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Intravenous Lidocaine for Perioperative and Postoperative Analgesia

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ClinicalTrials.gov Identifier: NCT03921567
Recruitment Status : Recruiting
First Posted : April 19, 2019
Last Update Posted : April 22, 2019
Sponsor:
Information provided by (Responsible Party):
Rajmonda Nallbani-Komoni, University Clinical Centre of Kosova

Brief Summary:

Postoperative pain continues to be untreated despite the application of multimodal analgesia, medication and new analgesic techniques. Traditional opioid pain treatment has many side effects, while invasive methods, such as epidural catheter, have high costs and difficulties during application.

Lidocaine is a local anesthetic and its administration with intravenous routes has analgesic, antihyperalgic and antiinflammatory action. It increases the motility of the intestine and has antiemetic properties. The advantage of this method is the low cost of the preparation and its easy application. The intravenous administration of lidocaine for postoperative analgesia is recently used and not sufficiently researched technique .


Condition or disease Intervention/treatment Phase
Analgesic Drug Dependence Drug: Lidocaine Hydrochloride Drug: Lidocaine Hydrochloride and Ketamine Drug: Placebo Phase 4

Detailed Description:

The purpose of this research is to investigate the analgesic effects of intravenous lidocaine in the perioperative and postoperative period, on various surgical interventions. In the perioperative period, its effect on the reduction of opiodic use will be evaluated, while during the postoperative period will be evaluate the degree of analgesia, the rate of reduction of additional analgesics, the impact on the clinical parameters and the patient's rehabilitation.

The research will be conducted at the Clinic of Gynecology and Obstetrics, the Surgery Clinic, the Urology Clinic, the Orthopedic Clinic, of Universitary Clinical Centre of Kosovo and the American Hospital in Pristina, Republic of Kosovo.

The study will be conducted during the period April 2018 - January 2020.

After obtaining a permit from the ethics committee, all patients to be investigated will be informed first through the information form for all the risks and advantages of this analgesic technique and from them will be consented to their participation in the research.

In the intervention group of the study will be included 520 patients of both genders and ages 18-65 years. Patients will undergo these surgical interventions: gynecological, abdominal, laparoscopical, urological and orthopedic interventions.

The intervention group includes two groups for each type of surgery:

Group I (n = 50); at induction of anesthesia will be given lidocaine 2mg / kg / i.v., bolus, and in perioperative and postoperative period will be given lidocaine 1.5mg / kg / h-1, continuously during surgery and 48 hours after surgery.

Group II (n = 50); at induction of anesthesia will be given lidocaine 2mg / kg / i.v., bolus, and ketamine 0.15mg / kg / , bolus, i.v .; lidocaine will continue during the operation and in the postoperative period with a dose of 1.5mg / kg / h-1, continuously, during the operation and 48 hours after the operation.

The control group (n = 30) will be given opioids during surgery, and opioids and nonsteroid antiinflammatory agents will be given 48 hours after surgery.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 520 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Intravenous Lidocaine for Perioperative and Postoperative Analgesia
Actual Study Start Date : April 15, 2019
Estimated Primary Completion Date : October 30, 2019
Estimated Study Completion Date : January 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group I
at induction of anesthesia will be given lidocaine 2mg / kg / i.v., bolus, and in perioperative and postoperative period will be given lidocaine 1.5mg / kg / h-1, continuously during surgery and 48 hours after surgery.
Drug: Lidocaine Hydrochloride
at induction of anesthesia will be given lidocaine 2mg / kg / i.v., bolus, and in perioperative and postoperative period will be given lidocaine 1.5mg / kg / h-1, continuously during surgery and 48 hours after surgery.
Other Name: Lidocaine Hydrochloride ampule

Active Comparator: Group II
at induction of anesthesia will be given lidocaine 2mg / kg / i.v., bolus, and ketamine 0.15mg / kg / , bolus, i.v .; lidocaine will continue during the operation and in the postoperative period with a dose of 1.5mg / kg / h-1, continuously, during the operation and 48 hours after the operation
Drug: Lidocaine Hydrochloride
at induction of anesthesia will be given lidocaine 2mg / kg / i.v., bolus, and in perioperative and postoperative period will be given lidocaine 1.5mg / kg / h-1, continuously during surgery and 48 hours after surgery.
Other Name: Lidocaine Hydrochloride ampule

Drug: Lidocaine Hydrochloride and Ketamine
at induction of anesthesia will be given lidocaine 2mg / kg / i.v., bolus, and ketamine 0.15mg / kg / , bolus, i.v .; lidocaine will continue during the operation and in the postoperative period with a dose of 1.5mg / kg / h-1, continuously, during the operation and 48 hours after the operation
Other Name: Lidocaine Hydrochloride ampule and Ketamine ampule

Placebo Comparator: The control group
will be given opioids during surgery, opioids and nonsteroid antiinflammatory agents will be given 48 hours after surgery.
Drug: Placebo
will be given opioids during surgery, and opioids and nonsteroid antiinflammatory agents will be given 48 hours after surgery.
Other Name: Placebo for(lidocaine hydrochloride)




Primary Outcome Measures :
  1. Reduction of opiods used during perioperative period and other analgesics used during postoperative period [ Time Frame: 48 hours after surgical intervention ]

    The primary outcome measures are: the use of opiods and other analgesics during and 48 hours after the surgical intervention.

    During the intraoperative period, it will be investigated how the application of intravenous lidocaine will reduce the amount of opiodes used, amd during the postoperative period will be investigated when the application of other analgesics will start and which analgesics will be used as well,how often they will be given and in which dose.

    The analgesics which will be investigated include routine analgesics found in our hospital:

    • tramadol
    • acetaminophen
    • diclophenac
    • ketorolac
    • others


Secondary Outcome Measures :
  1. Pain scores measured at rest and during the movement with Visual Analog Scale [ Time Frame: 48 hours after surgical intervention ]
    • Pain scores measured at rest and during the movement with Visual Analog Scale
    • the beginning of the intestinal motility,
    • side effects (nausea, vomiting, headache, hypotension, arrhythmias, dizziness ,hallucinations etc)

    Postoperative analgesia will be determined through the VAS scale-Visual Analog Scale. This scale will be used to determinate the intensity of pain in patients in the postoperative period, initially determining the intensity of pain in silence as well as after mobilization or motion, i.e Visual Dynamic Scale.

    This scale determines the intensity of the pain and is expressed in a numeric value from1-10. 0- no pain, 1-2- mild pain, 3-6 moderate pain, 7-10 severe pain.




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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age of both genders from 18 to 75 years
  • ASA physiological status I-III
  • Participation in abdominal, orthopedic, laparoscopical, gynecological and urological interventions.

Exclusion Criteria:

  • Patient rejection
  • History of chronic opioid intake
  • History of renal, hepatic or psychiatric disorders
  • Heart failure,
  • Organ transplant history,
  • Lidocaine allergy
  • Family history of malignant hyperthermia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03921567


Contacts
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Contact: Rajmonda Nallbani +38344188872 rajmonda.nallbani@uni-pr.edu
Contact: Antigona Hasani +38344402781 ext 44402781 antigona.hasani@uni-pr.edu

Locations
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Kosovo
University Clinical Centre of Kosovo Recruiting
Pristina, Kosovo, 10000
Contact    +38138512656    drejtoria.shskuk@rks.gov.net   
University of Pristina, Faculty of Medicine Recruiting
Pristina, Kosovo, 10000
Contact    +383-38-512221    mjekesia@uni-pr.edu   
Sponsors and Collaborators
Rajmonda Nallbani-Komoni
Investigators
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Study Director: Antigona Hasani, Profesor University of Pristina, Faculty of Medicine, 10000 Pristina, Kosovo

Publications of Results:

Other Publications:
1. Mendonça* FT, Reis MC, Aguiar JA and Calvano LA Systemic Lidocaine for Perioperative Analgesia: A Literature Review, J Anest & Inten Care Med. 2015;1(1): 555551.

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Responsible Party: Rajmonda Nallbani-Komoni, Principal investigator, University Clinical Centre of Kosova
ClinicalTrials.gov Identifier: NCT03921567     History of Changes
Other Study ID Numbers: UCCKosovo
First Posted: April 19, 2019    Key Record Dates
Last Update Posted: April 22, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data for primary and secondary outcome measures will be made available
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data will be available within 6 months of study completion
Access Criteria: Requestors will be required to sign a Data Access Agreement and then these requests will be reviewed by an Independent Review Panel.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Rajmonda Nallbani-Komoni, University Clinical Centre of Kosova:
Analgesia
Perioperative periode
Postoperative periode
VAS scale

Additional relevant MeSH terms:
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Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Anesthetics
Lidocaine
Ketamine
Anti-Inflammatory Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Analgesics
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents