The purpose of this study was to evaluate and compare ultrasound-guided femoral nerve block and intravenous fentanyl administration in reliving the pain of the patient with hip fracture.
Design
This study was a clinical trial study with a control group, with parallel groups of one-way blind, randomized, phase 3 on 58 patients. Random number tables are also used for randomization.
Settings and conduct
This study is a clinical trial study that will be performed on 40 patients with unilateral isolated proximal femur fracture complaints referred to Shahid Bahonar Hospital in Kerman.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with unilateral isolated proximal femur fracture complaints and American Society of Anesthesiologists ( ASA ) score I and II. Exclusion criteria: Subjects with allergy to amide local anesthetics, peripheral neuropathy, analgesic taking 8 hours before surgery, previous block at the affected site, mental disorders, risk of hemorrhage, drug addiction, other concomitant fractures and a history of fracture at the same site, diabetics and patients who did not mention having pain
Intervention groups
The patients were divided into two groups using random number tables. The first group was evaluated for The National Reporting System for Adult Education (NRS) criteria (0 to 10) half an hour before fentanyl injection and then received intravenous fentanyl at a dose of 1.5 μg / kg. After the injection, the patient's pain status was assessed at 15-minute intervals. The second group (FNB) was also evaluated by NRS approach followed by injection of 20 ml of 2-percent lidocaine solution guided by ultrasonography.
Main outcome variables
the pain of the patient with hip fracture
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171009036661N4
Registration date:2020-06-17, 1399/03/28
Registration timing:retrospective
Last update:2020-06-17, 1399/03/28
Update count:0
Registration date
2020-06-17, 1399/03/28
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3335 6220
Email address
m.mayel@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2015-07-11, 1394/04/20
Expected recruitment end date
2015-07-31, 1394/05/09
Actual recruitment start date
2015-09-21, 1394/06/30
Actual recruitment end date
2015-12-20, 1394/09/29
Trial completion date
2015-12-31, 1394/10/10
Scientific title
Ultrasound-Guided Femoral Nerve Block and Intravenous Fentanyl in Pain Management of the Patients with Hip Fracture: A Comparative Study
Public title
Management of the Patients with Hip Fracture: A Comparative Study
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with unilateral isolated proximal femur fracture complaints
American Society of Anesthesiologists (ASA) score I and II
Exclusion criteria:
allergy to amide local anesthetics
peripheral neuropathy
analgesic taking 8 hours before surgery
previous block at the affected site
mental disorders
risk of hemorrhage
drug addiction
other concomitant fractures and a history of fracture at the same site
diabetics
patients who did not mention having pain
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
40
Actual sample size reached:
40
Randomization (investigator's opinion)
Randomized
Randomization description
In this study patients randomly divided to intervention and control groups using random allocation sequence with SAS statistical software. according to this method, a simple randomization list product and patients` involvement in each group determine base on their order entry in emergency ward. we used Sequentially numbered, sealed, opaque envelopes for allocation concealment. patients (individuals) were the randomization units.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, main investigator and outcome assessor were blinded due to the sedation procedure and sonography was performed in isolated room. The data analyser were also blinded because all checklist was without name and contained only a code.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kerman University of Medical Sciences
Street address
Vice chancellor research, Jahad blvd., Ebn-e sina st.,
City
Kerman
Province
Kerman
Postal code
7613747181
Approval date
2015-08-07, 1394/05/16
Ethics committee reference number
IR.KMU.REC.1394.373
Health conditions studied
1
Description of health condition studied
Acute pain due to unilateral isolated proximal femur fracture complaints
ICD-10 code
G89.11
ICD-10 code description
Acute pain due to trauma
Primary outcomes
1
Description
the pain of the patient with hip fracture
Timepoint
0, 15, 30, 45 and 60 minutes after intervention
Method of measurement
Numerical rating scale for pain
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients who were evaluated for The National Reporting System for Adult Education (NRS) criteria (0 to 10) half an hour before fentanyl injection and then received intravenous fentanyl at a dose of 1.5 μg / kg. After the injection, the patient's pain status was assessed at 15-minute intervals
Category
Treatment - Other
2
Description
Control group: Patients were also evaluated by NRS approach followed by injection of 20 ml of 2-percent lidocaine solution guided by ultrasonography
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid bahonar hospital
Full name of responsible person
Masoud Mayel
Street address
Shahid Bahonar Hospital, Qarani St.
City
Kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3223 5011
Email
masoud.mayel@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr. Abbas Pardakhty
Street address
Vice chancellor of research, Ebn-e sina st., Jahad blvd.
City
Kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3223 5011
Email
abpardakhty@kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Dr. Massoud mayel
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Shahid Bahonar hospital, Qarani st.
City
Kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3223 5011
Email
masoud.mayel@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr. Massoud mayel
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Shahid Bahonar hospital, Qarani st.
City
Kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3223 5011
Email
masoud.mayel@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr. Massoud mayel
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Shahid Bahonar hospital, Qarani st.
City
Kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3223 5011
Email
masoud.mayel@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
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