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Randomized controlled clinical study on the effect of general anesthesia combined with bupivacaine liposome transversus abdominis plane block on tumor recurrence after robot assisted laparoscopic radical prostatectomy

Randomized controlled clinical study on the effect of general anesthesia combined with bupivacaine liposome transversus abdominis plane block on tumor recurrence after robot assisted laparoscopic radical prostatectomy

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500102843
Enrollment
Unknown
Registered
2025-05-21
Start date
2025-05-25
Completion date
Unknown
Last updated
2025-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tumor recurrence rate after radical prostatectomy for prostate cancer

Interventions

Experimental group:General anesthesia combined with bupivacaine liposome TAP block, with fentanyl added as appropriate during surgery based on the patients response to surgical stimuli
Control group: General anesthesia without combination of bupivacaine liposome TAP block, with intermittent addition of fentanyl as needed during surgery

Sponsors

Huashan Hospital Affiliated to Fudan University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
40 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Prostate cancer patients voluntarily agree to robot assisted laparoscopic radical prostatectomy; 2.The diagnostic criteria for limited prostate cancer patients undergoing robot assisted laparoscopic radical prostatectomy are determined in accordance with the "Chinese Urology and Andrology Disease Diagnosis and Treatment Guidelines 2022 Edition" published by the Chinese Medical Association; 3.Preoperative prostate biopsy to identify prostate cancer patients; 4.According to the AJCC guidelines for staging recommendations, prostate cancer patients withT=<2, N0M0, and PSA=< 20ng/ml should be selected; 5.Preoperative screening of patients who do not require further treatment after surgery based on imaging examinations and prostate-specific antigen results; 6.Age range from 40 to 75 years old; 7.ASA grade 1-3, without severe complications of important organs such as heart, lung, liver, and kidney; 8.Study participants voluntarily used postoperative analgesia pumps; 9.Research participants voluntarily sign informed consent forms.

Exclusion criteria

Exclusion criteria: 1.Patients who cannot remove the tracheal tube after surgery and are transferred to the ICU; 2.Previous endocrine therapy or chemotherapy; 3.Preoperative imaging examinations (using magnetic resonance imaging to evaluate lymph node and visceral metastasis, and bone scanning to evaluate bone metastasis) indicate bone metastasis, distant lymph node metastasis, and visceral metastasis; 4.Patients with intraoperative blood loss exceeding 800ml.

Design outcomes

Primary

MeasureTime frame
Survival time of patients without biochemical recurrence after radical prostatectomy;

Secondary

MeasureTime frame
No imaging progression recurrence rate, perioperative opioid use, incidence of postoperative complications, and all-cause mortality rate of prostate cancer;

Countries

China

Contacts

Public ContactQu Yu

Huashan Hospital Affiliated to Fudan University

yu.qiong816@qq.com+86 134 7275 5168

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026