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Efficacy and Safety of Ultrasound-Guided Thoracic Paravertebral Block for Reducing Bleeding During Laparoscopic Hepatectomy: A Prospective, Randomized, Open-Label, Multicenter Study

Efficacy and Safety of Ultrasound-Guided Thoracic Paravertebral Block for Reducing Bleeding During Laparoscopic Hepatectomy: A Prospective, Randomized, Open-Label, Multicenter Study

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600116065
Enrollment
Unknown
Registered
2026-01-05
Start date
2026-01-11
Completion date
Unknown
Last updated
2026-01-12

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

Conditions

Liver tumor

Interventions

Test group:Bilateral thoracic paravertebral block combined with fluid-restricted controlled low central venous pressure general anesthesia
Control group:General anesthesia using vasoactive drugs and fluid restriction to maintain controlled low central venous pressure

Sponsors

Fuzhou University Affiliated Provincial Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Male or female individuals aged between 18 and 70 years old. 2. Body Mass Index (BMI) within the range of [18.0 - 30.0] kg/m² (including the critical value). 3. Diagnosed clinically or pathologically as hepatocellular carcinoma and planned to undergo laparoscopic liver resection. 4. American Society of Anesthesiologists (ASA) classification is I-II. 5. Single tumor located in the right liver (V, VI, VII or VIII segment), with a tumor diameter of 4-8 cm. 6. The expected resection range involves at least one liver segment. 7. No cancerous portal vein or hepatic vein thrombosis. 8. Indocyanine Green 15-minute retention rate (ICGR15) = 80 points. 11. Liver function Child-Pugh classification is A grade. 12. Acceptable coagulation function: INR = 70 × 10?/L, prothrombin activity >= 60%. 13. Voluntary participation in this study and signing a written informed consent.

Exclusion criteria

Exclusion criteria: 1. There is extrahepatic metastasis. 2. There is a history of open surgery in the upper abdomen. 3. Those who plan to undergo other surgeries at the same time. 4. There is coagulation dysfunction (excluding the criteria in item 11), with an international normalized ratio > 1.5 - 2.0, and cannot be effectively corrected through vitamin K or fresh frozen plasma. Platelet count = 450 ms, for females >= 470 ms (if the first abnormality is detected, it can be measured three times and averaged). 7. Pulmonary diseases: pneumoconiosis, acute respiratory tract infection, bronchiectasis, pulmonary hypertension, uncontrolled severe asthma, severe chronic obstructive pulmonary disease or interstitial lung disease, accompanied by respiratory failure at rest (PaO2 50 mmHg). 8. Renal insufficiency (serum creatinine > 2 mg/dL or requiring dialysis). 9. Severe electrolyte disorders (such as hypokalemia, hyponatremia) and acidosis. 10. Uncontrolled hypertension (continuous 2 or more measurements of resting sitting systolic blood pressure >= 160 mmHg, or diastolic blood pressure >= 100 mmHg). 11. History of local anesthetic allergy. 12. Spinal surgery history, spinal curvature, skin infection at the puncture site. 13. Patients who cannot cooperate with paravertebral block. 14. Patients with poor compliance, impaired mental state or language communication disorders. 15. Patients and their families refuse to accept necessary intraoperative monitoring and invasive procedures (such as arterial puncture, central venous puncture, etc.). 16. (Note: Hepatectomy combined with cholecystectomy is not an exclusion criterion.)

Design outcomes

Primary

MeasureTime frame
The proportion of patients with a liver surgery wound bleeding score of =<=2 points;

Secondary

MeasureTime frame
Time of liver parenchyma resection (minutes);Portal vein occlusion/opening cycle (minutes): Duration of each Pringle method occlusion;Total blood loss during the operation (ml);Whether blood transfusion is required and the volume of blood transfusion (in milliliters);Usage of vasoactive drugs (types, doses);Riker's Sedation-Agitation Scale;Improved Aldrete Score;Blood lactate and hemoglobin values;Pain score;

Countries

China

Contacts

Public ContactDanfeng Wang

Fuzhou University Affiliated Provincial Hospital

ApplePai@fzu.edu.cn+86 139 0692 0551

Outcome results

None listed

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