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

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04043624
• Other study ID #: 2019-084
• Status: Recruiting
• Phase: Phase 4
• Start date: August 1, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: July 2019
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Jin Ma
• Phone: 86+18867539602
• Email: 1241370980[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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 ? ?

• Allergic to lidocaine

• Bradycardia (heart rate < 60 beats/min) or atrioventricular block

• Mental disorder

• Patients requiring a right double lumen bronchial catheter

Related Conditions & MeSH terms

• Surgery

Intervention

Drug:
• Lidocaine
regimen of lidocaine administration of 1.5 mg/kg, IV bolus, followed by continuous infusion at 2 mg/kg/h
• Saline
IV bolus of saline, followed by continuous infusion of saline

Locations

Country	Name	City	State
China	The Second Affiliated Hospital Zhejiang University School of Medicine	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

References & Publications (10)

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. — View Citation

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;(4):CD003345. Review. — View Citation

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. — View Citation

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. Epub 2007 Sep 4. — View Citation

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. — View Citation

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):1050-5, table of contents. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

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