| CTRI Number |
CTRI/2024/07/070165 [Registered on: 08/07/2024] Trial Registered Prospectively |
| Last Modified On: |
27/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical study to compare which has better pain relief pericapsular nerve group block versus suprainguinal fascia iliaca block after the surgery in patients undergoing hip surgery. |
|
Scientific Title of Study
|
Compare analgesic efficacy of USG guided pericapsular nerve group block versus suprainguinal fascia iliaca block for post operative pain relief in hip surgery |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Simran Rana |
| Designation |
Pg resident 2nd year |
| Affiliation |
Pt jnm medical college raipur cg |
| Address |
Dept of anesthesiology and pain medicine,pt jnm medical college, raipur(cg)
Raipur
CHHATTISGARH
492001
India |
| Phone |
9131288850 |
| Fax |
|
| Email |
simranrana177@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pratibha Jain Shah |
| Designation |
Professor and Head of Department |
| Affiliation |
Pt JNM Medical College Raipur CG |
| Address |
Department of Anesthesiology and Pain Medicine , Pt JNM Medical College, Raipur CHHATTISGARH
Raipur
CHHATTISGARH
492001
India |
| Phone |
9827276620 |
| Fax |
|
| Email |
prati_jain@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Simran Rana |
| Designation |
Pg resident 2nd year |
| Affiliation |
Pt jnm medical college raipur cg |
| Address |
Dept of anesthesiology and pain medicine,pt jnm medical college, raipur(cg)
Raipur
CHHATTISGARH
492001
India |
| Phone |
9131288850 |
| Fax |
|
| Email |
simranrana177@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia and Pain Medicine Pt JNM Medical College Raipur in front of central jail Moudhapara RAIPUR C.G. pincode :492001 INDIA |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesia and Pain Medicine Pt JNM Medical College Raipur |
| Address |
In front of central jail Moudhapara Raipur C.G. Pincode: 492001 INDIA |
| 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 Simran Rana |
Dr. Bhimrao Ambedkar Memorial Hospital Raipur |
Department of Anaesthesiology and Pain Medicine, Pt JNM Medical College/ Major OT second floor Raipur
Raipur
CHHATTISGARH |
9131288850
simranrana177@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Pt J.N.M. Medical college raipur (C.G.) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Pericapsular nerve group block (PENG) |
Group A will receive pericapsular nerve group block 20 ml 0.5% bupivacaine and effect will be seen for 24 hours |
| Comparator Agent |
Suprainguinal fascia iliaca block (SFIB) |
Group B will receive suprainguinal fascia iliaca block,20 ml 0.5% bupivacaine and effect will be seen for 24 hours |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1-3,Patients scheduled for unilateral hip surgery |
|
| ExclusionCriteria |
| Details |
1. Patient refusal
2. Surgery more than 150 min
3. Coagulation or bleeding disorder
4. Allergy to local anaesthetics
5. Presence of other fracture requiring surgery
6. Morbid obesity
7. Pre-existing uncontrolled cardiovascular disease, renal failure, hepatic failure |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Duration of pain relief assessment |
Time to first requirement of analgesics will be noted post operative till 24hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Total analgesic requirement in 24 hrs postoperatively.
2.Intensity of pain relief assessment by VAS score at 0,2,4,8,12,24 hours.
3. Patients satisfaction score.
4. Incidence of failed block.
5. Incidence of procedure and drug related complications. |
Intensity of pain relief assessment by VAS score at 0,2,4,8,12,24 hours. |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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 4 |
|
Date of First Enrollment (India)
|
08/07/2024 |
| 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)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Written informed consent will be taken from patients undergoing hip surgery under SAB between 25-75 years Patients will be randomly allocated into two groups Group A will receive pericapsular nerve group block and Group B will receive suprainguinal fascia iliaca block To avoid bias patient and observer will be unaware of the type of block given Time to first requirement of analgesics will be noted Total analgesic requirement in 24 hours, VAS score assessment for severity of pain, patient’s satisfaction score and procedure or drug related complications noted |