Comparison Between Erector Spinae Plane Block and Spinal Block as Regional Anesthesia for Percutaneous Nephrolithotomy: Protocol for a Randomized Controlled Trial (Preprint)

BACKGROUND Erector spinae plane block (ESP) block is a novel interfacial block with a high margin of safety and highly effective for providing postoperative analgesia in Percutaneous Nephrolithotomy (PCNL). Combined with sedation, it may provide adequate surgical anesthesia with various advantages for PCNL procedure. OBJECTIVE The aim is to compare the effectiveness of ESP and subarachnoid block based on its conversion to a general anesthesia, interleukin-6 levels, postoperative pain, and opioid consumption in patients undergoing PCNL surgery. METHODS This is a randomized controlled trial on patients undergoing elective PCNL. All informed consent were obtained prior to the procedure. Patients were categorized into either ESP group or spinal group (1:1 ratio) with minimum sample size of 26 subjects in each arm using random allocation sampling. All patients were sedated using TCI propofol prior to receiving ultrasound-guided ESP block or spinal block. Sedation was maintained throughout the procedure. Sensory loss was evaluated by performing skin clamping at level of the incision before the surgery. RESULTS A total of 19 patients have been included in the study (7 ESP and 12 spinal subjects). A pilot study regarding its feasibility has been going as per February 2021. Primary results based on the pilot study are expected to be available by the early of 2022. CONCLUSIONS The randomized controlled trial is designed to provide high-quality evidence on comparison of effectiveness between erector spinae plane (ESP) block and spinal block as regional anaesthesia for percutaneous nephrolithotomy. CLINICALTRIAL ClinicalTrials.gov ID: NCT04947072