Two Bupivacaine Concentrations for Erector Spinae Plane Block in Percutaneous Nephrolithotomy (ESPB-PNL)
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.
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Kontakty a umístění
Studijní místa
-
-
Mamak
-
Ankara, Mamak, Turecko (Türkiye), 06420
- Ankara Training and Research Hospital
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Metoda odběru vzorků
Studijní populace
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
|---|---|
|
group 1
0.25% Bupivacaine 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.
|
|
group 2
0.375% bupivacaine 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.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Postoperative pain intensity assessed using the Visual Analog Scale (VAS) and total opioid consumption
Časové okno: 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.
|
36 hours after surgery
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
inflammatory markers
Časové okno: 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.
|
24 hours after surgery
|
Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Studijní židle: suna akın takmaz, proffessor doctor, University of Health Sciences, Ankara Training and Research Hospital, Ankara, Türkiye
Publikace a užitečné odkazy
Obecné publikace
- 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.
- 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.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- E-24-130
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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