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RECRUITING

NCT05492669

PHASE2

Intravenous Lidocaine on Chronic Pain in Patients Undergoing Hepatectomy

Sponsor: West China Hospital

View on ClinicalTrials.gov

Summary

This study is a further observation and follow-up of the patients enrolled in the registration number NCT04295330 to further evaluate the effect of long-term infusion of lidocaine on postoperative chronic pain, long-term quality of life and survival rate in patients undergoing liver cancer surgery.

Official title: Effect of Prolonging Intravenous Lidocaine on Chronic Pain and Long-term Quality of Life in Patients Undergoing Hepatectomy

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

260

Start Date

2020-02-27

Completion Date

2024-07-27

Last Updated

2024-04-19

Healthy Volunteers

Conditions

Postoperative Chronic Pain

Interventions

DRUG

Lidocaine Hydrochloride, Injectable

In the lidocaine group, at the end of the induction of general anesthesia, a bolus injection of lidocaine 1.5 mg/kg, calculated using the patient's ideal body weight and given as an infusion over 10 minutes, followed by a continuous infusion of lidocaine at 1.5 mg/kg per hour for the whole surgical procedure and will be discontinued at the end of surgery. Postoperative pain management during the first 72 postoperative hours will involve the use of a PCIA device, which will contain lidocaine 30mg/kg, sufentanil 2 μg/kg, granisetron 12 mg diluted to 200 mL in 0.9 % normal saline.

DRUG

0.9% normal saline

In the placebo group, the same volume of normal saline will be administered during anesthesia. The postoperative PCIA device will contain sufentanil 2 μg/kg, granisetron 12 mg diluted to 200 mL in 0.9% normal saline solution with a total volume of 200 ml.

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.

Locations (1)

West China Hospital

Chengdu, Sichuan, China