Clinical Trial: Optimizing Initial Bolus Volume During Serratus Anterior Plane Block Catheter Placement for Programmed Intermittent Bolus Analgesia in Minimally Invasive Cardiac Surgery: A Randomized Controlled Trial (Japan)

Tokyo, April 5 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061158) titled 'Optimizing Initial Bolus Volume During Serratus Anterior Plane Block Catheter Placement for Programmed Intermittent Bolus Analgesia in Minimally Invasive Cardiac Surgery: A Randomized Controlled Trial' on April 5.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -but assessor(s) are blinded Control - Active

Primary Sponsor: Institute - Department of Anesthesiology and Critical Care Medicine

Condition: Condition - Postoperative pain in minimally invasive cardiac surgery Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The purpose of this study is to evaluate the effect of the initial injection volume prior to catheter placement on catheter tip position in serratus anterior plane block, by comparing a low-volume group (3 mL) and a high-volume group (40 mL). Basic objectives2 - Others

Intervention: Interventions/Control_1 - At the end of surgery, an ultrasound-guided serratus anterior plane block was performed. A 17gauge Tuohy needle was used for needle insertion, and an initial bolus of 3 mL of 0.25% levobupivacaine was administered. After placement of the catheter (Arrow FlexTip Plus, Teleflex, PA, USA), an additional 37 mL of 0.25% levobupivacaine was injected. Following catheter placement, intermittent bolus administration of 6 mL of 0.25% levobupivacaine was performed every hour, with a total volume of 300 mL. During intubation, fentanyl was continuously infused at a rate of 0.3 mcg/kg/h. The fentanyl infusion was discontinued after extubation. Pain intensity was assessed using the NRS every 6 hours. Rescue analgesics were administered upon patient request. Interventions/Control_2 - At the end of surgery, an ultrasound-guided serratus anterior plane block was performed. A 17gauge Tuohy needle was used for needle insertion, and an initial bolus of 40 mL of 0.25% levobupivacaine was administered. A catheter (Arrow FlexTip Plus, Teleflex, PA, USA) was then inserted.Following catheter placement, intermittent bolus administration of 6 mL of 0.25% levobupivacaine was performed every hourwith a total volume of 300 mL. During intubation, fentanyl was continuously infused at a rate of 0.3 mcg/kg/h. The fentanyl infusion was discontinued after extubation. Pain intensity was assessed using the NRS every 6 hours. Rescue analgesics were administered upon patient request.

Eligibility: Age-lower limit - 18 years-old 30 kg/m2 Patients with a history of ipsilateral (right-sided) thoracic surgery Patients with psychiatric or neurological disorders In addition, patients who required conversion from minimally invasive cardiac surgery to open thoracotomy, or in whom catheter tip position could not be evaluated on chest radiography, were excluded from the final analysis. Target Size - 44

Recruitment Status: Recruitment status - Enrolling by invitation Date of protocol fixation - 2026 Year 04 Month 03 Day Date of IRB - 2026 Year 04 Month 03 Day Anticipated trial start date - 2026 Year 04 Month 05 Day Last follow-up date - 2028 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069987

Disclaimer: Curated by HT Syndication.