The Study of Perioperative Intravenous Infusion of Lidocaine on Postoperative Analgesia in Patients Undergoing Single-port Thoracoscopic

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the effect of intravenous lidocaine infusion on pain and opioid dosage in patients undergoing single-port thoracoscopic surgery,and to evaluate the effects of perioperative catecholamine levels, extubation time, incidence of nausea and vomiting, patient satisfaction and hospital stay.

Detailed Description
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The World Congress on Pain identified pain as the fifth leading indicator of human life after breathing, pulse, body temperature and blood pressure. Postoperative pain is an acute nociceptive pain caused by surgical trauma and is a complex stress response in the body, especially in 72 hours after surgery. Pain after thoracic surgery is a more severe type of surgery in various types of surgery. Acute pain at the early stage of operation is not only an external signal of body injury, but also an independent factor inducing stress response and systemic inflammatory response syndrome (SIRS). Pain stimulus can also cause excessive release of catecholamine, damage of vascular endothelial cells and neutrophil aggregation, which can induce cytokine waterfall secretion. Stress, pain and inflammation induce and interact with each other, which seriously affects the early recovery of patients after operation. Timely and effective post-operative analgesia can not only alleviate patients'pain, but also avoid a series of stress reactions. It provides favorable conditions for the stability of patients' physiological function and recovery of their body after operation. Although multimodal analgesia has largely replaced monotherapy with opioids, they are still the most commonly used drugs for postoperative pain. Lidocaine is an amide local anesthetic which when used intravenously demonstrates significant analgesic, anti-hyperalgesic and anti-inflammatory properties . Intravenous infusion of lidocaine has a good effect on fibromyalgia, chronic neuropathic pain, opioid tolerance and other chronic pain, and can reduce postoperative acute pain. In the 1960s, Barlett et al. first published a study on the use of lidocaine intravenous infusion for postoperative analgesia.Since then, more and more researchers have begun to explore the use of lidocaine in the treatment of postoperative acute pain.In 2007, Kaba et al. selected patients who underwent colectomy as an experimental subject, and intravenously injected lidocaine during the perioperative period. The results showed that the pain of the experimental group was effectively relieved and the use of opioids was reduced. In 2008, Lauwick et al. used laparoscopic cholecystectomy as the experimental subject. The results showed that the dose of opioid analgesia in the lidocaine group was significantly lower than that in the control group, and the postoperative pain was effectively improved. In 2009, Yardeni et al. selected patients undergoing total hysterectomy as experimental subjects and intravenously injected lidocaine during the perioperative period. The results confirmed that the hemodynamics of the experimental group was more stable, the average dosage of anesthetics was reduced, and the pain was significantly improved.However, to date, there is no strong evidence for the effect of perioperative intravenous infusion of lidocaine in single-port thoracoscopic surgery, so we designed this study.

Official Title
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The Study of Perioperative Intravenous Infusion of Lidocaine on Postoperative Analgesia in Patients Undergoing Single-port Thoracoscopic

Conditions
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Surgery

Intervention / Treatment
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* Drug: Lidocaine
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing single-port thoracoscopic with a left double lumen bronchial catheter Age ≧ 18 years old, ≦70 years old Temperature, white blood cells, and hemoglobin were normal before surgery Patient informed consent Exclusion Criteria: Patients with a history of surgery within six months Patients with dysfunction of heart, liver, kidney, lung, pancreas or other important organs American Society of Anesthesiologists (ASA) physical Status classes ≧ Ⅲ Allergic to lidocaine Bradycardia (heart rate < 60 beats/min) or atrioventricular block Mental disorder Patients requiring a right double lumen bronchial catheter

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
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lidocaine group<br>First group (lidocaine group) will include those who receive a intraoperative lidocaine infusion.Induction bolus dose of 1.5 mg/kg body weight ( 30 minutes before incision)followed by a continous lidocaine infusion of 2mg/kg/h，until 1 hours after skin closure. | Drug: Lidocaine<br>* regimen of lidocaine administration of 1.5 mg/kg, IV bolus, followed by continuous infusion at 2 mg/kg/h<br>|
| Placebo Comparator: Saline group<br>The second group（saline group） will include those who receive a intraoperative placebo.The same dosage of saline was given according to the same method of administration in the lidocaine group. | Drug: Saline<br>* IV bolus of saline, followed by continuous infusion of saline<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain score | Using Visual Analogue Scales | Immediately postoperation | 
| Postoperative pain score | Using Visual Analogue Scales | 1 hour postoperation | 
| Postoperative pain score | Using Visual Analogue Scales | 4 hours postoperation | 
| Postoperative pain score | Using Visual Analogue Scales | 8 hours postoperation | 
| Postoperative pain score | Using Visual Analogue Scales | 24 hours postoperation | 
| Postoperative pain score | Using Visual Analogue Scales | 48 hours postoperation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid requirement | The dosage of opioids was recorded | Immediately postoperation | 
| Opioid requirement | The dosage of opioids was recorded | 1 hour postoperation | 
| Opioid requirement | The dosage of opioids was recorded | 4 hours postoperation | 
| Opioid requirement | The dosage of opioids was recorded | 8 hours postoperation | 
| Opioid requirement | The dosage of opioids was recorded | 24 hours postoperation | 
| Opioid requirement | The dosage of opioids was recorded | 48 hours postoperation | 
| Pressing times of PCIA postoperation | The pressing times of PCIA within 48 hours postoperation was recorded | 48 hours postoperation | 
| Occurrence of nausea and/or vomiting | The occurrence of nausea and vomiting within 48 hours postoperation was recorded | 48 hours postoperation | 
| Blood level of adrenaline | Perioperative blood level of adrenaline was recorded | before induction | 
| Blood level of adrenaline | Perioperative blood level of adrenaline was recorded | after incision | 
| Blood level of adrenaline | Perioperative blood level of adrenaline was recorded | immediately after extubation | 
| Blood level of norepinephrine | Perioperative blood level of norepinephrine was recorded | before induction | 
| Blood level of norepinephrine | Perioperative blood level of norepinephrine was recorded | after incision | 
| Blood level of norepinephrine | Perioperative blood level of norepinephrine was recorded | immediately after extubation | 
| Blood level of adrenocortical | Perioperative blood level of adrenocortical was recorded | before induction | 
| Blood level of adrenocortical | Perioperative blood level of adrenocortical was recorded | after incision | 
| Blood level of adrenocortical | Perioperative blood level of adrenocortical was recorded | immediately after extubation | 
| Blood level of TNF-alpha | Perioperative blood level of TNF-alpha was recorded | before induction | 
| Blood level of TNF-alpha | Perioperative blood level of TNF-alpha was recorded | after incision | 
| Blood level of TNF-alpha | Perioperative blood level of TNF-alpha was recorded | immediately after extubation | 
| Blood level of IL-6 | Perioperative blood level of IL-6 was recorded | before induction | 
| Blood level of IL-6 | Perioperative blood level of IL-6 was recorded | after incision | 
| Blood level of IL-6 | Perioperative blood level of IL-6 was recorded | immediately after extubation | 
| Blood level of IL-10 | Perioperative blood level of IL-10 was recorded | before induction | 
| Blood level of IL-10 | Perioperative blood level of IL-10 was recorded | after incision | 
| Blood level of IL-10 | Perioperative blood level of IL-10 was recorded | immediately after extubation | 
| Duration of hospital stay | length of hospital stay (in days) | from day of surgery until day of discharge from hospital | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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single-port thoracoscopic surgery, lidocaine, postoperative pain, opioid