Effects of esketamine and lidocaine on pain and survival after liver surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the long-term effects of esketamine and lidocaine on postoperative chronic pain, quality of life, and survival rates in patients undergoing hepatectomy for primary liver cancer. A total of 304 patients will be randomly assigned to receive either the esketamine-lidocaine treatment or a conventional analgesia regimen. The treatment group will receive a continuous infusion of esketamine and lidocaine during and after surgery, while the control group will receive a placebo. Pain levels will be assessed using a numeric rating scale at various postoperative intervals, and follow-up will track chronic pain and survival outcomes over five years.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Aged 18-75 years;
2. Scheduled for elective hepatectomy;
3. ASA grade I-III.

Exclusion Criteria:

1. Patients who have been intubated in the ICU following surgery and do not have a planned extubation within 6 hours postoperatively.
2. Patients with a body weight less than 40 kg or greater than 100 kg.
3. Patients with cardiac conduction system abnormalities (second- or third-degree atrioventricular block) or cardiac insufficiency (left ventricular ejection fraction \< 50%).
4. Patients with severe hepatic insufficiency (alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\], or bilirubin levels more than 2.5 times the upper limit of normal) or renal insufficiency (creatinine clearance rate \< 60 mL/min).
5. Patients with a known hypersensitivity to the investigational drug.
6. Patients with a history of long-term opioid abuse.
7. Patients who are unable to communicate effectively.
8. Patients with serious comorbid medical conditions, such as uncontrolled hypertension, coronary heart disease, intracranial vascular malformations, or acute asthma exacerbations.
9. Patients with a history of epilepsy or a history of manic episodes.
10. Pregnant or breastfeeding women.
11. Patients with glaucoma.
12. Patients with preoperative cognitive dysfunction, bipolar disorder, or other psychiatric disorders, including mental retardation.
13. Patients with primary liver cancer in conjunction with malignant tumors of other organs (such as lung, kidney, intestine, etc.), or those with clinical symptoms or imaging findings suggestive of distant metastasis.

Where it's running

• West China Hospital
  Chengdu, Sichuan, China Recruiting

Study contacts

• Study coordinator: Chunling Jiang, PhD
• Email: jiang_chunling@yahoo.com
• Phone: 18980601096

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.