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Assessment the effect of lidocaine intravenous infusion on postoperative pain in patients with laparoscopic cholecystectomy under general anesthesia

Protocol summary

Study aim
Determining the effect of intravenous lidocaine infusion on pain after laparoscopic cholecystectomy under general anesthesia
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 2 on 80 patients. Blanced Block Randomization was used for randomization.
Settings and conduct
Background is determining the effect of lidocaine on pain after cholecystectomy. Velayat hospita in Qazvin, Iran. Researcher, patient, surgeon, nurse, and data analyzer were blinded to the type of group the patient was in. 80 patients for laparoscopic cholecystectomy were divided into two groups of control and intervention by random allocation.
Participants/Inclusion and exclusion criteria
Inclusion criteria include 18-50 years old, ASA class I-II patients, candidates for elective laparoscopic cholecystectomy. Exclusion criteria include a history of seizures, allergies, hypertension, cardiovascular disease, the need for blood transfusions or their products, and the duration of surgery is more than 2.5 hours.
Intervention groups
For all patients for premedication midazolam 0.02 mg / kg and fentanyl 1.5 micrograms / kg and for induction of anesthesia propofol at a dose of 2 mg / kg injection and maintenance by intravenous infusion of propofol 100 micro / kg / min with oxygen 100 Percentage will be done. In the intervention group, after induction of general anesthesia at the beginning of surgery, intravenous infusion of lidocaine for 10 minutes at a dose of 1.5 mg / kg, and also during surgery until the end of intravenous infusion of lidocaine at a dose of 1.5 mg / min It will be done for all patients. In the control group, instead of lidocaine, intravenous infusion of normal saline will be 0.9%.
Main outcome variables
Post operational pain

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20201214049720N1
Registration date: 2021-01-08, 1399/10/19
Registration timing: retrospective

Last update: 2021-01-08, 1399/10/19
Update count: 0
Registration date
2021-01-08, 1399/10/19
Registrant information
Name
Minoo Sami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3333 3333
Email address
drmsami709@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-23, 1398/07/01
Expected recruitment end date
2019-12-22, 1398/10/01
Actual recruitment start date
2019-09-23, 1398/07/01
Actual recruitment end date
2020-02-20, 1398/12/01
Trial completion date
2020-02-29, 1398/12/10
Scientific title
Assessment the effect of lidocaine intravenous infusion on postoperative pain in patients with laparoscopic cholecystectomy under general anesthesia
Public title
The effect of lidocaine on pain after gallbladder resection
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age range 18-150 years ASA class I-II patients Candidate for elective laparoscopic cholecystectomy
Exclusion criteria:
History of seizures Allergies Hypertension Cardiovascular disease Need for blood transfusion or its products Duration of surgery more than 2.5 hours
Age
From 18 years old to 50 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 40
Actual sample size reached: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the patient will not be aware of the type of study group in which he is placed, as well as the researcher, patient surgeon, patient care nurse in the operating room, recovery ward and post-surgery ward, as well as data analyzer will not be informed about patient grouping .
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Qazvin University of Medical Sciences
Street address
Qazvin University of Medical Sciences, Bahonar Blvd, Qazvin, Iran
City
Qazvin
Province
Qazvin
Postal code
3419759811
Approval date
2019-09-17, 1398/06/26
Ethics committee reference number
IR.QUMS.REC.1398.131

Health conditions studied

1

Description of health condition studied
cholecystitis
ICD-10 code
K80.01
ICD-10 code description
Calculus of gallbladder with acute cholecystitis with obstruction

Primary outcomes

1

Description
Post operational Pain
Timepoint
2, 4, 6 and 8 hours after surgery
Method of measurement
VAS

Secondary outcomes

1

Description
Amount of narcotic drug consumption
Timepoint
Post operation
Method of measurement
Patient Document

Intervention groups

1

Description
Intervention group: In the intervention group, after induction of general anesthesia at the beginning of surgery, intravenous infusion of lidocaine for 10 minutes at a dose of 1.5 mg / kg, and also during surgery until the end of intravenous infusion of lidocaine at a dose of 1.5 mg / min It will be done for all patients.
Category
Treatment - Drugs

2

Description
Control group: In the control group, instead of lidocaine, intravenous infusion of normal saline will be 0.9%.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Velayat Educational Hospital - Qazvin University of Medical Sciences
Full name of responsible person
Dr. Minoo Sami
Street address
Velayat Educational Hospital, Qazvin, Iran
City
Qazvin
Province
Qazvin
Postal code
3419759811
Phone
+98 28 3379 0620
Email
Ali32024@yahoo.com
Web page address
http://hosvelayat.qums.ac.ir/portal/home

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr. Hesein Moeini
Street address
Qazvin University of Medical Sciences, Bahonar Blvd, Qazvin, Iran.
City
Qazvin
Province
Qazvin
Postal code
3419759811
Phone
+98 28 3336 9001
Email
Info@qums.ac.ir
Web page address
http://www.qums.ac.ir/Portal/Home
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin University of Medical Sciences
Proportion provided by this source
5
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Minoo Sami
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
University of Medical Sciences, Bahonar Blvd, Qazvin, Iran.
City
Qazvin
Province
Qazvin
Postal code
3419759811
Phone
+98 28 3333 3333
Fax
Email
drmsami709@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr. Hesein Moeini
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Qazvin University of Medical Sciences, Bahonar Blvd, Qazvin, Iran.
City
Qazvin
Province
Qazvin
Postal code
3419759811
Phone
+98 28 3336 9001
Email
moeini200@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Minoo Sami
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
University of Medical Sciences, Bahonar Blvd, Qazvin, Iran.
City
Qazvin
Province
Qazvin
Postal code
3419759811
Phone
+98 28 3333 3333
Fax
Email
drmsami709@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Data on primary and secondary outcomes can be published.
When the data will become available and for how long
One year after the results are published
To whom data/document is available
Researchers and industry owners
Under which criteria data/document could be used
Use the results for further planning and research
From where data/document is obtainable
drmsami709@gmail.com
What processes are involved for a request to access data/document
drmsami709@gmail.com
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