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

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.

Study Overview

• Status: Completed
• Conditions: Bladder Cancer
• Intervention / Treatment: Procedure: general anesthesia; Procedure: general anesthesia combined with epidural analgesia

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200127
      • Renji Hospital, School of Medicine, Shanghai Jiaotong University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: RenJi Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 2, 2020
• Primary Completion (Actual): December 21, 2020
• Study Completion (Actual): January 21, 2021

Study Registration Dates

• First Submitted: April 19, 2020
• First Submitted That Met QC Criteria: April 21, 2020
• First Posted (Actual): April 24, 2020

Study Record Updates

• Last Update Posted (Actual): August 9, 2021
• Last Update Submitted That Met QC Criteria: August 1, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Opioid; Radical cystectomy; Epidural anesthesia; Circulating tumor cells
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Neoplasm Metastasis; Neoplastic Cells, Circulating; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: CTC20200417

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No