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

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04043624
Enrollment
80
Registered
2019-08-02
Start date
2019-08-01
Completion date
2020-12-31
Last updated
2019-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgery

Keywords

single-port thoracoscopic surgery, lidocaine, postoperative pain, opioid

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.

Interventions

DRUGLidocaine

regimen of lidocaine administration of 1.5 mg/kg, IV bolus, followed by continuous infusion at 2 mg/kg/h

DRUGSaline

IV bolus of saline, followed by continuous infusion of saline

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Postoperative pain scoreImmediately postoperationUsing Visual Analogue Scales

Secondary

MeasureTime frameDescription
Pressing times of PCIA postoperation48 hours postoperationThe pressing times of PCIA within 48 hours postoperation was recorded
Occurrence of nausea and/or vomiting48 hours postoperationThe occurrence of nausea and vomiting within 48 hours postoperation was recorded
Blood level of adrenalinebefore inductionPerioperative blood level of adrenaline was recorded
Blood level of norepinephrinebefore inductionPerioperative blood level of norepinephrine was recorded
Opioid requirementImmediately postoperationThe dosage of opioids was recorded
Blood level of TNF-alphabefore inductionPerioperative blood level of TNF-alpha was recorded
Blood level of IL-6before inductionPerioperative blood level of IL-6 was recorded
Blood level of IL-10before inductionPerioperative blood level of IL-10 was recorded
Duration of hospital stayfrom day of surgery until day of discharge from hospitallength of hospital stay (in days)
Blood level of adrenocorticalbefore inductionPerioperative blood level of adrenocortical was recorded

Countries

China

Contacts

Primary ContactJin Ma
1241370980@qq.com86+18867539602

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026