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Two Bupivacaine Concentrations for Erector Spinae Plane Block in Percutaneous Nephrolithotomy

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07653230
Acronym
ESPB-PNL
Enrollment
60
Registered
2026-06-17
Start date
2024-07-01
Completion date
2025-03-19
Last updated
2026-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nephrolithiasis, Percutaneous Nephrolithotomy (PNL)

Keywords

erector spina plane block, nephrolithiasis, percutaneous nephrolithotomy, bupivacaine, different concentrations

Brief 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.

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.

Interventions

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.

Sponsors

Ankara Education and Research Hospital
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Postoperative pain intensity assessed using the Visual Analog Scale (VAS) and total opioid consumption36 hours after surgeryPostoperative 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

MeasureTime frameDescription
inflammatory markers24 hours after surgeryChanges in neutrophil-to-lymphocyte ratio and platelet-to-lymphocyte ratio measured before surgery and at 12 and 24 hours after surgery.

Countries

Turkey (Türkiye)

Contacts

STUDY_CHAIRsuna akın takmaz, proffessor doctor

University of Health Sciences, Ankara Training and Research Hospital, Ankara, Türkiye

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 18, 2026