Protocol summary

Study aim
The comparison of the efficacy of ultrasonographic-guided pericapsular block vs. fascia iliaca block for controlling pain after intertrochanteric fracture surgery
Design
This study is a clinical trial with a control group, double-blind, randomized, on 30 patients using block randomization method.
Settings and conduct
After surgery and transfer of the patient to recovery and lowering the level of spinal anesthesia, to perform precapsular block, first the ultrasound probe is kept in the superior anterior path of the iliac spine and parallel to the inguinal ligament and gently towards the caudal It moves at the same angle. Immediately after the probe reaches the iliac spine inferior anterior, the sono probe is rotated toward the medial so that the upper pubis ramus is visible. In this case, we hold the sono probe fixed. 20cc Ropivacaine 0.25% is injected at this site with a Spinal needle No. 22. In the Iliaca fascia block, under ultrasound guidance , the patient is placed in the supine position, the probe is placed transversely above the inguinal ligament and parallel to it. The needle is inserted laterally into the medial and 20 cc of Ropivacaine 0.25% is injected between the iliac fascia and the iliac muscle. Also, for patients, an intravenous pain control pump containing fentanyl is placed and the request hours are recorded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients 40 to 80 years old, Patients with an anesthesia score of 1 to 3 Exclusion criteria: Candidates for emergency surgery, History of rupivacaine allergy, Liver and kidney problems
Intervention groups
Intervention group: Pericapsular block in patients undergoing intertrochanteric fracture surgery Comparison group: Ilia fascia block in patients undergoing intertrochanteric fracture surgery
Main outcome variables
Pain, satisfaction, nausea and vomiting

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20141127020112N11
Registration date: 2021-10-12, 1400/07/20
Registration timing: registered_while_recruiting

Last update: 2021-10-12, 1400/07/20
Update count: 0
Registration date
2021-10-12, 1400/07/20
Registrant information
Name
Pooya Derakhshan
Name of organization / entity
Birjand Univesity of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 56 3234 1410
Email address
pooya_derakhshan@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-23, 1400/07/01
Expected recruitment end date
2022-03-20, 1400/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of the efficacy of ultrasonographic-guided pericapsular block vs fascia iliaca block for controlling pain after intertrochanteric fracture surgery
Public title
The effect of pericapsular block vs Iliaca fascia block on pain control after intertrochanteric fracture surgery.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients 40 to 80 years old are candidates for intertrochanteric fracture surgery. Patients with an anesthesia score of 1 to 3
Exclusion criteria:
Candidates for emergency surgery History of rupivacaine allergy Liver and kidney problems
Age
From 40 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
  • Care provider
  • Data analyser
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, we use the block randomization method so that after selecting patients according to the inclusion and exclusion criteria by selecting numbers from the table of random numbers and adapting to the blocks, patients are divided into study groups. To randomize the two treatment methods, we create 4 blocks in six different states, then select a number using the table of numbers, and determine the study groups by matching the numbers with the blocks. For example, if the first digit of our number is 1 to 6, select a block and the division is done, but if, for example, our number is 94071, the digit 9 is not valid and we select the next digit. Here, based on the block 4, we divide patients into groups. 1. TTCC 2. TCTC 3. TCCT 4. CCTT 5. CTCT 6. CTTC
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, people who are responsible for patient care and analysis of statistical data do not know about the treatment process and study groups, and information is provided to them in groups A and B.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences., Hemmat Highway., Next to Milad Tower., Tehran Town
City
Tehran
Province
Tehran
Postal code
8874113911
Approval date
2021-04-21, 1400/02/01
Ethics committee reference number
IR.IUMS.FMD.REC.1400.067

Health conditions studied

1

Description of health condition studied
intertrochanteric fracture
ICD-10 code
S72.14
ICD-10 code description
Intertrochanteric fracture of femur

Primary outcomes

1

Description
Pain
Timepoint
After surgery
Method of measurement
Visual Analogue Scale

2

Description
Satisfaction
Timepoint
After surgery
Method of measurement
Check list

Secondary outcomes

1

Description
Nausea and Vomiting
Timepoint
After surgery
Method of measurement
Check list

Intervention groups

1

Description
Intervention group 1: After surgery and transfer of the patient to recovery and lowering the level of spinal anesthesia, to perform precapsular block, first the ultrasound probe is kept in the superior anterior path of the iliac spine and parallel to the inguinal ligament and gently towards the caudal It moves at the same angle. Immediately after the probe reaches the iliac spine inferior anterior, the sono probe is rotated toward the medial so that the upper pubis ramus is visible. In this case, we hold the sono probe fixed. 20cc Ropivacaine 0.25% (Molteni Farmaceutici)is injected at this site with a Spinal needle No. 22.
Category
Treatment - Other

2

Description
Intervention group 2 : In the Iliaca fascia block, under ultrasound guidance , the patient is placed in the supine position, the probe is placed transversely above the inguinal ligament and parallel to it. The needle is inserted laterally into the medial and 20 cc of Ropivacaine 0.25% (Molteni Farmaceutici) is injected between the iliac fascia and the iliac muscle.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Rasoul Akram Hospital
Full name of responsible person
Pooya Derakhshan
Street address
No 18, Yas St., Ghafari Ave.
City
Tehran
Province
Tehran
Postal code
8874113911
Phone
+98 56 3234 1410
Email
pooyaderakh@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyyed Abass Motavalian
Street address
Iran University of Medical Sciences., Hemmat Highway., Next to Milad Tower., Tehran Town
City
Tehran
Province
Tehran
Postal code
8874113911
Phone
+98 21 8670 5503
Email
motevalian@aiums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Pooya Derakhshan
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
No 18, Yas St., Ghafari Ave.
City
Tehran
Province
Tehran
Postal code
8874113911
Phone
+98 56 3234 1410
Email
pooyaderakh@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Pooya Derakhshan
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
No 18, Yas St., Ghafari Ave.
City
Tehran
Province
Tehran
Postal code
8874113911
Phone
+98 56 3234 1410
Email
pooyaderakh@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Pooya Derakhshan
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
No 18, Yas St., Ghafari Ave.
City
Tehran
Province
Tehran
Postal code
8874113911
Phone
+98 56 3234 1410
Email
pooyaderakh@yahoo.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
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