Tokyo, April 22 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061338) titled 'A study to compare different methods of local anesthesia during uterine surgery and their effects on pain' on April 21.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Double blind -all involved are blinded Control - Placebo

Primary Sponsor: Institute - Kobe City Nishi-Kobe Medical Center

Condition: Condition - Patients with benign uterine diseases undergoing transvaginal natural orifice transluminal endoscopic surgery (vNOTES) hysterectomy Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The aim of this study is to evaluate whether the use of a paracervical block (PCB) in vaginally assisted natural orifice transluminal endoscopic surgery hysterectomy (VANH) reduces postoperative pain and the consumption of analgesics. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - PCB with lidocaine (total 10 mL) Interventions/Control_2 - PCB with normal saline (total 10 mL) as placebo

Eligibility: Age-lower limit - 20 years-old = Gender - Female Key inclusion criteria - Patients scheduled to undergo VANH who have received a written explanation of the study and provided informed consent prior to surgery. Key exclusion criteria - Patients who did not provide informed consent Patients with a history of hypersensitivity to local anesthetics Patients with contraindications to general anesthesia (ASA-PS >= 3) Patients with moderate to severe renal dysfunction (eGFR <= 50 mL/min/1.73 m2) Patients with severe hepatic dysfunction (Child-Pugh class B or C) Patients with chronic opioid use prior to surgery Patients with psychiatric or cognitive conditions that may interfere with reliable VAS assessment Patients deemed unsuitable for participation by the principal investigator Target Size - 40

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2026 Year 04 Month 21 Day Date of IRB - 2026 Year 03 Month 26 Day Anticipated trial start date - 2026 Year 04 Month 21 Day Last follow-up date - 2027 Year 05 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070183

Disclaimer: Curated by HT Syndication.