Tokyo, Nov. 13 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059742) titled 'Evaluation of the analgesic effect of adding intraoperative pulsed radiofrequency therapy to conventional perioperative pain management' on Nov. 12.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Non-randomized Blinding - Open -no one is blinded Control - No treatment

Primary Sponsor: Institute - St. Luke's International University

Condition: Condition - post-thoracotomy pain Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - Intraoperative PRF, which has been reported to be safe and analgesic in addition to conventional analgesic methods in the perioperative period of respiratory surgery, is intended to reduce postoperative pain without side effects and to reduce the use of analgesics in the postoperative period. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Groups that add intraoperative PRF to conventional pain management Interventions/Control_2 - Conventional pain management group

Eligibility: Age-lower limit - 18 years-old

Gender - Male and Female Key inclusion criteria - The intervention group will include those who meet all of the following criteria 1) Patients deemed appropriate to undergo thoracoscopic or robotic-assisted thoracoscopic surgery. 2) Have a resectable pulmonary lesion. 3) Are between the ages of 18 and 85 years at the time consent is obtained. 4) Have obtained written consent from the individual to participate in this study. Key exclusion criteria - The intervention group will not include in the study any of the following 1) Patients who take analgesics as their regular medication. 2) Patients who undergo resection other than lung lesions at the same time 3) Patients with renal dysfunction (eGFR 50) 4) Patients who cannot take NSAIDs due to allergy, etc. 5) Patients with implanted pacemakers that may cause electrical interference 6) Patients who require open chest surgery due to bleeding or severe adhesions 7) Women who are lactating, pregnant, or may become pregnant 8) Other subjects deemed inappropriate by the principal investigator (co-investigator). Target Size - 230

Recruitment Status: Recruitment status - Completed Date of protocol fixation - 2024 Year 06 Month 05 Day Date of IRB - 2024 Year 05 Month 27 Day Anticipated trial start date - 2024 Year 06 Month 05 Day Last follow-up date - 2025 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062954

Disclaimer: Curated by HT Syndication.