Studying the intravenous lidocaine infusion effect on pain in patients undergoing femoral neck fracture surgery
Design
A double-blind, randomized clinical trial study with parallel groups and phase 3 on 64 patients.Randomization will be done with the block randomization method using Random allocation software.
Settings and conduct
This study will be conducted on patients who are candidates for femoral neck fracture surgery referring to Urmia Imam Khomeini hospital. The study will be conducted as a double-blind clinical trial. The patient and the researcher evaluating the outcomes will be blind to the allocation of patients into intervention or placebo groups.
Participants/Inclusion and exclusion criteria
In this study, 64 patients undergoing femoral neck fracture surgery with age between 18 to 85 years will be included. Patients with a history of cardiovascular, liver, and kidney diseases, endocrine diseases, and users of opioids, analgesics and steroids will be excluded.
Intervention groups
First, all patients will receive intravenous midazolam (0.05 mg/kg) and intravenous fentanyl (2 μg/kg) as premedication. 5 minutes later, propofol 2 mg/kg and atracurium 0.5 mg/kg will be injected. 10 minutes before the surgery, in the intervention group; firstly, 1.5 mg/kg intravenously of lidocaine solution 1% will be injected; then the infusion of lidocaine 1% with a dose of 2 mg/kg per hour will be started with a syringe pump infusion device. in the placebo group; Firstly, 1.5 ml/kg of normal saline solution will be used intravenously and then 2 mg/kg per hour as an infusion.
Main outcome variables
pain intensity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170516033992N12
Registration date:2022-11-29, 1401/09/08
Registration timing:prospective
Last update:2022-11-29, 1401/09/08
Update count:0
Registration date
2022-11-29, 1401/09/08
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3222 2010
Email address
karami.t@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-22, 1401/10/01
Expected recruitment end date
2023-04-20, 1402/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Studying the intravenous lidocaine infusion effect on pain in patients undergoing femoral neck fracture surgery
Public title
Studying the intravenous lidocaine infusion effect on pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients undergoing femoral neck fracture surgery
Age between 18 to 85 years
Patients with physical status one and two according to the criteria of the American Anesthesia Association (ASA I, II)
Exclusion criteria:
History of allergy to local anesthetics
Use of opioids and analgesics
Use of steroids
Pregnancy
A history of heart failure
Having liver and kidney diseases
Uncontrolled blood pressure
Endocrine diseases
Body mass index (BMI) above 40 kg/m2
Age
From 18 years old to 85 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be divided into intervention or placebo groups using the block randomization method based on generated numbers by Random allocation software. Thus, in this software, first, the number of groups and the total determined sample size will be entered, and then in the block section, the Block randomization method will be implemented. According to the total sample size (64 patients), 16 blocks of 4 will be used. Patients will be allocated to intervention or placebo groups based on generated numbers.
Blinding (investigator's opinion)
Double blinded
Blinding description
The study will be conducted as a double-blind clinical trial. The patient and the researcher evaluating the outcomes will be blind to the allocation of patients into intervention or placebo groups. Syringes containing drug and placebo will be similar in shape and size and the drug will be prescribed by an anesthesiologist (other than the outcome assessor). so, the table of computer-generated numbers will be given to the anesthesiologist. The anesthesiologist will enter the patients into groups according to the order of numbers. Finally, the name of groups will be encoded with the letters A and B.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Urmia University of Medical Sciences
Street address
Urmia University of Medical Sciences, Resalat street, Jahad Blvd., Urmia, Iran.
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Approval date
2022-09-21, 1401/06/30
Ethics committee reference number
IR.UMSU.REC.1401.251
Health conditions studied
1
Description of health condition studied
Fracture of neck of femur
ICD-10 code
NC72.2
ICD-10 code description
Fracture of neck of femur
Primary outcomes
1
Description
Pain intensity
Timepoint
Recovery, 6, 12 and 24 hours after the intervention
Method of measurement
Visual Analog Scale (VAS )
Secondary outcomes
1
Description
Administration of fentanyl as analgesic
Timepoint
During 24 hours after the intervention
Method of measurement
no, yes
2
Description
Systolic blood pressure
Timepoint
Before, recovery, 6, 12 and 24 hours after the intervention
Method of measurement
monotring
3
Description
diastolic blood pressure
Timepoint
Before, recovery, 6, 12 and 24 hours after the intervention
Method of measurement
monotring
Intervention groups
1
Description
Intervention group: First, all patients will receive intravenous midazolam (0.05 mg/kg) and intravenous fentanyl (2 μg/kg) as premedication. 5 minutes later, propofol 2 mg/kg and atracurium 0.5 mg/kg will be injected. 10 minutes before the surgery, in the intervention group; firstly, 1.5 mg/kg intravenously of lidocaine solution 1% will be injected; then the infusion of lidocaine 1% with a dose of 2 mg/kg per hour will be started with a syringe pump infusion device.
Category
Treatment - Drugs
2
Description
Control group: First, all patients will receive intravenous midazolam (0.05 mg/kg) and intravenous fentanyl (2 μg/kg) as premedication. 5 minutes later, propofol 2 mg/kg and atracurium 0.5 mg/kg will be injected. 10 minutes before the surgery, 1.5 ml/kg of normal saline solution will be used intravenously and then 2 mg/kg per hour as an infusion.