Investigating the effect of using dexmedetomidine in fascia iliaca block on postoperative analgesia in patients undergoing femoral fractures surgery
Design
Clinical trial with double-blinded parallel groups randomized using Random Allocation Software (RAS) (in 20 blocks of 4)
Settings and conduct
In this double-blind study, patients between the ages of 25 and 75 years who are candidates for femoral fracture surgery under spinal anesthesia in Urmia Imam Khomeini Hospital will be included. the patients and the researcher will be blinded about the intervention or control groups.
Participants/Inclusion and exclusion criteria
In current study, 75 patients with femoral fracture surgery under spinal anesthesia , American Society of Anesthesiologists (ASA) I and II and age between 25 to 75 years will include. the exclusion criteria including any contraindication for spinal anesthesia, obesity (body mass index more than 35 kg/m2), Local infection at the injection site in the groin, previous surgery at the injection site, Injecting drug addicts, receiving any type of analgesic two hours before surgery, mental and psychological disorders,
multi-trauma fractures, a history of severe heart disease, a history of kidney and respiratory diseases, Liver disease, pregnancy and hematologic disorders.
Intervention groups
Fascia iliac block will be performed in the intervention group using 20 cc of bupivacaine 0.25 with 0.5 cc of dexmedetomidine 50μg and in the control group using only 20 cc of bupivacaine 0.25.
Main outcome variables
Duration of analgesia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170515033986N4
Registration date:2022-03-24, 1401/01/04
Registration timing:prospective
Last update:2022-03-24, 1401/01/04
Update count:0
Registration date
2022-03-24, 1401/01/04
Registrant information
Name
Nazli Karami
Name of organization / entity
Urmia University of Medical Siences
Country
Iran (Islamic Republic of)
Phone
+98 44 3346 9932
Email address
karami.n@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-05, 1401/01/16
Expected recruitment end date
2022-07-22, 1401/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of using dexmedetomidine in fascia iliaca block on postoperative analgesia in patients undergoing femoral fractures surgery
Public title
The effect of dexmedetomidine on postoperative analgesia in patients undergoing femoral fracture surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with femoral fracture surgery under spinal anesthesia
Patients with ASA I and ASA II
Age between 25 to 75 years
Exclusion criteria:
Any contraindication for spinal anesthesia
Obesity (body mass index more than 35 kg/m2)
Local infection at the injection site in the groin
Previous surgery at the injection site
Injecting drug addicts
Receiving any type of analgesic two hours before surgery
Mental and psychological disorders
Multi-trauma fractures
A History of severe heart disease
A history of kidney and respiratory diseases
Liver disease
Pregnancy
Hematologic disorders
Age
From 25 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be divided into intervention and control groups using permuted block randomization based on generated numbers by random allocation software (20 blocks of 4 letters).
Blinding (investigator's opinion)
Double blinded
Blinding description
Current study is a double blind study. The patient and the person who will be assessed the outcomes (anesthesia assistant) will be blind about the intervention or control groups. therefore, the drugs will be drawn and coded inside the syringes by an anesthesiologist, and the block will be performed by an anesthesia assistant that who is unaware of the contents of the syringes.
Placebo
Not 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
2021-10-30, 1400/08/08
Ethics committee reference number
IR.UMSU.REC.1400.268
Health conditions studied
1
Description of health condition studied
Analgesia in femoral fractures
ICD-10 code
G89.1
ICD-10 code description
Acute pain, not elsewhere classified
Primary outcomes
1
Description
Duration of analgesia
Timepoint
The duration of analgesia until the onset of pain felt by the patient in 24 hours after surgery
Method of measurement
timing
2
Description
Prescribing an analgesic
Timepoint
Prescribing an analgesia in recovery, 2, 6, 12 and 24 hours after surgery
Method of measurement
Patient request
Secondary outcomes
1
Description
Time to Prescription an analgesic
Timepoint
24 hours after surgery
Method of measurement
Timing
2
Description
Pain severity
Timepoint
In recovery, 2, 6, 12 and 24 hours after surgery
Method of measurement
Visual Analog Scale (VAS)
3
Description
Complications of Iliaca fascia block
Timepoint
In recovery, 2, 6, 12 and 24 hours after surgery
Method of measurement
Clinical examination
Intervention groups
1
Description
Intervention group: Iliaca fascia block will beperformed using 20 cc of bupivacaine 0.25% with 0.5 cc of dexmedetomidine 50μg.
Category
Treatment - Drugs
2
Description
Control group: Iliaca fascia block will be performed using only 20 cc of bupivacaine 0.25%.
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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
No - There is not a plan to make this available
Title and more details about the data/document
The results of the study will be available as an article. Other files, including data and the consent form, can also be accessed through email address of corresponding author.
When the data will become available and for how long
after published article
To whom data/document is available
researchers
Under which criteria data/document could be used
The data can be provided for use in meta-analysis, network meta-analysis or any secondary analysis with research purposes.
From where data/document is obtainable
corresponding author (Nazli Karami). Data will be available by sending an email to karami.n@umsu.ac.ir
What processes are involved for a request to access data/document