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Intravenous Lidocaine for Perioperative and Postoperative Analgesia

Primary Purpose

Analgesic Drug Dependence

Status
Unknown status
Phase
Phase 4
Locations
Kosovo
Study Type
Interventional
Intervention
Lidocaine Hydrochloride
Lidocaine Hydrochloride and Ketamine
Placebo
Sponsored by
Rajmonda Nallbani-Komoni
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Analgesic Drug Dependence focused on measuring Analgesia, Perioperative periode, Postoperative periode, VAS scale

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University Clinical Centre of KosovoRecruiting
  • University of Pristina, Faculty of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Group I

Group II

The control group

Arm Description

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.

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

will be given opioids during surgery, opioids and nonsteroid antiinflammatory agents will be given 48 hours after surgery.

Outcomes

Primary Outcome Measures

Reduction of opiods used during perioperative period and other analgesics used during postoperative period
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

Pain scores measured at rest and during the movement with Visual Analog Scale
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.

Full Information

First Posted
April 16, 2019
Last Updated
April 18, 2019
Sponsor
Rajmonda Nallbani-Komoni
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1. Study Identification

Unique Protocol Identification Number
NCT03921567
Brief Title
Intravenous Lidocaine for Perioperative and Postoperative Analgesia
Official Title
Intravenous Lidocaine for Perioperative and Postoperative Analgesia
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 15, 2019 (Actual)
Primary Completion Date
October 30, 2019 (Anticipated)
Study Completion Date
January 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Rajmonda Nallbani-Komoni

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Analgesic Drug Dependence
Keywords
Analgesia, Perioperative periode, Postoperative periode, VAS scale

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
520 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group I
Arm Type
Experimental
Arm Description
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.
Arm Title
Group II
Arm Type
Active Comparator
Arm Description
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
Arm Title
The control group
Arm Type
Placebo Comparator
Arm Description
will be given opioids during surgery, opioids and nonsteroid antiinflammatory agents will be given 48 hours after surgery.
Intervention Type
Drug
Intervention Name(s)
Lidocaine Hydrochloride
Other Intervention Name(s)
Lidocaine Hydrochloride ampule
Intervention Description
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 Type
Drug
Intervention Name(s)
Lidocaine Hydrochloride and Ketamine
Other Intervention Name(s)
Lidocaine Hydrochloride ampule and Ketamine ampule
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo for(lidocaine hydrochloride)
Intervention Description
will be given opioids during surgery, and opioids and nonsteroid antiinflammatory agents will be given 48 hours after surgery.
Primary Outcome Measure Information:
Title
Reduction of opiods used during perioperative period and other analgesics used during postoperative period
Description
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
Time Frame
48 hours after surgical intervention
Secondary Outcome Measure Information:
Title
Pain scores measured at rest and during the movement with Visual Analog Scale
Description
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.
Time Frame
48 hours after surgical intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rajmonda Nallbani
Phone
+38344188872
Email
rajmonda.nallbani@uni-pr.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Antigona Hasani
Phone
+38344402781
Ext
44402781
Email
antigona.hasani@uni-pr.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antigona Hasani, Profesor
Organizational Affiliation
University of Pristina, Faculty of Medicine, 10000 Pristina, Kosovo
Official's Role
Study Director
Facility Information:
Facility Name
University Clinical Centre of Kosovo
City
Pristina
ZIP/Postal Code
10000
Country
Kosovo
Individual Site Status
Recruiting
Facility Contact:
Phone
+38138512656
Email
drejtoria.shskuk@rks.gov.net
Facility Name
University of Pristina, Faculty of Medicine
City
Pristina
ZIP/Postal Code
10000
Country
Kosovo
Individual Site Status
Recruiting
Facility Contact:
Phone
+383-38-512221
Email
mjekesia@uni-pr.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data for primary and secondary outcome measures will be made available
IPD Sharing Time Frame
Data will be available within 6 months of study completion
IPD Sharing Access Criteria
Requestors will be required to sign a Data Access Agreement and then these requests will be reviewed by an Independent Review Panel.
Citations:
Citation
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Intravenous Lidocaine for Perioperative and Postoperative Analgesia

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