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Influence of Opioids on Circulating Tumor Cells in Radical Cystectomy

Shanghai Jiao Tong University logo

Shanghai Jiao Tong University

Status

Completed

Conditions

Bladder Cancer

Treatments

Procedure: general anesthesia combined with epidural analgesia
Procedure: general anesthesia

Study type

Interventional

Funder types

Other

Identifiers

NCT04358718
CTC20200417

Details and patient eligibility

About

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.

Enrollment

44 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

44 participants in 2 patient groups

general anesthesia
Active Comparator group
Description:
Patients in this group will receive general anesthesia with intraoperative and postoperative intravenous opioid-based analgesia.
Treatment:
Procedure: general anesthesia
general analgesia combined with epidural analgesia
Experimental group
Description:
Patients in this group will receive combined epidural and general anesthesia with intraoperative and postoperative epidural ropivacaine-based analgesia.
Treatment:
Procedure: general anesthesia combined with epidural analgesia

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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