The comparison of pericapsular nerve group block (PENG block) with fascia iliaca block on opioid intra-operative consumption and post-operative analgesic effects in extra-capsular and intra-capsular hip fracture
- The Comparison of pericapsular nerve group block (PENG block) with Fasia iliac block on opioid intraoperative consumption and post-operative analgesic effects in extra capsular and intracapsular hip fracture
Design
A randomized controlled clinical trial with parallel groups, Double blinded
Settings and conduct
After approval by the ethics committee of Shahid Beheshti University of Medical Sciences and obtaining patient satisfaction, 36 patients aged between 50-75 years and ASA class I and II, who are candidates for femoral neck fracture or intertrochanteric fracture surgery, will be randomly assigned to 2 groups according to the table of random numbers.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
- Patients with hip fractures (femoral neck and intertrochanteric fractures) aged 50-75 years and ASA Class I and II
- Elective surgery
- Hemoglobin levels above 9 mg / dl
Exclusion criteria:
- Other fractures or other lesions require surgery
- History of drug or psychotropic addiction
- Presence of psychiatric illnesses
- Existence of coagulation disorder or contraindication to spinal anesthesia
- Sensitivity to local anesthetics
- Nervous disorders in the nerves of the lower extremities
Intervention groups
First intervention group: After prep , with a 2 cc syringe with a 1% Lidocaine injection, with the help of a high-frequency linear transducer, an in-plane ultrasound machine with a B Brain needle of 3 ml / kg and a maximum of 40 cc Rupivacaine is injected directly between the fascia iliac and the iliopsoas muscle.
Second intervention group: Patient group with pericapsular nerve block: PENG is given to each patient under the guidence of low frequency, Curvilinear probe that is Horizontally placed over Anterior inferior iliac spine.
Main outcome variables
intra-operative opioid consumption; Pain
General information
Reason for update
Acronym
PENG
IRCT registration information
IRCT registration number:IRCT20200314046763N1
Registration date:2020-05-11, 1399/02/22
Registration timing:registered_while_recruiting
Last update:2020-05-11, 1399/02/22
Update count:0
Registration date
2020-05-11, 1399/02/22
Registrant information
Name
Hamidreza Samadpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4460 4203
Email address
hamidrezasamadpour@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-20, 1399/01/01
Expected recruitment end date
2021-07-28, 1400/05/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of pericapsular nerve group block (PENG block) with fascia iliaca block on opioid intra-operative consumption and post-operative analgesic effects in extra-capsular and intra-capsular hip fracture
Public title
Evaluation of the effect of pre-capsular nerve group block on opoid intra-operative consumption and analgesic effects after hip fracture surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with hip fractures
Elective surgery
Hemoglobin levels above 9 mg / dl
Age 50 to 75 years
ASA class I and II patients
Exclusion criteria:
Other fractures or other lesions require surgery
History of drug or psychotropic addiction
Presence of psychiatric illnesses
Existence of coagulation disorder
Sensitivity to local anesthetics
Nervous disorders in the nerves of the lower extremities
Age
From 50 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
Accidentalization was performed using block randomization method with 9 blocks and 2, 4, 6, 8 in blocks using blockrand package in R software.
Blinding (investigator's opinion)
Double blinded
Blinding description
In the first step, the first and second intervention groups will be placed in the envelope. The study is double blind in that the patient will not be aware of the type of treatment, the evaluator will be different from the therapist, and the evaluator will be uninformed, but the therapist will be aware of the treatment. The evaluator will examine the patients at the beginning of their visit and refer them to a therapist if they have the conditions to study, and the therapist will select the treatment envelope according to the random block method. In the next step, the evaluator will perform the evaluation without knowing the assigned method.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Iran national committee for Ethics in biomedical research
Street address
Tehran - Qods Township (West) - 13th Floor Between South Flamak and Zarafshan, Iran Sime St. - Headquarters of Ministry of Health and Medical Education, Block A
City
Tehran
Province
Tehran
Postal code
11111111
Approval date
2019-05-14, 1398/02/24
Ethics committee reference number
IR.SBMU.MSP.REC.1398.133
Health conditions studied
1
Description of health condition studied
Pericapsular Nerve Group (PENG) block
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
pain
Timepoint
6, 12 and 24 hours after surgery
Method of measurement
Visual Analog Scale(VAS)
2
Description
opioid intra-operative consumption
Timepoint
At the beginning of the surgery and then every 15 minutes
Method of measurement
Numeric rating scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: PENG nerve block in intraoperative drug use and postoperative analgesic effects in intra-capsular and extracapsular hip fracture groups.After sterilizing the site and performing a skin anesthesia, the curve linear, low-frequency (2-5 MHz) is taken transversely on the Anterior Inferior iliac Spine, by rotating 45 degrees counterclockwise. The femoral artery and pectinus muscle are seen. The nidel is like the nidel of the control group and is inserted from the lateral to the medial in an in-plane so that its tip is located in the fascial muscle between the posterior psoas tendon and the posterior Ramus pubis after aspiration. Negative 0.5% vacuum solution is injected at 3 ml / kg with aspiration every 5 cc.
Category
Rehabilitation
2
Description
Control group: Patients with Fascia Iliaca Neural Block: Patients who undergo vital signs and appropriate intravenous lineage after receiving transfer to the operating room and monitoring with normal saline intake of 5-5 cc / kg, will undergo the following Fascia Iliaca nerve block as follows: Sterilize the block site and perform a skin anesthesia with a 2 cc Needle syringe with 1% lidocaine injection, with the help of a high-frequency linear transducer (10-25 MHz ultrasound device (S-Nerve Sonosite)) that is placed horizontally in the inguinal area. In-plan and with needle (B Brain (22 G, 80 mm, Stimuplex Ultra 360 in the amount of 3 ml / kg and a maximum of 40 ml of Rupivacaine 0.5% (Multeni) with direct view between the fascia The iliac and iliopsoas muscles are injected.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Medical Center Hospital Imam Hussein
Full name of responsible person
Alireza mirkhesti
Street address
Tehran, Martyr Madani Ave., lower than Martyr Madani Metro, Imam Hussein Medical, Educational, Research and Medical Center.
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7343 0000
Email
info@ehmc.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Afshin Zarghi
Street address
Tehran - Yemen St. Martyr Chamran Highway - Shahid Arababi Street Next to Ayatollah Taleghani Hospital
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 23871
Fax
+98 21 2243 9981
Email
Mpajouhesh@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
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
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
Title and more details about the data/document
All potential data can be shared after unidentifiable people
When the data will become available and for how long
Start of access period 6 months after printing results
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
1. Respecting the ethics and religion of the patients who participate in these studies.
2-To help improve the validity of the data produced.
3. Assist physicians in interpreting and minimizing disruption to clinical trials.
4. Prevent the recruitment of volunteers who are exposed to the dangers of high-risk trials.
5. Mass media information on the effects of trials that do not conform to the interests of pharmaceutical companies.
From where data/document is obtainable
drhamidrezasamadpour@gmail
00989125395847
What processes are involved for a request to access data/document
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