| CTRI Number |
CTRI/2025/09/095030 [Registered on: 18/09/2025] Trial Registered Prospectively |
| Last Modified On: |
18/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study comparing two ultrasound assisted nerve block techniques for pain relief in adults with hip fractures |
|
Scientific Title of Study
|
Efficacy Of ultrasound -guided Pericapsular nerve group (PENG) Block vs Iliopsoas plane block in pain relief in the adult Patients with Hip fractures attending to the Emergency Department; A Double-blinded Randomized controlled trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Joshwa ajay J |
| Designation |
PG student |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research(JIPMER) |
| Address |
Room No 5, First floor, Emergency Medicine Department, ED division, EMSD building, Dhanvantri nagar, JIPMER
Pondicherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9787536889 |
| Fax |
|
| Email |
joshwaajay321@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manu Ayyan |
| Designation |
Associate Professor |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research(JIPMER) |
| Address |
No 7, Emergency Medicine division, First Floor EMSD Building,
Jawaharlal Institute of Postgraduate Medical Education and
Research DHANVANTRI NAGAR
Pondicherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9846556133 |
| Fax |
|
| Email |
manuayyan@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manu Ayyan |
| Designation |
Associate Professor |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research(JIPMER) |
| Address |
No 7, Emergency Medicine division, First Floor EMSD Building,
Jawaharlal Institute of Postgraduate Medical Education and
Research DHANVANTRI NAGAR
Pondicherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9846556133 |
| Fax |
|
| Email |
manuayyan@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Institute of Postgraduate Medical Education and Research, Dhanvantri Nagar,
Puducherry. 605006 India
|
|
|
Primary Sponsor
|
| Name |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Jawaharlal Institute of Postgraduate Medical Education and Research
DHANVANTRI NAGAR PUDUCHERRY 605006
India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 JOSHWA AJAY J |
Jawaharlal Institute of Postgraduate Medical Education and Research |
No-3, Research
Division, Emergency
Medicine Department,
First Floor EMSD
Building
Pondicherry
Pondicherry
PONDICHERRY |
9787536889
joshwaajay321@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE INTERVENTIONAL STUDIES JIPMER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: S720||Fracture of head and neck of femur, (3) ICD-10 Condition: S722||Subtrochanteric fracture of femur, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ultrasound guided Iliopsoas Plane Block |
The Hip fracture patients will receive ultrasound guided Iliopsoas Plane Block .Probe is placed in the transverse plane distal to the anterior superior iliac spine (ASIS) and then the probe was rotated about 30 degree in counter clockwise on right side and clockwise in left side, and parallel shifted along inguinal ligament until hip joint is identified where the head of femur enters the acetabular rim.The needle was penetrated through the sartorius and reached into iliopsoas plane final needle tip is placed between the iliopsoas muscle and iliofemoral ligament lateral to Iliopsoas tendon.Then 0.5% Bupivacaine (2.5mg/kg of bupivacaine with maximum of 150mg) diluted in normal saline to a total volume of 10 ml will be injected.
|
| Intervention |
Ultrasound guided Pericapsular nerve group (PENG) Block |
The Hip fracture patients will receive ultrasound guided PENG block.Probe is aligned along inguinal ligament and anterior inferior iliac spine (AIIS) identified probe moved infero medially and pubic eminence identifed.The needle will be advanced infero-medially to contact the pubic rami.Then 0.5% Bupivacaine (2.5mg/kg of bupivacaine with maximum of 150mg) diluted in normal saline to a total volume of 25 ml will be injected.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All adult patients more than 18 years of age with hip fractures
1 Head of femur fractures
2 Neck of femur fractures
3 Intertrochanteric fractures
4 Sub trochanter fractures
5 Acetabular fractures
And NRS score of greater than 4 at the site of hip injury |
|
| ExclusionCriteria |
| Details |
1 Known allergy to amide-type local anaesthetics , NSAIDS,Tramadol and fentanyl.
2 Pregnancy
3 Institutionalized individuals and prisoners
4 Unable to give consent due to dementia or altered mental status
5 Requiring immediate surgical intervention
6 Patents with suspected vascular injury in ipsilateral limb
7 Signs of infection or laceration at the injection site
8 The patient had undergone surgery on the same hip prior to thisfracture
9 History of chronic pain, chronic use of analgesics
10 History of substance abuse
11 Bilateral hip injuries
12 History of any bleeding diathesis
13 Patient has been transferred from the inpatient facility of anotherhospital after the surgical repair of a hip fracture.
14 hip dislocation
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of USG-guided Iliopsoas plane block (IPB) with USG-guided pericapsular nerve block (PENG) in reducing pain,in adult patients with hip fractures presenting to the Emergency department. |
30 minutes 1 Hour 2 hours 3 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the total amount of rescue analgesia requirements between ultrasound-guided Iliopsoas plane block (IPB) and ultrasound -guided Pericapsular nerve group (PENG) block in Patients with Hip fractures presenting to the Emergency department. |
3 hours |
To assess the complications of USG-guided Iliopsoas plane block and compare it with complications of PENG blocks within patients with Hip fractures presenting to the Emergency Department.
|
3 hours |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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)
|
02/10/2025 |
| 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="6"
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
|
Hip fractures are frequently encountered in patients who present to the Emergency department following road traffic accidents, Self fall and other modalities of trauma. It is associated with high morbidity, in terms of pain encountered by patients and mortality. Compounded by a wide array of complications associated with Hip fractures such as severe excruciating pain, hypovolemic shock, vascular and nerve injuries makes their treatment challenging.In the emergency department, apart from the initial pain reported by patients due to the injury, these patients will undergo further traction and movements of the fractured segment, which further exacerbate the pain. This has been overcome with intravenous analgesia and regional analgesia like ultrasound -guided pericapsular nerve block (PENG) but these causes adverse effect like quadriceps weakness and higher level of analgesics but recently motor sparing ultrasound -guided Iliopsoas plane block (IPB) a novel method for hip analgesia whose efficacy is not well established yet . The aim of this study is to see the effect of the Iliopsoas plane block in the control of the hip fracture pain as well as to compare the effectiveness of the IPB compared to PENG. Although studies have utilized Iliopsoas plane block for analgesia in reliving post operative pain in hip fracture or post hip arthroplasty, the efficacy and safety of the same and the feasibility of performing it in an emergency setup in patients with Hip fractures and comparison study with pericapsular nerve block is yet to be evaluated as a randomized controlled trial, to the best of our knowledge. Furthermore, once established, the routine usage of it in Hip fracture patients as a part of a multimodal approach to lessen pain without increasing the complications of multiple intravenous analgesics. |