Intravenous Lidocaine on Chronic Pain in Patients Undergoing Hepatectomy

Phase 2RecruitingNCT05492669

West China Hospital260 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

260

Conditions

Postoperative Chronic Pain

Interventions

Lidocaine Hydrochloride, InjectableDRUG

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.

0.9% normal salineDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

RECRUITING

Outcomes

Primary Outcomes

The incidence of chronic pain at 3 months postoperatively

Chronic pain is defined as pain that lasts or recurs for longer than 3 months. For chronic postsurgical pain(CPSP), it mainly refers to the pain that persists past normal healing time. Pain scoring is performed at 3 months using the Numerical Rating Scale(NRS), with 11 digits ranging from 0 to 10 indicating the degree of pain,0 indicating no pain, and 10 indicating severe pain. Subjects choose a number to indicate the degree of pain based on their personal pain experience. The impact of chronic pain on the quality of life is also assessed by Brief Pain Inventory score.

Time frame: 3 months postoperatively

Secondary Outcomes

The incidence of chronic pain at 6 months ,1 year,3 year and 5 year postoperatively

Time frame: 6 months, 1 year and 3 year postoperatively

The levels of inflammatory factors at 24 hours after surgery

Peripheral blood TNF-α, CXCL10, cytokines IL-6, three tumor progressions and metastasis-related markers (VEGF-A,MMP-3, MMP-9,MMP-2) etc. are measured 24 hours after operation.

Time frame: 24 hours postoperatively

The incidence of moderate to severe pain at 24, 48 and 72 hours after surgery at rest and during movement;

The pain is evaluated using numerical rating scale（NRS). NRS scores range from 0 to 10 points, with 0 points representing no pain, 1-3 points representing mild pain, 4-6 points representing moderate pain, 7-9 points representing severe pain and 10 points.

Central Contacts

Chunling Jiang, PhD

CONTACT

18980601096 jiang_chunling@yahoo.com

Data from ClinicalTrials.gov

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