Tokyo, Nov. 13 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059744) titled 'To verify the analgesic effect of intraoperative pulsed radiofrequency therapy during thoracic surgery to alleviate postoperative pain' 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. Lukes International University
Condition:
Condition - Lung cancer, Mediastinum tumor, Pneumothorax, Chest wall tumor, Valvular heart disease
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To reduce postoperative pain without adverse effects and to decrease the amount of postoperative analgesics used by performing Pulsed Radiofrequency (PRF), which has been reported to have safety and analgesic efficacy, during the perioperative period in patients undergoing respiratory and cardiovascular surgery.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Group Receiving PRF During Surgery
Interventions/Control_2 - Conventional Pain Management Group
Eligibility:
Age-lower limit - 18
years-old
Gender - Male and Female
Key inclusion criteria - Inclusion Criteria for the Study Group:
Individuals deemed suitable for thoracoscopic, robot-assisted thoracoscopic, or open thoracic surgery.
Age between 18 and 84 years at the time of consent.
Written informed consent has been obtained from the individual for participation in the study.
Criteria for the Control Group:
Individuals who underwent thoracoscopic, robot-assisted thoracoscopic, or open thoracic surgery at our hospital between April 2023 and March 2024.
Key exclusion criteria - Exclusion Criteria for the Study Group:
Individuals with a pacemaker that may cause electrical interference.
Women who are pregnant, breastfeeding, or have the possibility of pregnancy.
Individuals deemed inappropriate for the study by the principal investigator or co-investigators.
Exclusion Criteria for the Control Group:
Individuals who have submitted a statement of non-participation.
Target Size - 290
Recruitment Status:
Recruitment status - Open public recruiting
Date of protocol fixation - 2024 Year 08 Month 23 Day
Date of IRB - 2024 Year 09 Month 09 Day
Anticipated trial start date - 2024 Year 10 Month 01 Day
Last follow-up date - 2026 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063344
Disclaimer: Curated by HT Syndication.