Clinical trial NCT04043624: The Study of Perioperative Intravenous Infusion of Lidocaine on Postoperative Analgesia in Patients Undergoing Single-port Thoracoscopic
Official title: The Study of Perioperative Intravenous Infusion of Lidocaine on Postoperative Analgesia in Patients Undergoing Single-port Thoracoscopic
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Surgery
Keywords: single-port thoracoscopic surgery
lidocaine
postoperative pain
opioid
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2019-08-02
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Postoperative pain score
timeFrame: Immediately postoperation
measure: Postoperative pain score
timeFrame: 1 hour postoperation
measure: Postoperative pain score
timeFrame: 4 hours postoperation
measure: Postoperative pain score
timeFrame: 8 hours postoperation
measure: Postoperative pain score
timeFrame: 24 hours postoperation
measure: Postoperative pain score
timeFrame: 48 hours postoperation
Secondary outcomes:
measure: Opioid requirement
timeFrame: Immediately postoperation
measure: Opioid requirement
timeFrame: 1 hour postoperation
measure: Opioid requirement
timeFrame: 4 hours postoperation
measure: Opioid requirement
timeFrame: 8 hours postoperation
measure: Opioid requirement
timeFrame: 24 hours postoperation
measure: Opioid requirement
timeFrame: 48 hours postoperation
measure: Pressing times of PCIA postoperation
timeFrame: 48 hours postoperation
measure: Occurrence of nausea and/or vomiting
timeFrame: 48 hours postoperation
measure: Blood level of adrenaline
timeFrame: before induction
measure: Blood level of adrenaline
timeFrame: after incision
measure: Blood level of adrenaline
timeFrame: immediately after extubation
measure: Blood level of norepinephrine
timeFrame: before induction
measure: Blood level of norepinephrine
timeFrame: after incision
measure: Blood level of norepinephrine
timeFrame: immediately after extubation
measure: Blood level of adrenocortical
timeFrame: before induction
measure: Blood level of adrenocortical
timeFrame: after incision
measure: Blood level of adrenocortical
timeFrame: immediately after extubation
measure: Blood level of TNF-alpha
timeFrame: before induction
measure: Blood level of TNF-alpha
timeFrame: after incision
measure: Blood level of TNF-alpha
timeFrame: immediately after extubation
measure: Blood level of IL-6
timeFrame: before induction
measure: Blood level of IL-6
timeFrame: after incision
measure: Blood level of IL-6
timeFrame: immediately after extubation
measure: Blood level of IL-10
timeFrame: before induction
measure: Blood level of IL-10
timeFrame: after incision
measure: Blood level of IL-10
timeFrame: immediately after extubation
measure: Duration of hospital stay
timeFrame: from day of surgery until day of discharge from hospital
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The Second Affiliated Hospital Zhejiang University School of Medicine
state: Zhejiang
Study officials:
affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Congcong Chen
role: STUDY_CHAIR
References:
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):1050-1055. doi: 10.1213/01.ANE.0000104582.71710.EE.
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.
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;2005(4):CD003345. doi: 10.1002/14651858.CD003345.pub2.
citation: 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.
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.
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. doi: 10.1007/BF03016348.
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. doi: 10.1097/00000542-200701000-00007.
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.
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. doi: 10.1097/00000542-199207000-00011.
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