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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| general anesthesia | Active Comparator | Patients in this group will receive general anesthesia with intraoperative and postoperative intravenous opioid-based analgesia. |
|
| general analgesia combined with epidural analgesia | Experimental | Patients in this group will receive combined epidural and general anesthesia with intraoperative and postoperative epidural ropivacaine-based analgesia. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| general anesthesia | Procedure | Patients will receive intraoperative and postoperative intravenous opioid-based analgesia for robot-assisted laparoscopic radical cystectomy. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Renji hospital, School of Medicine, Shanghai Jiaotong University | Shanghai | Shanghai Municipality | 200127 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36739595 | Derived | Wang X, Zhang S, Jin D, Luo J, Shi Y, Zhang Y, Wu L, Song Y, Su D, Pan Z, Chen H, Cao M, Yang C, Yu W, Tian J. mu-opioid receptor agonist facilitates circulating tumor cell formation in bladder cancer via the MOR/AKT/Slug pathway: a comprehensive study including randomized controlled trial. Cancer Commun (Lond). 2023 Mar;43(3):365-386. doi: 10.1002/cac2.12408. Epub 2023 Feb 5. |
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| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| D009360 | Neoplastic Cells, Circulating |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000768 | Anesthesia, General |
| D015360 | Analgesia, Epidural |
| ID | Term |
|---|---|
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
| D000698 | Analgesia |
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| general anesthesia combined with epidural analgesia | Procedure | Patients will receive epidural ropivacaine-based analgesia for robot-assisted laparoscopic radical cystectomy. |
|
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 |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D009362 | Neoplasm Metastasis |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |