Protocol summary

Study aim
Comparing the effects of lidocaine femoral block with lidocaine and ketamine with lidocaine and dexamethasone on pain reduction after hip fracture surgery. Using the results of the study in order to use a more appropriate drug in femoral block, reducing postoperative pain in patients, reducing the use of narcotic drugs to reduce postoperative pain.
Design
Clinical trial with a control group, with parallel groups, double-blind, randomized, phase 3 on 60 patients. Computer generated random numbers were used for randomization.
Settings and conduct
In the operating rooms of Ahvaz Golestan Hospital, after hip fracture surgery, patients are divided into 3 groups before transfer to recovery and femoral block is performed for them.
Participants/Inclusion and exclusion criteria
Entry requirements: All people who have undergone hip fracture surgery and are between 18 and 75 years old; Conditions of non-entry: people with history of seizures, history of drug allergy, history of coagulation disorders, drug addiction
Intervention groups
After the end of the surgery and before the patient is transferred to the recovery room, he is placed under femoral block. The first group receives lidocaine and ketamine intravenously, the second group receives lidocaine and dexamethasone intravenously, and the third group or the control group only receives lidocaine intravenously.
Main outcome variables
Pain level based on VAS criteria, pain-free duration after surgery

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20231113060039N1
Registration date: 2023-12-30, 1402/10/09
Registration timing: prospective

Last update: 2023-12-30, 1402/10/09
Update count: 0
Registration date
2023-12-30, 1402/10/09
Registrant information
Name
Mohammadreza Mozafari oregani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3391 3456
Email address
mozafari.mr@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-11, 1402/10/21
Expected recruitment end date
2024-02-11, 1402/11/22
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of femoral blockade of lidocaine and ketamine with lidocaine and dexamethasone on pain relief after femoral fracture surgery
Public title
" Effect of lidocaine and ketamine on pain relief after femoral fracture surgery" ؛ " Effect of lidocaine and dexamethasone on pain relief after femoral fracture surgery"
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
All people who have undergone femoral fracture surgery
Exclusion criteria:
People under 18 years old People over 75 years old People who have a history of drug allergy People who have addictions
Age
From 18 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
The randomly entered patients will be divided into 3 groups with a ratio of 1:1:1 using a table of random numbers generated by the computer. The distribution results will be sealed in an envelope and kept by the research director. On the day of the operation, the main researcher will hand over the envelope to the anesthesia assistant to prepare the test liquid (blocking drug). In fact, the patients and the anesthesia assistant will be blinded to the nature of the type of anesthetic.
Blinding (investigator's opinion)
Double blinded
Blinding description
The randomly entered patients will be divided into 3 groups with a ratio of 1:1:1 using a table of random numbers generated by the computer. The distribution results will be sealed in an envelope and kept by the research director. On the day of the operation, the main researcher will hand over the envelope to the anesthesia assistant to prepare the test liquid (blocking drug). In fact, the patients and the anesthesia assistant will be blinded to the nature of the type of anesthetic.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Golestan Hospital, Ahvaz Jundishapur University of Medical Sciences
Street address
Golestan, Farvardin Street, Golestan Hospital
City
Ahvaz
Province
Khouzestan
Postal code
6155965138
Approval date
2023-06-20, 1402/03/30
Ethics committee reference number
IR.AJUMS.HGOLESTAN.REC.1402.056

Health conditions studied

1

Description of health condition studied
Comparison of the pain level of patients after hip fracture surgery
ICD-10 code
G89.18
ICD-10 code description
Other acute postprocedural pain

Primary outcomes

1

Description
The amount of pain
Timepoint
0 minutes after the operation, 15 minutes after the operation, 30 minutes after the operation, 1 hour after the operation, 2 hours after the operation, 3 hours after the operation, 6 hours after the operation, 9 hours after the operation, 12 hours after Operation, 24 hours after the operation
Method of measurement
Visual Analogue Scale

Secondary outcomes

empty

Intervention groups

1

Description
First intervention group: lidocaine 1% (4mg/kg) and ketamine (50mg) are injected intravenously after the operation.
Category
Treatment - Other

2

Description
The second intervention group: lidocaine 1% (4mg/kg) and dexamethasone (8mg) are injected intravenously after the operation.
Category
Treatment - Other

3

Description
Control group: Lidocaine 1% (4mg/kg) is injected intravenously after the operation
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Operating rooms of Golestan Hospital, Ahvaz
Full name of responsible person
Mozafari Oregani, Mohammadreza
Street address
No.57, 2nd Gharbi St , kianpars, Ahvaz Town
City
Ahvaz
Province
Khouzestan
Postal code
6155811856
Phone
+98 61 3391 3456
Email
syadthsyn0@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Vaziri,Mahshid
Street address
Schoole of Medicine, Shahid Sadoughi University of Medical Sciences, Yazd, Iran
City
Yazd
Province
Yazd
Postal code
۸۹۱۵۱۷۳۱۶۰
Phone
+98 61 3311 4145
Email
syadthsyn0@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Mozafari oregani, Mohammadreza
Position
Intern
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
No57 , Phase1 , 2nd Gharbi St , Kianpars , Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6155811856
Phone
+98 61 3391 3456
Email
syadthsyn0@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammadreza Mozafari oregani
Position
Medical Intern
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
No.57 , West 2nd street , Kianpars
City
Ahvaz
Province
Khouzestan
Postal code
6155811856
Phone
+98 61 3391 3456
Fax
Email
mozafari.mr@ajums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammadreza Mozafari oregani
Position
Medical Intern
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
No.57 , West 2nd street , Kianpars
City
Ahvaz
Province
Khouzestan
Postal code
6155811856
Phone
+98 61 3391 3456
Fax
Email
mozafari.mr@ajums.ac.ir

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
There is no further information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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