Influence of Opioids on Circulating Tumor Cells in Radical Cystectomy
- Conditions
- Bladder Cancer
- Registration Number
- NCT04358718
- Lead Sponsor
- RenJi Hospital
- Brief Summary
Multiple lines of evidence have shown that perioperative opioids requirement was associated with poor outcomes in cancer patients, including increased cancer progression and metastases and reduced survival in patients with lung, breast, prostate, and bladder cancer. Circulating tumor cells (CTCs) have been validated as prognostic biomarkers of a number of cancers. The aim of this study is to investigate the effects of perioperative opioids on the number of CTCs in patients receiving robot-assisted laparoscopic radical cystectomy. The difference of the amounts of perioperative opioids is achieved by using general anesthesia combined with intravenous opioid-based analgesia intra- and post-operatively in one group and general analgesia combined with epidural ropivacaine-based analgesia in the other group.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 44
- Age >=18
- ASA I-II
- Patients with primary bladder cancer of Stage T2a or higher, who are scheduled for robot-assisted laparoscopic radical cystectomy
- Written informed consent
- Emergency surgery
- Palliative surgery
- Contraindications for epidural anesthesia
- Metastatic bladder cancer
- Patients with a history of any other malignancy
- Chronic opioids medication
- severe systemic disease (heart, lung, kidney, or immune system)
- Known hypersensitivity or suspected allergy to intervention drugs
- Intellectual Disability
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method the number of circulating tumor cells on the 3rd day after surgery The number of circulating tumor cells will be measured by collecting 5ml of venous blood sample.
- Secondary Outcome Measures
Name Time Method the number of circulating tumor cells on the 30 day after surgery The number of circulating tumor cells will be measured by collecting 5ml of venous blood sample.
Visual Analogue Scale at 48 hours after surgery Pain intensity will be assessed using the Visual Analogue Scale, which ranges from 0 to 10, with a higher score indicating greater pain intensity at 48 hours after surgery.
Trial Locations
- Locations (1)
Renji hospital, School of Medicine, Shanghai Jiaotong University
🇨🇳Shanghai, Shanghai, China
Renji hospital, School of Medicine, Shanghai Jiaotong University🇨🇳Shanghai, Shanghai, China