| CTRI Number |
CTRI/2025/11/097418 [Registered on: 13/11/2025] Trial Registered Prospectively |
| Last Modified On: |
13/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of Ultrasound-guided various blocks in postoperative pain in hip arthroplasty |
|
Scientific Title of Study
|
Ultrasound-guided supra-inguinal fascia iliaca block (SI-FICB) vs ultrasound-guided pericapsular nerve group block (PENGB) vs epidural analgesia for postoperative pain in hip arthroplasty |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Karan juyal |
| Designation |
Junior resident |
| Affiliation |
Gsvm medical College |
| Address |
Department of Anesthesiology and critical care Gsvm medical College kanpur
Department of Anesthesiology and critical care
Kanpur Nagar
UTTAR PRADESH
208002
India |
| Phone |
9084401231 |
| Fax |
|
| Email |
karanjuyal.158@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Apurva Agarwal |
| Designation |
Professor |
| Affiliation |
Gsvm medical College |
| Address |
Department of Anesthesiology and critical care Gsvm medical College kanpur
Department of Anesthesiology and critical care
Kanpur Nagar
UTTAR PRADESH
208002
India |
| Phone |
9415368678 |
| Fax |
|
| Email |
drapurva.agarwal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Apurva Agarwal |
| Designation |
Professor |
| Affiliation |
Gsvm medical College |
| Address |
Department of Anesthesiology and critical care Gsvm medical College kanpur
Department of Anesthesiology and critical care
UTTAR PRADESH
208002
India |
| Phone |
9415368678 |
| Fax |
|
| Email |
drapurva.agarwal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesiology and critical care and pain medicine gsvm medical College kanpur uttar pradesh India 208002 |
|
|
Primary Sponsor
|
| Name |
Department of Anesthesiology and critical care and pain medicine |
| Address |
Department of Anesthesiology and critical care and pain medicine gsvm medical College kanpur uttar pradesh India 208002 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Apurva Agarwal |
LLR Hospital |
Department of Anesthesiology and critical care and pain medicine gsvm medical College
Kanpur Nagar
UTTAR PRADESH |
9415368678
drapurva.agarwal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee gsvm medical college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M95||Other acquired deformities of musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ultrasound-guided supra-inguinal fascia iliaca block (SI-FICB) vs ultrasound-guided pericapsular nerve group block (PENGB) vs epidural analgesia |
Ultrasound-guided supra-inguinal fascia iliaca block (SI-FICB) vs ultrasound-guided pericapsular nerve group block (PENGB) vs epidural analgesia for postoperative pain in hip arthroplasty 3,6,12,24,48 hours |
| Intervention |
Ultrasound-guided supra-inguinal fascia iliaca block (SI-FICB) vs ultrasound-guided pericapsular nerve group block (PENGB) vs epidural analgesia |
Ultrasound-guided supra-inguinal fascia iliaca block (SI-FICB) vs ultrasound-guided pericapsular nerve group block (PENGB) vs epidural analgesia for postoperative pain in hip arthroplasty at 3,6,12,24,48 hours |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade I and II
Patients undergoing hip arthroplasty
after written informed consent |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Post operative pain management in hip arthroplasty patients |
30 min, 1 hour, 3 hours, 6 hours, 12 hours, 24 hours ,36 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare safety,efficacy and adverse effects of ultrasound-guided supra-inguinal fascia iliaca block (SI-FICB) vs ultrasound-guided pericapsular nerve group block (PENGB) vs epidural analgesia in hip arthroplasty patients |
30 mins
1hr
3 hr
6 hr
12 hr
24 hr
36 hr
48 hr |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
27/11/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Ultrasound guided supra inguinal fascia iliaca block versus ultrasound guided pericapsular nerve group block versus epidural analgesia in post operative pain control and safety in hip arthroplasty patients |