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Completed

NCT Number: NCT04358718

Influence of Opioids on Circulating Tumor Cells in 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.

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Key information

Conditions

Bladder Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Cells, Circulating Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Renji hospital, School of Medicine, Shanghai Jiaotong University

Shanghai, Shanghai Municipality, 200127, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

General Anesthesia

Procedure

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

general anesthesia combined with epidural analgesia

Procedure

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

Primary outcomes

  1. the number of circulating tumor cells

    Time frame: on the 3rd day after surgery

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

Secondary outcomes

  1. the number of circulating tumor cells

    Time frame: immediately after the surgery

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

  2. the number of circulating tumor cells

    Time frame: on the 30 day after surgery

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

  3. Visual Analogue Scale

    Time frame: 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.

  4. Visual Analogue Scale

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

RenJi Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Apr 24, 2020
Registry last updated
Aug 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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