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NCT Number: NCT07653230

Two Bupivacaine Concentrations for Erector Spinae Plane Block in 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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ankara Training and Research Hospital

Ankara, Mamak, 06420, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Erector spinae plane block (ESPB)

Procedure

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. inflammatory markers

    Time frame: 24 hours after surgery

    Changes in neutrophil-to-lymphocyte ratio and platelet-to-lymphocyte ratio measured before surgery and at 12 and 24 hours after surgery.

Sponsors and collaborators

Lead sponsor

Ankara Education and Research Hospital

Other Gov

Registry information

Official study title

Effects of Two Different Bupivacaine Concentrations in Ultrasound-Guided Thoracic Erector Spinae Plane Block on Postoperative Pain and Inflammatory Biomarkers After Percutaneous Nephrolithotomy

Acronym: ESPB-PNL

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 17, 2026
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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