Skip to content

Comparative Efficacy of Bupivacaine Liposome versus Ropivacaine and Dexamethasone for Postoperative Analgesia Following Robot-Assisted Mediastinal Tumor Resection

Comparative Efficacy of Bupivacaine Liposome versus Ropivacaine and Dexamethasone for Postoperative Analgesia Following Robot-Assisted Mediastinal Tumor Resection

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600124157
Enrollment
Unknown
Registered
2026-05-08
Start date
2025-02-04
Completion date
Unknown
Last updated
2026-05-11

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

Conditions

Mediastinal Tumor

Interventions

Liposomal bupivacaine group :Bupivacaine liposome group: Dilute 20 ml of bupivacaine liposome solution with 0.9% normal saline to a total volume of 30 ml. Using a 25G puncture needle under endoscopy,
ropivacaine with dexamethasone group:Ropivacaine combined with dexamethasone group: 10 ml of ropivacaine hydrochloride (75 mg) totaling 20 ml, diluted with 0.9% saline to a total volume of 30 ml, and

Sponsors

The Affiliated Hospital of Xuzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Chest CT with contrast enhancement demonstrates mediastinal masses, including tumors in the anterior, middle, or posterior mediastinum; 2. The mediastinal mass does not invade surrounding tissues such as the brachiocephalic vein, lungs, aorta, or phrenic nerve; 3. Age between 18 and 80 years (including the upper limit); 4. Informed consent is obtained with no communication barriers and the patient remains conscious; 5. Preoperative laboratory test results are within normal ranges, or surgery can be performed with medical authorization; 6. Preoperative physical examination confirms good physical condition to tolerate robotic-assisted mediastinal tumor resection. ASA (American College of Surgeons) scores range from I to III (indicating health status from healthy to moderate disease); 7. No severe chest or abdominal conditions such as acute pleurisy or serious gastrointestinal disorders.

Exclusion criteria

Exclusion criteria: 1. Patients with coagulation disorders or hemoglobin levels < 70 g/L; 2. Those requiring intraoperative thoracotomy; 3. History of mediastinal surgery; 4. Pain medication dependence; 5. Chronic pain history or neurological conditions; 6. Impaired cardiac, hepatic, or renal function; 7. Anesthesia drug allergy; 8. Active infections (e.g., pneumonia) or uncontrolled medical conditions (e.g., diabetic ketoacidosis, gastrointestinal obstruction); 9. Researcher-identified unstable or potentially unsafe conditions affecting participant safety and study compliance; 10. Allergies to investigational drugs/adjuvants or prior severe adverse reactions; 11. Patients with severe mental disorders that may impair study participation.

Design outcomes

Primary

MeasureTime frame
Resting NRS pain score at 24 hours postoperatively;

Secondary

MeasureTime frame
The Numerical Rating Scale (NRS) was used to assess pain scores during activity at 24 hours postoperatively.;operation time;blood loss during operation;intraoperative sufentanil consumption;intraoperative remifentanil consumption;NRS score at rest at 12 hours postoperatively;NRS score on movement at 12 hours postoperatively;NRS score at rest at 48 hours postoperatively;NRS score on movement at 48 hours postoperatively;NRS score at rest at 72 hours postoperatively;NRS score on movement at 72 hours postoperatively;Time to first rescue analgesic administration within 72 hours postoperatively;postoperative drainage volume; time to chest tube removal;Time to first ambulation after surgery;Total postoperative hospital stay;Time to first PCIA bolus;Sufentanil consumption within 24 hours postoperatively;Sufentanil consumption within 48 hours postoperatively;Quality of Recovery score on postoperative day 1;Quality of Recovery score on postoperative day 2;Quality of Recovery score on postoperative day 3;Quality of Recovery score on postoperative day 7;

Countries

China

Contacts

Public ContactHao Zhang

The Affiliated Hospital of Xuzhou Medical University

Zhanghao@xzhmu.edu.cn+86 177 9883 5177

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 16, 2026