Tokyo, Sept. 5 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062826) titled 'Effects of Paravertebral Block Timing and Dexamethasone as an Adjuvant on Postoperative Analgesia After Thoracoscopic Surgery: A Randomized Single-Blind 2x2 Factorial Trial' on Sept. 4.
Study Type:
Interventional
Study Design:
Basic Design - Factorial
Randomization - Randomized
Blinding - Single blind -participants are blinded
Control - No treatment
Primary Sponsor:
Institute - Gifu University
Condition:
Condition - Acute postoperative pain after thoracoscopic surgery for lung cancer, mediastinal tumors, and other thoracic diseases
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
Narrative objectives1 - The objective of this study is to determine whether the addition of dexamethasone to ropivacaine for paravertebral block prolongs postoperative analgesia and reduces rebound pain in patients undergoing thoracoscopic surgery. The study also aims to compare the analgesic effects of paravertebral block performed before versus after surgery and to identify an optimal perioperative analgesic strategy for thoracic surgery.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Paravertebral block is performed before surgery using 30 mL of 0.3% ropivacaine without dexamethasone.
Interventions/Control_2 - Paravertebral block is performed before surgery using 30 mL of 0.3% ropivacaine with 3.3 mg of dexamethasone.
Eligibility:
Age-lower limit - 18
years-old
=
Gender - Male and Female
Key inclusion criteria - Patients aged 18 to 75 years undergoing unilateral thoracoscopic surgery at Gifu University Hospital.
Patients with American Society of Anesthesiologists Physical Status (ASA-PS) 1-3.
Patients who provide written informed consent to participate in the study.
Key exclusion criteria - Patients with severe coagulation abnormalities.
Patients with a body mass index of 35 kg/m2 or greater.
Patients with diabetes mellitus and a random blood glucose level of 200 mg/dL or greater, or an HbA1c level of 7.3% or greater.
Patients with chronic pain currently requiring treatment.
Patients already receiving opioid analgesic therapy.
Patients unable to complete the study questionnaires.
Patients with cognitive impairment.
Patients considered inappropriate for participation by the investigator.
Target Size - 200
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 03 Month 20 Day
Date of IRB - 2026 Year 03 Month 24 Day
Anticipated trial start date - 2026 Year 10 Month 01 Day
Last follow-up date - 2029 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071913
Disclaimer: Curated by HT Syndication.