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

Effect of Perioperative Continuous Intravenous Infusion of Esketamine and Lidocaine on Postoperative Chronic Pain and Long-term Survival in Patients Undergoing Hepatectomy

This study is testing if a combination of esketamine and lidocaine can help reduce pain and improve survival for people having liver surgery for cancer compared to standard pain relief methods.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 304 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: West China Hospital (Academic / other)
• Locations: 1 site (Chengdu, Sichuan)
• Trial ID: NCT06778460 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 scheduled for elective hepatectomy with ASA grades I-III.

Not a fit: Patients with severe cardiac or hepatic insufficiencies, or those with a history of long-term opioid abuse may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce chronic pain and improve long-term survival for patients undergoing liver surgery.

How similar studies have performed: Other studies have shown promising results with similar analgesic approaches, suggesting potential for success in this trial.

Eligibility criteria

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 this trial is running

Chengdu, Sichuan

• West China Hospital — Chengdu, Sichuan, China (Recruiting)

Study contacts

• Study coordinator: Chunling Jiang, PhD

Conditions Postoperative Chronic Pain