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

NCT04043624 | Unknown Phase 4 DMC

• 1 other identifier: 2019-084
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgery

Keywords

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

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (27)

• Opioid requirement

  Immediately postoperation

• Opioid requirement

  1 hour postoperation

• Opioid requirement

  4 hours postoperation

• Opioid requirement

  8 hours postoperation

• Opioid requirement

  24 hours postoperation

Study Arms (2)

Lidocaine group

EXPERIMENTAL

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

Saline group

PLACEBO COMPARATOR

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

Interventions

Lidocaine DRUG

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

Lidocaine group

Saline DRUG

IV bolus of saline, followed by continuous infusion of saline

Saline group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

RECRUITING

Related Publications (10)

• 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.

  PMID: 15041597 BACKGROUND

• 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.

  PMID: 19263182 BACKGROUND

• 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.

  PMID: 16235318 BACKGROUND

• 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.

  PMID: 20429016 BACKGROUND

• 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.

  PMID: 18599258 BACKGROUND

• 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.

  PMID: 19138915 BACKGROUND

• 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.

  PMID: 17197840 BACKGROUND

• 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.

  PMID: 19843784 BACKGROUND

• 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.

  PMID: 1610012 BACKGROUND

• 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.

  PMID: 17785997 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Lidocaine; Sodium Chloride

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Congcong Chen

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  STUDY CHAIR

Central Study Contacts

Jin Ma

CONTACT

86+18867539602; 1241370980@qq.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2019
• First Posted: August 2, 2019
• Study Start: August 1, 2019
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2020
• Last Updated: August 2, 2019

Record last verified: 2019-07

Locations

CN (1)