| CTRI Number |
CTRI/2023/04/051338 [Registered on: 06/04/2023] Trial Registered Prospectively |
| Last Modified On: |
05/04/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
effect of pericapsular nerve group block vs fascia iliaca block done with USG in patients of hip fractures for pain relief before surgery |
|
Scientific Title of Study
|
Comparative study to evaluate effect of usg guided pericapsular nerve group block versus suprainguinal fascia iliaca block for postoperative analgesia in patients of hip fractures undergoing surgery under spinal anaesthesia. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Disha Juneja |
| Designation |
Junior Resident |
| Affiliation |
Mahatma Gandhi Medical College and Hospital,Sitapura |
| Address |
OT COMPLEX,2nd floor, department of anesthesia, Mahatma Gandhi Medical college,Jaipur
Mahatma Gandhi Medical College and Hospital,Sitapura
Jaipur
RAJASTHAN
302022
India |
| Phone |
7976812123 |
| Fax |
|
| Email |
dishajuneja36@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kalpana Verma |
| Designation |
Associate Professor |
| Affiliation |
Mahatma Gandhi Medical College and Hospital,Sitapura |
| Address |
OT Complex 2nd Floor Department of Anaesthesia, Mahatma Gandhi Hospital,Jaipur
Mahatma Gandhi Medical College and Hospital,Sitapura
Jaipur
RAJASTHAN
302022
India |
| Phone |
7727886029 |
| Fax |
|
| Email |
kalpana2007.kv@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Disha Juneja |
| Designation |
Junior Resident |
| Affiliation |
Mahatma Gandhi Medical College and Hospital,Sitapura |
| Address |
OT complex 7,8 orthopedics ot ,department of Anaesthesia,jaipur
Mahatma Gandhi Medical College and Hospital,Sitapura
Jaipur
RAJASTHAN
302022
India |
| Phone |
7976812123 |
| Fax |
|
| Email |
dishajuneja36@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Medical college and hospital |
|
|
Primary Sponsor
|
| Name |
Mahatma Gandhi Medical College and Hospital |
| Address |
Mahatma Gandhi Medical College and Hospital, Sitapura Tonk road,Jaipur |
| Type of Sponsor |
Private 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 Disha Juneja |
Mahatma Gandhi Medical College And Hospital, Sitapura |
Orthopedic OT 7 and 8 general ot complex, 2 floor,Mahatma Gandhi Hospital, Sitapura Tonk road,Jaipur
Jaipur
RAJASTHAN |
07976812123
dishajuneja36@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DR RAJENDRA KUMAR SUREKHA, MEMBER SECRETARY, IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M959||Acquired deformity of musculoskeletal system, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Pericapsular nerve group block |
In group PENG,patient is in the supine position,the usg probe is placed on a transverse plane over anterior superior iliac spine.Once the ASIS is identified,the transducer is aligned with the pubic ramus and rotated at approximately 45 degrees,parallel to the inguinal crease.The transducer is then slide medially along this axis until the anterior inferior iliac spine ,iliopubic eminence and psoas tendon is clearly identified ,serving as anatomic landmarks.Sliding the probe distally or gently tilting towards caudal will expose head of femur.Returning to initial starting position,a standard 20-22 gauge 100mm needle is inserted in-plane from lateral to medial,in the plane between psoas tendon and pubic ramus.20 ml of 0.5% Ropivacaine will be then deposited in this plane,lifting the psoas tenson.Care should be taken to avoid puncturing the psoas tendon or femoral vessels. Patient will be followed up for next 24 hours after the block. |
| Intervention |
Suprainguinal Fascial Iliaca Plane Block |
In group S-FICB,the patient is positioned supine with extended hip, and any abdominal
pannus is retracted by an assistant or heavy tape. The anterior superior iliac spine
(ASIS) is palpated and the ultrasound probe is placed slightly inferior and medial to it.
A high-frequency linear ultrasound probe is typically sufficient, although a lower
frequency curvilinear probe may be desirable for obese patients, as it is sometimes
helpful to begin imaging at sufficient depth to identify the ilium at the bottom of the
image. The iliacus muscle is identified superficial to the ilium, and the hyperechoic
fascia iliaca is identified on the superficial border of the muscle. Superficial to the
fascia iliaca, one can visualize where the abdominal wall muscles meet those of the
lower extremity at the inguinal ligament.The tapered confluence of the internal oblique
(cephalad) and the sartorius (caudad) at the inguinal ligament has been described as a
bow tie or horizontal hourglass sitting atop the iliacus muscle at the level of the
anterior inferior iliac spine (AIIS). To confirm location,we will scan along the inguinal
ligament to identify the femoral artery.20 ml of inj Ropivacaine 0.5% will be deposited
in this plane.Patient will be followed up for next 24 hours after the block |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade I II III
Patient more than 18 years and less than 80 years
Patient’s written and informedconsent |
|
| ExclusionCriteria |
| Details |
Uncontrolled hypertension
Uncontrolled diabetes
Patient allergic to study drug
Neurological deficit patient
Deranged coagulation profile |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Ease of Positioning for spinal anaesthesia |
30 minutes after usg guided block |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| post operative pain monitoring |
2,4,6,8,12 and 24 hours |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
N/A |
|
Date of First Enrollment (India)
|
16/04/2023 |
| 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
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is for the patients with hip fractures to provide ease of spinal positioning pre-operatively using the pericapsular nerve group block vs suprainguinal fascia iliaca block and the dosage of rescue analgesia.This diffusion block could also provide postoperative analgesia with the advantage of sparing motor function of quadriceps. |