Comparing of the analgesic effect of pericapsular ultrasound-guided nerve group block and fascia iliaca block in patients with hip fracture for neuraxial block; a pilot study
Comparing of the analgesic effect of pericapsular ultrasound-guided nerve group block and fascia iliaca block in patients with hip fracture for neuraxial block as a pilot study
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 3 on 50 patients
Settings and conduct
This double-blind clinical trial study will be performed on 50 patients between the ages of 18-80 years in two groups (pericapsular nerve block and fascia iliac with ultrasound block) in Imam Khomeini hospital in Urmia. Pain will be checked before, 10 minutes after block and before positioning for neuraxial anesthesia using visual analog scale.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with hip fracture, American Society of Anesthesiologists (ASA) I and II, Lack of deformity in spinal, Age between 18 to 80 years; Exclusion criteria: Having heart disease, Sensitivity to local anesthetics, Coagulopathy disorders
Intervention groups
Intervention group 1: Pericapsular ultrasound-guided nerve block
Intervention group 2: Fascia iliaca block
Main outcome variables
Pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170516033992N8
Registration date:2021-08-29, 1400/06/07
Registration timing:registered_while_recruiting
Last update:2021-08-29, 1400/06/07
Update count:0
Registration date
2021-08-29, 1400/06/07
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
2021-08-21, 1400/05/30
Expected recruitment end date
2022-01-20, 1400/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing of the analgesic effect of pericapsular ultrasound-guided nerve group block and fascia iliaca block in patients with hip fracture for neuraxial block; a pilot study
Public title
Analgesic effect of pericapsular nerve and fascia iliaca block in hip fracture
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Lack of deformity in spinal
American Society of Anesthesiologists (ASA) I and II
Age between 18 to 80 years
Exclusion criteria:
Having heart disease
Sensitivity to local anesthetics
Coagulopathy disorders
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
40 patients, using random allocation software, were randomly divided into pericapsular nerve block and fascia iliaca block groups. By selecting the simple randomization method in the randomization box and entering the determined total sample size in this software, numbers were given to the patients and the patients were allocated into two groups according to computer-generated numbers. The tool used is random allocation software version 2.0 in which by selecting the number of groups and the sample size, a random sequence sheet is provided for the control and intervention group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients and statistical analyzers were unaware of the patient was anesthetized using pericapsular nerve block and fascia iliaca block. Anesthesia was performed by an anesthesiologist in the operating room for randomly selected patients. In this way, the patient was only aware that the block was performed on him/her, but was unaware of its type, and also the statistical analyzer will receive the data in code A and B for the two intervention groups.
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
No30., Jahad Sq., Resalat St., Urmia University of Medical Sciences, Urmia, Iran
City
Urmia
Province
West Azarbaijan
Postal code
5715833631
Approval date
2021-07-14, 1400/04/23
Ethics committee reference number
IR.UMSU.REC.1400.160
Health conditions studied
1
Description of health condition studied
Pain
ICD-10 code
G89
ICD-10 code description
Pain, not elsewhere classified
Primary outcomes
1
Description
Pain
Timepoint
Pain will be checked before, 10 minutes after block and before positioning for neuraxial anesthesia using visual analog scale
Method of measurement
Visual analog scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: In the precapsular block, 20 ml of bupivacaine 0.25% (produced by Tebshahr company) using an ultrasound guide for analgesia is injected deep into the plate between the muscle and the fascia, in front of which is the pseudos tendon and behind which is the pubic bone ramus, and the patient is in a supine position.
Category
Treatment - Drugs
2
Description
Intervention group 2: In the fascia iliac block, 20 ml of 0.25% (produced by Tebshahr company) bupivacaine using an ultrasound guide for analgesia is injected deep into the fascia iliac and in the upper lateral part of the iliac muscle, and the patient is in a supine position.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Tohid Karami
Street address
Jahad Sq., Resalat St., Urmia University of Medical Sciences
City
Urmia
Province
West Azarbaijan
Postal code
5715833631
Phone
+98 44 3348 9752
Fax
+98 44 3345 7287
Email
karami.tohid@gmail.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Iraj Mohebbi
Street address
No30., Jahad Sq., Resalat St., Uremia University of Medical Sciences, Uremia, Iran
City
Uremia
Province
West Azarbaijan
Postal code
5715833631
Phone
+98 44 3193 7224
Email
mohebbi_iraj@yahoo.co.uk
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia 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
Oroumia University of Medical Sciences
Full name of responsible person
Tohid Karami
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Jahad Sq., Resalat st., Urmia University of Medical Sciences
City
Urmia
Province
West Azarbaijan
Postal code
5715833631
Phone
+98 44 3193 7000
Fax
+98 44 3345 7287
Email
karami.tohid@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Tohid Karami
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Jahad Sq., Resalat st., Urmia University of Medical Sciences
City
Urmia
Province
West Azarbaijan
Postal code
5715833631
Phone
+98 44 3193 7000
Fax
+98 44 3345 7287
Email
karami.tohid@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Tohid Karami
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Jahad Sq., Resalat st., Urmia University of Medical Sciences
City
Urmia
Province
West Azarbaijan
Postal code
5715833631
Phone
+98 44 3193 7000
Fax
+98 44 3345 7287
Email
karami.tohid@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is 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
Yes - There is a plan to make this available
Title and more details about the data/document
Reporting of results as a published article
When the data will become available and for how long
After publishing of article
To whom data/document is available
Researchers
Under which criteria data/document could be used
As published article
From where data/document is obtainable
Corresponding author
What processes are involved for a request to access data/document
If necessary access to the data can be done through the e-mail address of the corresponding author that will be written in the published article.