Efficacy of Intravenous Lidocaine on Postoperative Pain and Recovery in Patients Undergoing Hepatectomy

Study Overview
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Brief Summary
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Patients who meet the enrollment criteria will be randomized 1:1 to either the lidocaine or the placebo group. 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. In the placebo group, the same volume of normal saline will be administered during anesthesia.

Detailed Description
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Patients who meet the enrollment criteria will be randomized 1:1 to either the lidocaine or the placebo group. 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. Blood samples will be drawn immediately after the bolus infusion of lidocaine, at the end of the surgery, and 24 hours after surgery to measure plasma lidocaine concentrations. Blood samples will also be collected 24 hours after surgery for subsequent measurement of IL-6, and tumor necrosis factor-α (TNF-α). The obtained samples will be labeled, centrifuged, frozen, and stored locally at -80° for subsequent testing. 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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Efficacy of Prolonging Intravenous Lidocaine by 72 Hours on Postoperative Pain and Recovery in Patients Undergoing Hepatectomy: a Prospective Randomized Controlled Study

Conditions
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Primary Liver Cancer

Intervention / Treatment
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* Drug: Lidocaine Hydrochloride, Injectable
* Drug: 0.9% normal saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 18-80 years old American Society of Anesthesiologists(ASA) Ⅰ～III patients scheduled for elective hepatectomy Exclusion Criteria: • body weight < 40 kg or >100 kg; metastases occurring in other distant organs; severe hepatic insufficiency (aspartate aminotransferase or alanine transaminase or bilirubin > 2.5 times the upper limit of normal), renal impairment (creatinine clearance < 60 ml/min); cardiac rhythm disorders or systolic heart failure (second-and third-degree heart block, ejection fraction < 50%); with allergies to any of the trial drugs; inability to comprehend numeric rating scale.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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 group received lidocaine and the control group received the same amount of saline.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lidocaine group<br>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. | Drug: Lidocaine Hydrochloride, Injectable<br>* 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.<br>* Other names: lidocaine group;|
| Placebo Comparator: placebo group<br>the same volume of normal saline will be administered during anesthesia. | Drug: 0.9% normal saline<br>* 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.<br>* Other names: placebo group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome is the incidence of moderate to severe pain (NRS ≥ 4) during movement (i.e. deep breathing) at 24 hours after surgery. | 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 representing the strongest pain. | The first 24 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of moderate to severe pain at 24 hours after surgery at rest | 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 representing the strongest pain. | The first 24 hours after surgery | 
| The incidence of moderate to severe pain at 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 representing the strongest pain. | At 3 days after surgery | 
| The cumulative morphine consumption at 24, 48 and 72 hours postoperatively | intra-operative and postoperative opioid use is reported as morphine milligram equivalents, calculated using the Practical Pain Management calculator | 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 | 
| The incidence of PONV during the first 72 hours after surgery | we considered it PONV if patients felt any nausea or had any vomiting | At 3 days after surgery | 
| The incidence of a composite of postoperative pulmonary complications during hospitalization | defined as positive if any component developed before discharge after surgery; These complications included respiratory infection, respiratory failure, pleural effusion, atelectasis, pneumothorax, bronchospasm, or aspiration pneumonitis loading dose, immediately after the end of surgery, and at the first 24 hours after surgery | during the period from the end of surgery to discharge | 
| Length of hospital stay | determined by the number of days from admittance to discharge | during the period from the end of surgery to discharge | 
| 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 and before discharge | 
| Levels of inflammatory factors ( IL-6, TNF-α) at 24 hours after surgery. | Levels of inflammatory factors ( IL-6, TNF-α) at 24 hours after surgery. | at 24 hours after surgery. |