Influence of Opioids on Circulating Tumor Cells in Radical Cystectomy

Study Overview
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Brief Summary
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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.

Official Title
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Influence of Peri-operative Opioids on Circulating Tumor Cells in Patients Undergoing Robot-Assisted Laparoscopic Radical Cystectomy

Conditions
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Bladder Cancer

Intervention / Treatment
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* Procedure: general anesthesia
* Procedure: general anesthesia combined with epidural analgesia


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: general anesthesia<br>Patients in this group will receive general anesthesia with intraoperative and postoperative intravenous opioid-based analgesia. | Procedure: general anesthesia<br>* Patients will receive intraoperative and postoperative intravenous opioid-based analgesia for robot-assisted laparoscopic radical cystectomy.<br>|
| Experimental: general analgesia combined with epidural analgesia<br>Patients in this group will receive combined epidural and general anesthesia with intraoperative and postoperative epidural ropivacaine-based analgesia. | Procedure: general anesthesia combined with epidural analgesia<br>* Patients will receive epidural ropivacaine-based analgesia for robot-assisted laparoscopic radical cystectomy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the number of circulating tumor cells | The number of circulating tumor cells will be measured by collecting 5ml of venous blood sample. | on the 3rd day after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the number of circulating tumor cells | The number of circulating tumor cells will be measured by collecting 5ml of venous blood sample. | immediately after the surgery | 
| the number of circulating tumor cells | The number of circulating tumor cells will be measured by collecting 5ml of venous blood sample. | on the 30 day after surgery | 
| Visual Analogue Scale | 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 24 hours after surgery. | at 24 hours after surgery | 
| Visual Analogue Scale | 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. | at 48 hours after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Circulating tumor cells, Opioid, Epidural anesthesia, Radical cystectomy