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Clinical Trials/NCT04043624
NCT04043624
Unknown
Phase 4

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

Second Affiliated Hospital, School of Medicine, Zhejiang University1 site in 1 country80 target enrollmentAugust 1, 2019
ConditionsSurgery
InterventionsLidocaineSaline

Overview

Phase
Phase 4
Intervention
Lidocaine
Conditions
Surgery
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Enrollment
80
Locations
1
Primary Endpoint
Postoperative pain score
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 1, 2019
End Date
December 31, 2020
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Responsible Party
Sponsor

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

Arms & Interventions

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.

Intervention: Lidocaine

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.

Intervention: Saline

Outcomes

Primary Outcomes

Postoperative pain score

Time Frame: 48 hours postoperation

Using Visual Analogue Scales

Secondary Outcomes

  • Occurrence of nausea and/or vomiting(48 hours postoperation)
  • Blood level of adrenaline(immediately after extubation)
  • Blood level of norepinephrine(immediately after extubation)
  • Blood level of adrenocortical(immediately after extubation)
  • Blood level of TNF-alpha(immediately after extubation)
  • Blood level of IL-6(immediately after extubation)
  • Blood level of IL-10(immediately after extubation)
  • Duration of hospital stay(from day of surgery until day of discharge from hospital)
  • Pressing times of PCIA postoperation(48 hours postoperation)
  • Opioid requirement(48 hours postoperation)

Study Sites (1)

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