Influence of Opioids on Circulating Tumor Cells in Radical Cystectomy

Not Applicable

Completed

• Conditions: Bladder Cancer
• Interventions: Procedure: general anesthesia combined with epidural analgesia; Procedure: general anesthesia

• 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

Study Timeline

• Study First Submitted: 2020-04-19
• Study First Submitted QC: 2020-04-21
• Study First Posted: 2020-04-24
• Study Start: 2020-06-02
• Primary Completion: 2020-12-21
• Study Completion: 2021-01-21
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-01
• Last Update Posted: 2021-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Arm && Interventions

Group	Intervention	Description
general analgesia combined with epidural analgesia	general anesthesia combined with epidural analgesia	Patients in this group will receive combined epidural and general anesthesia with intraoperative and postoperative epidural ropivacaine-based analgesia.
general anesthesia	general anesthesia	Patients in this group will receive general anesthesia with intraoperative and postoperative intravenous opioid-based analgesia.

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