ClinicalTrials.gg
CompletedNCT07653230ESPB-PNLUpdated Jun 17, 2026

Two Bupivacaine Concentrations for Erector Spinae Plane Block in Percutaneous Nephrolithotomy

An observational study in Percutaneous Nephrolithotomy (PNL) and Nephrolithiasis, sponsored by Ankara Education and Research Hospital. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-06-17.

Sponsored by Ankara Education and Research Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
60
Ages
18 Years to 70 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 26 studies in Nephrolithiasis with a site in Turkey — 6 open to participants now, 7 under way, none of them phase 3. Nephrolithiasis · Turkey.

Enrollment
10th of 11
60 · median 105
Started
2024
with 4 others
Observational
11 of 26
2 open now
Registered
21st of 26
by date
Lead sponsor
1 of 26
Ankara Education and Research Hospital

Among the 26 studies in Nephrolithiasis with a site in Turkey, this one is the 10th largest by enrollment of the 11 observational ones, is one of 5 that started in 2024, is one of 11 observational ones, and was the 21st registered.

By phase

26 studies; the count open now beside each. This study's row is marked.

No phase12 · 4 open
Observationalthis study11 · 2 open
Phase 43 · 0 open

By the year they started

First in 2005; this study’s year is marked. 5 started in 2024.

Size and results

Median enrollment 84 across the 15 interventional studies, 105 across the 11 observational. Of the 16 that completed or were terminated, 0 (0%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 26 studies in Nephrolithiasis with a site in Turkey, or all of them as a file.
02

Study 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.

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.

03

Conditions studied

  • Percutaneous Nephrolithotomy (PNL)
  • Nephrolithiasis

Browse trials for

Keywords

  • erector spina plane block
  • nephrolithiasis
  • percutaneous nephrolithotomy
  • bupivacaine
  • different concentrations
04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age between 18 and 70 years.
  • Scheduled to undergo elective percutaneous nephrolithotomy (PNL).
  • (ASA) physical status I-III.
  • Received ultrasound-guided thoracic erector spinae plane block (ESPB) before surgery.
  • Willing and able to provide written .

Exclusion criteria

Exclusion Criteria:

  • Inability to assess pain using the Visual Analog Scale (VAS).
  • Advanced cardiovascular disease.
  • Coagulopathy or bleeding disorders.
  • Opioid use disorder.
  • (BMI) ≥ 40 kg/m².
  • Infection at the planned injection site.
  • Known allergy or to bupivacaine, other local anesthetics, or study-related medications.
  • Withdrawal of consent during the study period.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
60 participants (actual)
Target follow-up
2 Days
Patient registry
Yes

Groups and cohorts

  • group 1

    0.25% Bupivacaine ESPB

    Procedure: Erector spinae plane block (ESPB)

  • group 2

    0.375% bupivacaine ESPB

    Procedure: Erector spinae plane block (ESPB)

Interventions

  • ProcedureErector 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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.

    Time frame: 24 hours after surgery

07

Study locations

1 site
  • Ankara Training and Research Hospital
    Ankara, Mamak 06420, Turkey (Türkiye)
08

References and documents

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 30832580 ↗
  • Forero 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 ↗

Individual participant data

Plan to share: 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.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jul 2024 to primary completion in Mar 2025, 8 months.

Of 27 observational studies under Nephrolithiasis, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 54. This study's 8 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 12, 2026
First posted
Jun 17, 2026
StartActual
Jul 1, 2024
Primary completionActual
Mar 18, 2025
CompletionActual
Mar 19, 2025
Last update
Jun 17, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07653230
Lead sponsor
Ankara Education and Research Hospital
Responsible party
Said Sencer Güney (Anesthesiology Specialist, Ankara Education and Research Hospital) — Principal investigator
First posted
Jun 17, 2026
Start date
Jul 1, 2024
Primary completion
Mar 18, 2025
Completion
Mar 19, 2025
Last update
Jun 17, 2026

Study contacts

suna akın takmaz, proffessor doctor
study chair · University of Health Sciences, Ankara Training and Research Hospital, Ankara, Türkiye

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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