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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

Tracking Information
First Submitted Date  ICMJE April 16, 2019
First Posted Date  ICMJE April 19, 2019
Last Update Posted Date April 22, 2019
Actual Study Start Date  ICMJE April 15, 2019
Estimated Primary Completion Date October 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 18, 2019)
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
Original Primary Outcome Measures  ICMJE
 (submitted: April 16, 2019)
The use of opiods and other analgesics [ Time Frame: 48 hours after surgical intervention ]
The primary outcome measures are: the use of opioids and other analgesics during and 48 hours after the surgical intervention.
Change History Complete list of historical versions of study NCT03921567 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 18, 2019)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 16, 2019)
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.).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intravenous Lidocaine for Perioperative and Postoperative Analgesia
Official Title  ICMJE Intravenous Lidocaine for Perioperative and Postoperative Analgesia
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 .

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Analgesic Drug Dependence
Intervention  ICMJE
  • 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
  • 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)
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Lidocaine Hydrochloride
  • 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
    Interventions:
    • Drug: Lidocaine Hydrochloride
    • Drug: Lidocaine Hydrochloride and Ketamine
  • Placebo Comparator: The control group
    will be given opioids during surgery, opioids and nonsteroid antiinflammatory agents will be given 48 hours after surgery.
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 16, 2019)
520
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 30, 2020
Estimated Primary Completion Date October 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Rajmonda Nallbani +38344188872 rajmonda.nallbani@uni-pr.edu
Contact: Antigona Hasani +38344402781 ext 44402781 antigona.hasani@uni-pr.edu
Listed Location Countries  ICMJE Kosovo
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03921567
Other Study ID Numbers  ICMJE UCCKosovo
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Individual participant data for primary and secondary outcome measures will be made available
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: 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.
Responsible Party Rajmonda Nallbani-Komoni, University Clinical Centre of Kosova
Study Sponsor  ICMJE Rajmonda Nallbani-Komoni
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Antigona Hasani, Profesor University of Pristina, Faculty of Medicine, 10000 Pristina, Kosovo
PRS Account University Clinical Centre of Kosova
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP