Determining and comparing the preventive effect of lidocaine and ketamine on pain after upper limb orthopedic surgery
Design
A randomized, triple-blinding clinical trial, with parallel groups, Phase 3 on 180 patients
Settings and conduct
In this three-blind randomized clinical trial study, 180 eligible patients referred to Al-Zahra and Kashani Hospital in Isfahan will be included in the study and will be randomly divided into three groups. At the end of the surgery, patients are injected with lidocaine or ketamine or normal saline. Then the bleeding rate, hemodynamic parameters, and complications after surgery will be evaluated and compared between the two groups.
Participants/Inclusion and exclusion criteria
The inclusion criteria include patients who are candidates for elective upper extremity orthopedic surgery under general anesthesia, aged 65-18 years, and have informed consent to participate in this study.
Exclusion criteria include addiction to opioid products, having an underlying disease (hypertension and uncontrolled diabetes or any neurological disorder) that has led to impaired sensation or movement of the operated organ, and sensitivity to lidocaine or ketamine.
Intervention groups
The first intervention group: patients in this group will be injected with lidocaine infusion at a low dose (1 mg/kg/hour) at the end of the operation.
The second intervention group: patients in this group, at the end of the operation, are given intravenous ketamine infusion at a dose (0.25 mg per kilogram of body).
Control group: patients in this group will be injected with normal saline infusion.
Main outcome variables
Pain; Mean arterial pressure; Heart beat; Oxygen saturation (SPO2)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200825048515N68
Registration date:2023-06-14, 1402/03/24
Registration timing:prospective
Last update:2023-06-14, 1402/03/24
Update count:0
Registration date
2023-06-14, 1402/03/24
Registrant information
Name
Asieh Maghami Mehr
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 0000 0000
Email address
asimaghami@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-21, 1402/04/30
Expected recruitment end date
2024-03-19, 1402/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the preventive effect of lidocaine infusion and ketamine infusion on pain after upper limb orthopedic surgery under general anesthesia
Public title
The effect of lidocaine and ketamine on pain after upper limb orthopedic surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Candidate patients for elective upper extremity orthopedic surgery under general anesthesia
Age 65-18 years
Informed consent to participate in this study
Exclusion criteria:
Addiction to opioid products
Having an underlying disease (hypertension and uncontrolled diabetes or any neurological disorder) that has led to impaired sensation or movement of the operated organ
Hypersensitivity to lidocaine or ketamine
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
180
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, 180 eligible patients are randomly selected. Then the letters A, B and C are written on 60 sheets and each one is placed in an envelope. Each patient is then asked to choose one of the envelopes. Depending on the selected envelope, the patient is assigned to one of three groups.
Blinding (investigator's opinion)
Triple blinded
Blinding description
In order to achieve the triple-blind study, two drugs lidocaine and ketamine as well as placebo will be prepared daily by the operating room nurse (without the knowledge of the researcher) in the same syringes and labeled as A, B, C, and D. And is given daily to the anesthesiologist (researcher). Therefore, the patient, the Investigator, the person recording the clinical and basic information of the patients as well as the statistical analyst will not be aware of the type of intervention.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Hezar Jarib Ave, Azadi Square.
City
Isfaha
Province
Isfehan
Postal code
8174673461
Approval date
2022-10-26, 1401/08/04
Ethics committee reference number
IR.MUI.MED.REC.1401.275
Health conditions studied
1
Description of health condition studied
Upper extremity orthopedic surgery
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Mean arterial pressure
Timepoint
In the basic times, the first hour every 15 minutes, the second hour every 30 minutes, the next 4 hours every 1 hour and after that every 2 hours for 24 hours.
Method of measurement
Monitoring device
2
Description
Heart beat
Timepoint
In the basic times, the first hour every 15 minutes, the second hour every 30 minutes, the next 4 hours every 1 hour and after that every 2 hours for 24 hours.
Method of measurement
Monitoring device
3
Description
Oxygen saturation percentage (SPO2)
Timepoint
In the basic times, the first hour every 15 minutes, the second hour every 30 minutes, the next 4 hours every 1 hour and after that every 2 hours for 24 hours.
Method of measurement
Monitoring device
4
Description
Pain
Timepoint
In the basic times, the first hour every 15 minutes, the second hour every 30 minutes, the next 4 hours every 1 hour and after that every 2 hours for 24 hours.
Method of measurement
Visual Analogue Scale (VAS)
Secondary outcomes
empty
Intervention groups
1
Description
First intervention group: patients in this group will be injected with lidocaine infusion at a low dose (1 mg/kg/hour) at the end of the operation.
Category
Treatment - Drugs
2
Description
Second intervention group: patients in this group, at the end of the operation, are given intravenous ketamine infusion at a dose (0.25 mg per kilogram of body).
Category
Treatment - Drugs
3
Description
Control group: patients in this group will be injected with normal saline infusion.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra Hospital
Full name of responsible person
Alireza Hoghooghi
Street address
Soffe Blvd, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
alireza.hoghooghy@gmail.com
2
Recruitment center
Name of recruitment center
Kashani Hospital
Full name of responsible person
Alireza Hoghooghi
Street address
Kashani street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8183983434
Phone
+98 31 3233 0091
Email
alireza.hoghooghy@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholamreza Askari
Street address
Vice Chancellor for Research, Isfahan University of Medical Sciences and Health Services, Hezar Jarib Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8597
Email
dean@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Isfahan University of Medical Sciences
Proportion provided by this source
100
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
Esfahan University of Medical Sciences
Full name of responsible person
Alireza Hoghooghi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology Department, Al-Zahra Hospita, Sefeh Blvd., Tohid Street
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
alireza.hoghooghy@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Alireza Hoghooghi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology Department, Al-Zahra Hospita, Sefeh Blvd., Tohid Street
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
alireza.hoghooghy@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Marzieh Mahdi Zadeh
Position
Non-faculty specialist doctor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology Department, Al-Zahra Hospita, Sefeh Blvd., Tohid Street
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Fax
Email
marmi.mhd۱۳۷۶@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD