Comparison of direct injection of Ropivacaine around the hip joint with pericapsular nerve group block (PENG) on opium consumption around the operation in patients undergoing Total hip Arthroplasty
Measuring the postoperative pain and opioid use in periarticular injection (PENG and direct) after total hip arthroplasty.
Design
A clinical trial with 2 groups, with parallel groups, double-blind, randomized, phase 3 on 128 patients. For randomization, a simple randomization method is used
Settings and conduct
After the approval of the ethics committee and obtaining the consent of the patients, 128 candidates for hip arthroplasty surgery at Imam Hossein Hospital who meet the entry criteria will be included in the study. Patients are assigned to one of the two groups by simple randomization. Individuals responsible for randomization from the research team will not be responsible for examining the dependent variable. The data analyst will not know about the coding of the groups.
Participants/Inclusion and exclusion criteria
Candidate for total hip arthroplasty
No history of pelvic surgery
No history of drug abuse and other psychoactive substances
No history of psychiatric disease
No allergy to local anesthetics
Unwillingness to participate in the study
Intervention groups
Ultrasound group: The method of inducing analgesia will be the PENG method, in which 20 ml of 0.25% ropivacaine will be injected laterally to medially with a standard 100 mm, 22-gauge needle at the level between the tendon of the psoas muscle and the ramus pubis.
Intervention group: 20 cc of 0.25% ropivacaine will be used and injected as a 5 ml injection into the ligamentum teres before stem placement, a five ml injection into the labrum after stem placement, and the remaining ten ml injection after capsular repair (5 ml into the capsule, 5 ml into the muscle).
Main outcome variables
Visual analog score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230204057318N7
Registration date:2024-12-17, 1403/09/27
Registration timing:prospective
Last update:2024-12-17, 1403/09/27
Update count:0
Registration date
2024-12-17, 1403/09/27
Registrant information
Name
Alireza Shakeri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7343 0000
Email address
dr.alirezashakeri@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-12-21, 1403/10/01
Expected recruitment end date
2025-04-20, 1404/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of direct injection of Ropivacaine around the hip joint with pericapsular nerve group block (PENG) on opium consumption around the operation in patients undergoing Total hip Arthroplasty
Public title
Comparison of direct injection and PENG
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Candidate for total hip arthroplasty
Exclusion criteria:
No history of pelvic surgery
No history of drug abuse and other psychoactive substances
No history of psychiatric disease
No allergy to local anesthetics
Unwillingness to participate in the study
Age
From 50 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
128
Randomization (investigator's opinion)
Randomized
Randomization description
Creating a random sequence using a simple randomization method using 120 cards (60 cards for each group) that are placed inside opaque sealed envelopes and will be shuffled by the patients before choosing.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patients and the person responsible for data collection and the person analyzing will be unaware of the coding. Only the anesthesiologist and orthopedic surgeon will be aware of the patient's group during surgery and will perform coding for each group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of School of Medicine - Shahid Beheshti University of Medical Sciences
Street address
Yaman st., Shahid Chamran Hwy.
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2024-12-03, 1403/09/13
Ethics committee reference number
IR.SBMU.MSP.REC.1403.528
Health conditions studied
1
Description of health condition studied
Pericapsular nerve group block
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain
Timepoint
At the times of entry to post-anesthesia care unit, 2, 6, 12, and 24 hours
Method of measurement
Visual Analogue Scale (VAS)
Secondary outcomes
1
Description
Total postoperative opioid consumption in 24h
Timepoint
After 24h
Method of measurement
Consumption volume of patient controlled analgesia (PCA) pump
Intervention groups
1
Description
Intervention group: The method of inducing analgesia will be the PENG method, in which 20 ml of 0.25% ropivacaine will be injected laterally to medially with a standard 100 mm, 22-gauge needle at the level between the tendon of the psoas muscle and the ramus pubis.
Category
Treatment - Surgery
2
Description
Intervention group: 20 cc of 0.25% ropivacaine will be used and injected as a 5 ml injection into the ligamentum teres before stem placement, a five ml injection into the labrum after stem placement, and the remaining ten ml injection after capsular repair (5 ml into the capsule, 5 ml into the muscle).
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein Hospital
Full name of responsible person
Alireza Shakeri
Street address
Shahid Madani st, Imam ali Hwy.
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7343 0000
Email
dr.alirezashakeri@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Shahid Beheshti University of Medical Sciences, Next to Taleghani Hospital, Yemen Street, Shahid Chamran Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2243 9331
Email
zarghi@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Alireza Shakeri
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Imam Hossein Hospital, Shahid Madani st.
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7343 0000
Fax
Email
dr.alirezashakeri@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Alireza Shakeri
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Imam Hossein Hospital, Shahid Madani st.
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7343 0000
Fax
Email
dr.alirezashakeri@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Alireza Shakeri
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Imam Hossein Hospital, Shahid Madani st.
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7343 0000
Fax
Email
dr.alirezashakeri@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