Influence of Opioids on Circulating Tumor Cells in Radical Cystectomy

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04358718

Enrollment

Registered

2020-04-24

Start date

2020-06-02

Completion date

2021-01-21

Last updated

2021-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder Cancer

Keywords

Circulating tumor cells, Opioid, Epidural anesthesia, Radical cystectomy

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.

Interventions

PROCEDUREgeneral anesthesia

Patients will receive intraoperative and postoperative intravenous opioid-based analgesia for robot-assisted laparoscopic radical cystectomy.

PROCEDUREgeneral anesthesia combined with epidural analgesia

Patients will receive epidural ropivacaine-based analgesia for robot-assisted laparoscopic radical cystectomy.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
the number of circulating tumor cells	immediately after the surgery	The number of circulating tumor cells will be measured by collecting 5ml of venous blood sample.
Visual Analogue Scale	at 24 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 24 hours after surgery.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026