The objective of this study is to compare the block quality along with sensory and motor characteristics when comparing the pericapsular nerve block (PENG) with the fascia iliaca block in patients undergoing total hip arthroplasty.
Design
Single blind, randomized by non-probability consecutive sampling via lottery method assessing post-operative pains scores after the two techniques in a single center study
Settings and conduct
Will be done according to the inclusion criteria given.
Patients undergoing total hip arthroplasty will be undergoing one of the two blocks (PENG or FIB) pre-operatively according to standard methods of NYSORA
Patients will be blinded to the block performed by the consultant anesthetist
Post-operative pain scores and time to patient mobilization will be the primary variables studied
Participants/Inclusion and exclusion criteria
Inclusion criteria included all ASA-II male and female patients above the age of fifty years requiring total hip arthroplasty (THA) due to advanced osteoarthritis of the hip joint.
Exclusion criteria included patients with major cardiac or respiratory debility, metastatic bone disease, allergy to drugs used for the block, bleeding diathesis, coagulation defects, patients with patchy or failed block after administration and patients not willing to be included in the study.
Intervention groups
Group F (receiving fascia iliac block)
Group P (receiving PENG block)
Main outcome variables
Mean time for first dose of rescue analgesia,
Mean time to patient mobilization
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230809059091N2
Registration date:2023-08-16, 1402/05/25
Registration timing:registered_while_recruiting
Last update:2023-08-16, 1402/05/25
Update count:0
Registration date
2023-08-16, 1402/05/25
Registrant information
Name
Nabeel Butt
Name of organization / entity
Combined Military Hospital Rahim Yar Khan
Country
Pakistan
Phone
+92 313 5969696
Email address
nabeel4allz@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-09, 1402/05/18
Expected recruitment end date
2023-11-09, 1402/08/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
COMPARISON OF THE NOVEL PENG (PERICAPSULAR NERVE GROUP) BLOCK VERSUS FASCIA ILIACA BLOCK (FIB) IN PATIENTS UNDERGOING TOTAL HIP ARTHROPLASTY
Public title
PENG VERSUS FIB
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Included all ASA-II (American society of Anaesthesiologists) male and female patients above the age of fifty years
Requiring total hip arthroplasty (THA) due to advanced osteoarthritis of the hip joint.
Exclusion criteria:
Excluded patients with major cardiac or respiratory debility, metastatic bone disease, allergy to drugs used for the block, bleeding diathesis, coagulation defects, patients with patchy or failed block after administration and patients not willing to be included in the study.
Metastatic bone disease
Allergy to the drugs used in the block (lignocaine)
Bleeding diathesis and coagulation disorders
Patients with patchy or failed block after administration
Patients not willing to be included in the study
Age
From 50 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
Non-probability consecutive sampling by lottery method into the two interventional groups
Blinding (investigator's opinion)
Single blinded
Blinding description
Single blind with the patient unaware of the block type done
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical review board Combined Military Hospital Rahim Yar khan
Street address
Chowk Bahadarpur
City
Rahim Yar Khan
Postal code
64200
Approval date
2023-08-01, 1402/05/10
Ethics committee reference number
00100
Health conditions studied
1
Description of health condition studied
Pain with total hip arthroplasty due to osteoarthritis
ICD-10 code
M16
ICD-10 code description
Osteoarthritis of hip
Primary outcomes
1
Description
Mean time for first dose of rescue analgesia and mean time to patient mobilization
Timepoint
Within 12 hours post-surgery
Method of measurement
Standard Visual Analog scale for pain assessment
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Group F (Fascia iliac block group) will receive the block pre-operatively in the operating room with the patient unaware of the block performed by a consultant anesthetist with at least 5 years of experience under ultrasound guidance administering 20 ml of local anesthetic (2% ligonicaine) in the facia iliac plane. After surgery median pain scores assessment would be done by standard visual analog scale at 3,6,12 and 24 hour duration along with time to patient mobilization
Category
Treatment - Other
2
Description
Intervention group: Group P (pericapsular nerve group block) will receive the block pre-operatively in the operating room with the patient unaware of the block performed by a consultant anesthetist with at least 5 years of experience under ultrasound guidance administering 20 ml of local anesthetic (2% ligonicaine) in the pericapsular space and blocking corresponding nerves. After surgery median pain scores assessment would be done by standard visual analog scale at 3,6,12 and 24 hour duration along with time to patient mobilization
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Combined Military Hospital Rahim Yar Khan
Full name of responsible person
Dr. Nabeel Tahir Butt
Street address
Chowk Bahadarpur
City
Rahim Yar Khan
Postal code
64200
Phone
+92 313 5969696
Email
nabeel4allz@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
CMH Rahim Yar Khan
Full name of responsible person
Dr. Nabeel Tahir Butt
Street address
Chowk Bahadarpur
City
Rahim Yar Khan
Postal code
64200
Phone
+92 313 5969696
Email
nabeel4allz@gmail.com
Grant name
None
Grant code / Reference number
None
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
None
Proportion provided by this source
1
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
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Combined Military Hospital Rahim Yar Khan
Full name of responsible person
Nabeel Butt
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Chowk Bahadarpur
City
Rahim Yar Khan
Province
Punjab
Postal code
64200
Phone
+92 313 5969696
Fax
Email
nabeel4allz@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Combined Military Hospital Rahim Yar Khan
Full name of responsible person
Dr. Nabeel Tahir Butt
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Chowk Bhadarpur
City
Rahim Yar Khan
Province
Punjab
Postal code
64200
Phone
+92 313 5969696
Email
nabeel4allz@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Combined Military Hospital Rahim Yar Khan
Full name of responsible person
Dr. Nabeel Tahir Butt
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Chowk Bhadarpur
City
Rahim Yar Khan
Province
Punjab
Postal code
64200
Phone
+92 313 5969696
Email
nabeel4allz@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
Not applicable
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Output SPSS sheets and all excel data sets
When the data will become available and for how long
After approval of the manuscript by the journal
To whom data/document is available
Everyone open access
Under which criteria data/document could be used
The study data including excel sheets and SPSS output files can be used after permission from the primary author who would receive the application for data use via email
From where data/document is obtainable
The data will be uploaded on the Google drive of the primary author with the email (nabeel4allz@gmail.com) and will be available after a formal email request
What processes are involved for a request to access data/document
A formal email on the address given to the primary author of the article. Any queries asked by the author would be done through email and link to the data from google drive would be sent after author approval (usual time till approval is 7 days)