Clinical Trial: Ultrasound-Guided Bilateral re-M-TAPA Block Versus Surgical Wound Infiltration for Postoperative Analgesia After Robot-Assisted Radical Prostatectomy: A Prospective Randomized Assessor-Blinded Parallel-Group Trial (Japan)

Tokyo, April 22 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061323) titled 'Comparison of Ultrasound-Guided Bilateral re-M-TAPA Block and Surgical Wound Infiltration for Postoperative Analgesia After Robot-Assisted Radical Prostatectomy' on April 20.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Single blind -investigator(s) and assessor(s) are blinded Control - Active

Primary Sponsor: Institute - Kawasaki Medical School General Medical Center

Condition: Condition - Prostate Cancer, Postoperative Pain Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - The aim of this study is to evaluate the effect of ultrasound-guided bilateral re-M-TAPA block on postoperative analgesia compared with surgical wound infiltration in patients undergoing robot-assisted radical prostatectomy. The primary outcome is cumulative opioid consumption within 24 hours postoperatively, expressed as intravenous morphine milligram equivalents (MME). Secondary outcomes include postoperative pain scores (Numerical Rating Scale) at 2, 6, 12, and 24 hours, incidence of postoperative nausea and vomiting, time to first rescue analgesia, quality of recovery (QoR-15) at 24 hours, and sensory block distribution. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - In the intervention group, ultrasound-guided bilateral re-M-TAPA block will be performed after induction of general anesthesia and before the start of surgery. The type, concentration, and volume of local anesthetic will be determined according to the institutional protocol. Perioperative general anesthesia management and postoperative analgesic protocols will be standardized between the two groups. Interventions/Control_2 - In the control group, surgical wound infiltration with local anesthetic will be performed at the end of surgery. The type, concentration, and volume of local anesthetic will be determined according to the institutional protocol. Perioperative general anesthesia management and postoperative analgesic protocols will be standardized between the two groups.

Eligibility: Age-lower limit - 20 years-old <= Age-upper limit - Not applicable Gender - Male Key inclusion criteria - Male patients aged 20 years or older Scheduled for elective robot-assisted radical prostatectomy American Society of Anesthesiologists (ASA) physical status 1-3 Provided written informed consent Key exclusion criteria - History of allergy to local anesthetics Chronic opioid use prior to surgery Coagulopathy or ongoing anticoagulant therapy Infection at the injection site Severe obesity or anatomical difficulty precluding block performance Cognitive impairment interfering with pain assessment Target Size - 60

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 04 Month 25 Day Anticipated trial start date - 2026 Year 07 Month 01 Day Last follow-up date - 2027 Year 07 Month 01 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070161

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