To Explore the Safety and Efficacy of Intravenous Infusion of Different Doses of Lidocaine in Patients

Study Overview
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Brief Summary
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All patients who met the inclusion criteria were randomly divided into four groups, 30 cases in each group, which were lidocaine group 1, lidocaine group 1.5, lidocaine group 2, and the placebo group In lidocaine group 1, lidocaine group 1.5, and lidocaine group 2, 1% lidocaine 1.5 mg/kg was intravenously infused with a micropump after anesthesia induction, and the infusion was completed within 10 minutes according to the ideal body weight, and then continued for 1% lidocaine was infused at 1 mg/kg.h, 1.5 mg/kg.h and 2 mg/kg.h respectively until the end of the operation. In the placebo group, the same volume of normal saline was used instead.

Detailed Description
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All patients who met the inclusion criteria were randomly divided into four groups, 30 cases in each group, which were lidocaine group 1, lidocaine group 1.5, lidocaine group 2, and the placebo group In lidocaine group 1, lidocaine group 1.5, and lidocaine group 2, 1% lidocaine 1.5 mg/kg was intravenously infused with a micropump after anesthesia induction, and the infusion was completed within 10 minutes according to the ideal body weight, and then continued for 1% lidocaine was infused at 1 mg/kg.h, 1.5 mg/kg.h and 2 mg/kg.h respectively until the end of the operation. In the placebo group, the same volume of normal saline was used instead.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. 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. All the background infusions of PCIA will set at 2 ml/h, the bolus volume of each PCIA press is 2 ml and the lockout interval is 15 min.

Official Title
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A Pilot Study on the Safety and Efficacy of Intravenous Infusion of Different Doses of Lidocaine for Postoperative Analgesia in Patients With Open Hepatectomy

Conditions
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Liver Cancer

Intervention / Treatment
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* Drug: Lidocaine Hydrochloride, Injectable


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 18-70 years old American Society of Anesthesiologists(ASA) Ⅰ～III BMI≤30 Intended for open liver resection Exclusion criteria：1. Long-term opioid users 2. Patients with contraindications or allergies to any drugs (lidocaine, etc.) used in this study 3. Patients with severe hepatic insufficiency before surgery (defined as total bilirubin>1.46mg/dl), renal insufficiency (glomerular filtration rate <30ml/min/1.73m2 or end-stage renal disease) 4. Associated with severe heart disease (second or third degree atrioventricular block); severe heart failure (ejection fraction <50%); sinus bradycardia; patient 6. Patients who participated in other clinical trials within 3 months before enrollment in the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The experimental patients are randomly divided into three groups and received different doses of lidocaine and the control group received the same amount of saline.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lidocaine 1 group<br>After induction of anesthesia, 1% lidocaine 1.5mg/kg (ideal body weight, 10min pumped) was injected intravenously with a micro pump, and then 1% lidocaine 1mg/kg.h (ideal body weight) was continuously pumped until the end of the operation , connected to patient-controlled intravenous analgesia (PCIA) pump containing lidocaine 0.3-1.5mg/kg.h after operation to 72h after operation. | Drug: Lidocaine Hydrochloride, Injectable<br>* The lidocaine group 1, 1.5 and 2 groups were injected with 1% lidocaine 1.5mg/kg (ideal body weight, 10min infusion) after anesthesia induction, respectively, and then continued to infuse 1% lidocaine. 1mg/kg.h, 1.5mg/kg.h, 2mg/kg.h (ideal body weight) until the end of the operation, and a patient-controlled intravenous analgesia (PCIA) pump containing lidocaine (PCIA) 0.3-1.5mg/kg after surgery. h to 72h after surgery.<br>|
| Experimental: Lidocaine 1.5 group<br>After induction of anesthesia, 1% lidocaine 1.5mg/kg (ideal body weight, 10min pumped) was injected intravenously with a micro pump, and then 1% lidocaine 1.5mg/kg.h (ideal body weight) was continuously pumped until the end of the operation , connected to patient-controlled intravenous analgesia (PCIA) pump containing lidocaine 0.3-1.5mg/kg.h after operation to 72h after operation. | Drug: Lidocaine Hydrochloride, Injectable<br>* The lidocaine group 1, 1.5 and 2 groups were injected with 1% lidocaine 1.5mg/kg (ideal body weight, 10min infusion) after anesthesia induction, respectively, and then continued to infuse 1% lidocaine. 1mg/kg.h, 1.5mg/kg.h, 2mg/kg.h (ideal body weight) until the end of the operation, and a patient-controlled intravenous analgesia (PCIA) pump containing lidocaine (PCIA) 0.3-1.5mg/kg after surgery. h to 72h after surgery.<br>|
| Experimental: Lidocaine 2 group<br>After induction of anesthesia, 1% lidocaine 1.5mg/kg (ideal body weight, 10min pumped) was injected intravenously with a micro pump, and then 1% lidocaine 2mg/kg.h (ideal body weight) was continuously pumped until the end of the operation , connected to patient-controlled intravenous analgesia (PCIA) pump containing lidocaine 0.3-1.5mg/kg.h after operation to 72h after operation. | Drug: Lidocaine Hydrochloride, Injectable<br>* The lidocaine group 1, 1.5 and 2 groups were injected with 1% lidocaine 1.5mg/kg (ideal body weight, 10min infusion) after anesthesia induction, respectively, and then continued to infuse 1% lidocaine. 1mg/kg.h, 1.5mg/kg.h, 2mg/kg.h (ideal body weight) until the end of the operation, and a patient-controlled intravenous analgesia (PCIA) pump containing lidocaine (PCIA) 0.3-1.5mg/kg after surgery. h to 72h after surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immediate postoperative plasma lidocaine concentration | Plasma lidocaine concentration is an important indicator for evaluating the safety of the drug during use | Immediately after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma lidocaine concentration immediately after loading | Plasma lidocaine concentration is an important indicator for evaluating the safety of the drug during use | 30 minutes before surgery | 
| 24-hour postoperative plasma lidocaine concentration | Plasma lidocaine concentration is an important indicator for evaluating the safety of the drug during use | 24-hour postoperative | 
| The incidence of lidocaine toxicity within 72 hours after operation | Lidocaine toxicity mainly includes neurological manifestations such as dizziness, tinnitus, convulsions, cardiac manifestations such as bradycardia, new severe atrioventricular block and so on. | within 72 hours after operation | 
| The incidence of moderate to severe pain at 24、48 and 72 hours after surgery at rest and during movement; | he 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 representing the strongest pain. | 24，48 and 72 hours after surgery | 
| The cumulative morphine consumption at 24, 48 and 72 hours postoperatively | intra-operative and postoperative opioid use is reported as morphine milligram | At the end of the surgery，24，48 and 72 hours after surgery | 
| Bowel function recovery | defined as the time to first defecation or time to first flatus | At 3 days after surgery | 
| Postoperative hospital stay | The days of hospital stay after the operation were calculated from the first day after the operation to the days of discharge. | up to 30 days | 
| Patient satisfaction scores | (satisfaction scores regarding pain control and the overall recovery process were obtained at 72 hours after surgery, using a 11-point Likert scale, with 0 indicating very dissatisfiedand10 indicating very satisfied | 72 hours after surgery |