Clinical trial NCT05492669: Intravenous Lidocaine on Chronic Pain in Patients Undergoing Hepatectomy
Official title: Effect of Prolonging Intravenous Lidocaine on Chronic Pain and Long-term Quality of Life in Patients Undergoing Hepatectomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Postoperative Chronic Pain
Keywords: lidocaine
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2022-08-08
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The experimental group received lidocaine and the control group received the same amount of saline.
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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. 272 patients with primary liver cancer who meet the inclusion criteria are included. According to the random number, the patients are divided into lidocaine group and conventional analgesia group.In the lidocaine group, a bolus injection of lidocaine 1.5 mg/kg, 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 , sufentanil , granisetron diluted to 200 mL in 0.9 % normal saline. In the placebo group, the same volume of normal saline instead of lidocaine will be administered. Blood samples will be drawn immediately after the bolus infusion of lidocaine, at the end of surgery, and 24 hours after surgery to measure plasma lidocaine concentrations. Blood samples will also be collected at 24 hours after surgery for subsequent measurement of inflammatory factors. Numeric rating scale(NRS) is used to evaluate pain at rest and light activities at postoperative 24, 48, 72 hours. The recovery time of postoperative gastrointestinal function, length of hospital stay, and the incidence of lidocaine toxicity within postoperative 72 hours will be recorded. Follow-up after discharge includes chronic pain, the impact of chronic pain on quality of life, the relapse-free survival and overall survival from postoperative 3 months to 5 years.

Eligibility 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.

Primary outcomes:
measure: The incidence of chronic pain at 3 months postoperatively
timeFrame: 3 months postoperatively
Secondary outcomes:
measure: The incidence of chronic pain at 6 months ,1 year,3 year and 5 year postoperatively
timeFrame: 6 months, 1 year and 3 year postoperatively
measure: The levels of inflammatory factors at 24 hours after surgery
timeFrame: 24 hours postoperatively
measure: The incidence of moderate to severe pain at 24, 48 and 72 hours after surgery at rest and during movement;
timeFrame: At 3 days after surgery
measure: The cumulative morphine consumption at 24, 48 and 72 hours postoperatively
timeFrame: At the end of the surgery，24，48 and 72 hours after surgery
measure: The incidence of a composite of postoperative pulmonary complications during
timeFrame: during the period from the end of surgery to discharge
measure: Length of hospital stay
timeFrame: during the period from the end of surgery to discharge
measure: Plasma lidocaine concentration immediately after loading，after surgery and 24-hours postoperatively
timeFrame: Immediately after bolus, after surgery and 24-hour postoperatively
measure: The incidence of lidocaine toxicity within 72 hours after operation
timeFrame: within 72 hours after operation
measure: Overall survival after surgery
timeFrame: 6 months, 1 year, 3 years, 5 years postoperatively
measure: Recurrence-free survival after surgery
timeFrame: 6 months, 1 year, 3 years, 5 years postoperatively
measure: Disability-free surviva survival
timeFrame: 6 months, 1 year, 3 years, 5 years postoperatively
Other outcomes:
measure: The prevalence of neuropathic pain
timeFrame: 3 months, 6 months, 1 year, 3 years, 5 years postoperatively
Locations:
city: Chengdu
country: China
facility: West China Hospital
state: Sichuan
Study officials:
affiliation: West China Hospital
name: Chunling Jiang, PhD
role: STUDY_DIRECTOR
References: