar 2025 (actual)
- Study completion
- 19 Mar 2025 (actual)
- First posted
- 17 Jun 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.
People who undergo percutaneous nephrolithotomy (PNL), a procedure used to remove kidney stones, often experience pain after surgery. An ultrasound-guided erector spinae plane block (ESPB) is commonly used to help reduce this pain.
This study compares two different concentrations of bupivacaine, a local anesthetic medication, used during ESPB. Participants undergoing PNL will receive either 0.25% or 0.375% bupivacaine as part of their pain management.
Researchers will compare pain scores, the need for additional pain medication, and changes in blood markers related to inflammation after surgery. The aim of the study is to determine whether one concentration provides better pain control or influences the inflammatory response differently after PNL.
Detailed description
Percutaneous nephrolithotomy (PNL) is the standard treatment for large and complex renal stones. Despite its minimally invasive nature, postoperative pain remains an important clinical concern and may adversely affect recovery, mobilization, and patient satisfaction. Ultrasound-guided thoracic erector spinae plane block (ESPB) has been increasingly incorporated into multimodal analgesia protocols because of its simplicity, safety profile, and effectiveness in reducing postoperative pain.
The optimal concentration of bupivacaine for ESPB in patients undergoing PNL remains unclear. This study was designed to compare the effects of two different concentrations of bupivacaine (0.25% and 0.375%) administered during ultrasound-guided thoracic ESPB on postoperative pain control and inflammatory response following PNL.
Adult patients scheduled for elective PNL were enrolled. ESPB was performed at the T10 vertebral level under ultrasound guidance before surgery. Participants received 20 mL of either 0.25% or 0.375% bupivacaine. Standard perioperative anesthetic and postoperative analgesic protocols were applied to all participants.
The primary outcome was postoperative pain intensity assessed using Visual Analog Scale (VAS) scores at predefined postoperative time points. Secondary outcomes included intraoperative fentanyl consumption, postoperative tramadol consumption, patient-controlled analgesia requirements, postoperative nausea and vomiting, patient satisfaction, and perioperative changes in inflammatory biomarkers, including the neutrophil-to-lymphocyte ratio (NLR) and platelet-to-lymphocyte ratio (PLR).
Demographic characteristics, stone-related variables, operative data, and perioperative hemodynamic parameters were recorded. Statistical analyses were performed to compare postoperative pain outcomes, analgesic requirements, and inflammatory biomarker responses between the study groups.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1 | – | Procedure: Erector spinae plane block (ESPB)0.25% Bupivacaine ESPB |
| group 2 | – | Procedure: Erector spinae plane block (ESPB)0.375% bupivacaine ESPB |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consisted of adult patients undergoing elective percutaneous nephrolithotomy (PNL) for renal stone disease at a single tertiary care center between July 2024 and March 2025. Eligible participants were 18-70 years of age, classified as American Society of Anesthesiologists (ASA) physical status I-III, and received ultrasound-guided thoracic erector spinae plane block (ESPB) as part of perioperative analgesic management. A total of 60 participants were included and prospectively followed throughout the postoperative period.
Key inclusion criteria (5 listed)
- Age between 18 and 70 years.
- Scheduled to undergo elective percutaneous nephrolithotomy (PNL).
- American Society of Anesthesiologists (ASA) physical status I-III.
- Received ultrasound-guided thoracic erector spinae plane block (ESPB) before surgery.
- Willing and able to provide written informed consent.
Key exclusion criteria (8 listed)
- Inability to assess pain using the Visual Analog Scale (VAS).
- Advanced cardiovascular disease.
- Coagulopathy or bleeding disorders.
- Opioid use disorder.
- Body mass index (BMI) ≥ 40 kg/m².
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 plane block (ESPB)Ultrasound-guided thoracic erector spinae plane block was performed at the T10 vertebral level before surgery by an experienced anesthesiologist. A total volume of 20 mL bupivacaine was administered. Participants received either 0.25% or 0.375% bupivacaine according to the study cohort. The block was used as part of a multimodal analgesia protocol for postoperative pain management following percutaneous nephrolithotomy. | Procedure or surgery | group 1, group 2 |
Primary outcome
Postoperative pain intensity assessed using the Visual Analog Scale (VAS) and total opioid consumption
Time frame: 36 hours after surgery
Postoperative pain intensity was assessed using the Visual Analog Scale (VAS; 0-10), where higher scores indicate greater pain severity. Pain scores and Total intraoperative and postoperative opioid consumption were recorded at 1, 3, 6, 12, 24, and 36 hours after surgery.
1 secondary outcome
inflammatory markers
Time frame: 24 hours after surgery
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 17 Jun 2026.
- Results publication: PubMed 30832580Altiparmak B, Korkmaz Toker M, Uysal AI, Gumus Demirbilek S. Comparison of the efficacy of erector spinae plane block performed with different concentrations of bupivacaine on postoperative analgesia after mastectomy surgery: ramdomized, prospective, double blinded trial. BMC Anesthesiol. 2019 Mar 4;19(1):31. doi: 10.1186/s12871-019-0700-3.
- Results publication: PubMed 27501016Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.
- Individual participant dataSharing planned: No. Individual participant data will not be made publicly available because the informed consent obtained from participants did not include permission for public data sharing, and data confidentiality and privacy will be maintained in accordance with institutional and ethical requirements.
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Comparison of Myocardial Injury After Noncardiac Surgery (MINS) Incidence in Supine vs. Prone Positioning During Percutaneous Nephrolithotomy (PNL)
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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.
suna akın takmaz, proffessor doctor study chair
University of Health Sciences, Ankara Training and Research Hospital, Ankara, Türkiye
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Percutaneous Nephrolithotomy (PNL) and Nephrolithiasis, run by Ankara 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 5 inclusion and 8 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 17 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 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?
Postoperative pain intensity assessed using the Visual Analog Scale (VAS) and total opioid consumption (time frame: 36 hours after surgery). 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 NCT07653230, which also lists 2 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 17 Jun 2026.