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

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.

Study Overview

• Status: Unknown
• Conditions: Surgery
• Intervention / Treatment: Drug: Lidocaine; Drug: Saline

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • Recruiting
      • The Second Affiliated Hospital Zhejiang University School of Medicine
      • Contact: Jin Ma; Phone Number: 86+18867539602; Email: 1241370980@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lidocaine group; 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; regimen of lidocaine administration of 1.5 mg/kg, IV bolus, followed by continuous infusion at 2 mg/kg/h
Placebo Comparator: Saline group; 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; IV bolus of saline, followed by continuous infusion of saline

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Investigators: Study Chair: Congcong Chen, Second Affiliated Hospital, School of Medicine, Zhejiang University

Publications and helpful links

General Publications

• Lauwick S, Kim DJ, Michelagnoli G, Mistraletti G, Feldman L, Fried G, Carli F. Intraoperative infusion of lidocaine reduces postoperative fentanyl requirements in patients undergoing laparoscopic cholecystectomy. Can J Anaesth. 2008 Nov;55(11):754-60. doi: 10.1007/BF03016348.
• Kaba A, Laurent SR, Detroz BJ, Sessler DI, Durieux ME, Lamy ML, Joris JL. Intravenous lidocaine infusion facilitates acute rehabilitation after laparoscopic colectomy. Anesthesiology. 2007 Jan;106(1):11-8; discussion 5-6. doi: 10.1097/00000542-200701000-00007.
• Koppert W, Weigand M, Neumann F, Sittl R, Schuettler J, Schmelz M, Hering W. Perioperative intravenous lidocaine has preventive effects on postoperative pain and morphine consumption after major abdominal surgery. Anesth Analg. 2004 Apr;98(4):1050-1055. doi: 10.1213/01.ANE.0000104582.71710.EE.
• Yardeni IZ, Beilin B, Mayburd E, Levinson Y, Bessler H. The effect of perioperative intravenous lidocaine on postoperative pain and immune function. Anesth Analg. 2009 Nov;109(5):1464-9. doi: 10.1213/ANE.0b013e3181bab1bd.
• Schafranski MD, Malucelli T, Machado F, Takeshi H, Kaiber F, Schmidt C, Harth F. Intravenous lidocaine for fibromyalgia syndrome: an open trial. Clin Rheumatol. 2009 Jul;28(7):853-5. doi: 10.1007/s10067-009-1137-8. Epub 2009 Mar 5.
• Challapalli V, Tremont-Lukats IW, McNicol ED, Lau J, Carr DB. Systemic administration of local anesthetic agents to relieve neuropathic pain. Cochrane Database Syst Rev. 2005 Oct 19;2005(4):CD003345. doi: 10.1002/14651858.CD003345.pub2.
• Buchanan DD, J MacIvor F. A role for intravenous lidocaine in severe cancer-related neuropathic pain at the end-of-life. Support Care Cancer. 2010 Jul;18(7):899-901. doi: 10.1007/s00520-010-0864-3. Epub 2010 Apr 29.
• Sharma S, Rajagopal MR, Palat G, Singh C, Haji AG, Jain D. A phase II pilot study to evaluate use of intravenous lidocaine for opioid-refractory pain in cancer patients. J Pain Symptom Manage. 2009 Jan;37(1):85-93. doi: 10.1016/j.jpainsymman.2007.12.023. Epub 2008 Jul 2.
• Eriksson AS, Sinclair R, Cassuto J, Thomsen P. Influence of lidocaine on leukocyte function in the surgical wound. Anesthesiology. 1992 Jul;77(1):74-8. doi: 10.1097/00000542-199207000-00011.
• Feng G, Liu S, Wang GL, Liu GJ. Lidocaine attenuates lipopolysaccharide-induced acute lung injury through inhibiting NF-kappaB activation. Pharmacology. 2008;81(1):32-40. doi: 10.1159/000107792. Epub 2007 Sep 4.

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2019
• Primary Completion (Anticipated): December 31, 2019
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: July 19, 2019
• First Submitted That Met QC Criteria: July 31, 2019
• First Posted (Actual): August 2, 2019

Study Record Updates

• Last Update Posted (Actual): August 2, 2019
• Last Update Submitted That Met QC Criteria: July 31, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: opioid; lidocaine; postoperative pain; single-port thoracoscopic surgery
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: 2019-084

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No