Actively Recruiting
Effect of Perioperative Esketamine and Lidocaine Infusion on Postoperative Chronic Pain and Long-term Survival in Patients Undergoing Hepatectomy
Led by West China Hospital · Updated on 2025-01-16
304
Participants Needed
1
Research Sites
203 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a follow-up study on patients who previously participated in a related trial to evaluate the long-term effects of esketamine and lidocaine infusions on postoperative chronic pain, quality of life, and survival after hepatectomy. The study includes 304 patients with primary liver cancer to assess these outcomes in a systematic way. The main focus is to understand how these medications might influence chronic pain and survival rates over an extended period following liver surgery. Participants are randomly assigned to one of two groups: the esketamine-lidocaine group or the conventional analgesia (placebo) group. Those in the esketamine-lidocaine group receive doses of esketamine and lidocaine at anesthesia induction followed by continuous infusion during surgery. After surgery, they receive two pumps for 72 hours—one delivering a fixed-rate infusion of lidocaine and esketamine, and another containing sufentanil and granisetron. The placebo group receives normal saline instead of esketamine and lidocaine, along with the same postoperative pumps containing sufentanil and granisetron. During the study, pain is assessed using a numeric rating scale at 24, 48, and 72 hours after surgery. After discharge, patients are followed for up to 5 years to monitor chronic pain, its impact on quality of life, relapse-free survival, and overall survival. Researchers also observe the incidence of chronic pain at 3 months postoperatively. This thorough follow-up includes regular evaluations to understand long-term outcomes and safety.
CONDITIONS
Official Title
Effect of Esketamine and Lidocaine on Postoperative Chronic Pain and Long-term Survival in Patients Undergoing Hepatectomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18-75 years
- Scheduled for elective hepatectomy
- ASA grade I-III
You will not qualify if you...
- Patients intubated in ICU after surgery without planned extubation within 6 hours postoperatively
- Body weight under 40 kg or over 100 kg
- Cardiac conduction abnormalities (second- or third-degree atrioventricular block) or cardiac insufficiency with left ventricular ejection fraction below 50%
- Severe liver insufficiency with ALT, AST, or bilirubin levels more than 2.5 times the upper limit of normal
- Renal insufficiency with creatinine clearance under 60 mL/min
- Known allergy to esketamine or lidocaine
- History of long-term opioid abuse
- Unable to communicate effectively
- Serious medical conditions like uncontrolled hypertension, coronary heart disease, intracranial vascular malformations, or acute asthma attacks
- History of epilepsy or manic episodes
- Pregnant or breastfeeding women
- Glaucoma
- Preoperative cognitive dysfunction, bipolar disorder, or other psychiatric disorders including mental retardation
- Primary liver cancer with other malignant tumors or signs of distant metastasis
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Trial Site Locations
Total: 1 location
1
West China Hospital
Chengdu, Sichuan, China
Actively Recruiting
Research Team
C
Chunling Jiang, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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