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Influence of Opioids on Circulating Tumor Cells in Radical Cystectomy

Primary Purpose

Bladder Cancer

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
general anesthesia
general anesthesia combined with epidural analgesia
Sponsored by
RenJi Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Bladder Cancer focused on measuring Circulating tumor cells, Opioid, Epidural anesthesia, Radical cystectomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Renji hospital, School of Medicine, Shanghai Jiaotong University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

general anesthesia

general analgesia combined with epidural analgesia

Arm Description

Patients in this group will receive general anesthesia with intraoperative and postoperative intravenous opioid-based analgesia.

Patients in this group will receive combined epidural and general anesthesia with intraoperative and postoperative epidural ropivacaine-based analgesia.

Outcomes

Primary Outcome Measures

the number of circulating tumor cells
The number of circulating tumor cells will be measured by collecting 5ml of venous blood sample.

Secondary Outcome Measures

the number of circulating tumor cells
The number of circulating tumor cells will be measured by collecting 5ml of venous blood sample.
the number of circulating tumor cells
The number of circulating tumor cells will be measured by collecting 5ml of venous blood sample.
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.
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.

Full Information

First Posted
April 19, 2020
Last Updated
August 1, 2021
Sponsor
RenJi Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04358718
Brief Title
Influence of Opioids on Circulating Tumor Cells in Radical Cystectomy
Official Title
Influence of Peri-operative Opioids on Circulating Tumor Cells in Patients Undergoing Robot-Assisted Laparoscopic Radical Cystectomy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
June 2, 2020 (Actual)
Primary Completion Date
December 21, 2020 (Actual)
Study Completion Date
January 21, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
RenJi Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer
Keywords
Circulating tumor cells, Opioid, Epidural anesthesia, Radical cystectomy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
general anesthesia
Arm Type
Active Comparator
Arm Description
Patients in this group will receive general anesthesia with intraoperative and postoperative intravenous opioid-based analgesia.
Arm Title
general analgesia combined with epidural analgesia
Arm Type
Experimental
Arm Description
Patients in this group will receive combined epidural and general anesthesia with intraoperative and postoperative epidural ropivacaine-based analgesia.
Intervention Type
Procedure
Intervention Name(s)
general anesthesia
Intervention Description
Patients will receive intraoperative and postoperative intravenous opioid-based analgesia for robot-assisted laparoscopic radical cystectomy.
Intervention Type
Procedure
Intervention Name(s)
general anesthesia combined with epidural analgesia
Intervention Description
Patients will receive epidural ropivacaine-based analgesia for robot-assisted laparoscopic radical cystectomy.
Primary Outcome Measure Information:
Title
the number of circulating tumor cells
Description
The number of circulating tumor cells will be measured by collecting 5ml of venous blood sample.
Time Frame
on the 3rd day after surgery
Secondary Outcome Measure Information:
Title
the number of circulating tumor cells
Description
The number of circulating tumor cells will be measured by collecting 5ml of venous blood sample.
Time Frame
immediately after the surgery
Title
the number of circulating tumor cells
Description
The number of circulating tumor cells will be measured by collecting 5ml of venous blood sample.
Time Frame
on the 30 day after surgery
Title
Visual Analogue Scale
Description
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.
Time Frame
at 24 hours after surgery
Title
Visual Analogue Scale
Description
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.
Time Frame
at 48 hours after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Renji hospital, School of Medicine, Shanghai Jiaotong University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200127
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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Influence of Opioids on Circulating Tumor Cells in Radical Cystectomy

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