Using lidocaine to manage chronic pain after liver surgery
Effect of Prolonging Intravenous Lidocaine on Chronic Pain and Long-term Quality of Life in Patients Undergoing Hepatectomy
This study is testing if giving lidocaine during liver cancer surgery can help patients manage chronic pain and improve their recovery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 260 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | West China Hospital Academic / other |
| Locations | 1 site (Chengdu, Sichuan) |
| Trial ID | NCT05492669 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effects of long-term intravenous lidocaine infusion on postoperative chronic pain, quality of life, and survival rates in patients undergoing liver cancer surgery. A total of 272 patients will be randomly assigned to receive either lidocaine or a placebo during their surgical procedure. Pain management will be assessed using a numeric rating scale at various postoperative intervals, and blood samples will be collected to measure lidocaine levels and inflammatory factors. The goal is to determine if lidocaine can improve outcomes for patients recovering from liver surgery.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-80 with primary hepatocellular carcinoma scheduled for liver resection surgery.
Not a fit: Patients with severe hepatic or renal dysfunction, or those with other significant health issues, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce chronic pain and improve quality of life for patients after liver surgery.
How similar studies have performed: Previous studies have shown promising results with lidocaine for pain management, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Age: 18-80 years old American Society of Anesthesiologists(ASA) Ⅰ～III BMI≤30 Primary single hepatocellular carcinoma resection was proposed for patients undergoing laparotomy (median incision, right subcostal incision/inverted L-shaped incision) Exclusion Criteria: Primary liver cancer with malignant tumors of other organs (such as lung, kidney, intestine, etc.). Primary hepatocellular carcinoma with portal vein or inferior vena cava and other large vascular thrombus. Long-term opioid use, alcohol or drug abuse or any of the drugs (lidocaine, etc.) used in this study were contraindicated and allergic for patients. Patients with severe hepatic and renal dysfunction (total bilirubin \>1.46mg/dl, glomerular filtration rate \<30ml/min /1.73㎡ or end-stage renal disease). Severe heart disease (severe heart block (including sinoatrial, atrioventricular, and intraventricular block); Severe heart failure (ejection fraction \<20%); Sinus bradycardia; Patients with Adams-Stokes syndrome, preexcitation syndrome, etc Patients with a history of uncontrolled seizures or acute porphyria. Long-term use of cimetidine and β-blockers (lidocaine metabolism is inhibited through the liver, resulting in increased blood concentration of the drug, which can lead to adverse cardiac and nervous system reactions). Patients treated with drugs that are contraindicated with lidocaine (phenobarbital, thiopental, sodium nitroprusside, mannitol, amphotericin B, ampicillin, mesonotal, sulfadiazine sodium); Patients who are using enoxacin, lomefloxacin, norfloxacin, and prulifloxacin. Patients with a history of gastrointestinal bleeding or perforation after nsaids;Patients with active gastrointestinal ulcers/bleeding or who have had recurrent ulcers/bleeding in the past. Patients who had taken other experimental drugs or were participating or participating in other clinical trials within 3 months of enrollment. Failure to cooperate with the study for any reason or the researcher considers it inappropriate to be included in the study.
Where this trial is running
Chengdu, Sichuan
- West China Hospital — Chengdu, Sichuan, China (Recruiting)
Study contacts
- Study coordinator: Chunling Jiang, PhD
- Email: jiang_chunling@yahoo.com
- Phone: 18980601096
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.