| CTRI Number |
CTRI/2026/01/100912 [Registered on: 12/01/2026] Trial Registered Prospectively |
| Last Modified On: |
12/01/2026 |
| Post Graduate Thesis |
No |
| 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 types of ultrasound-guided nerve blocks for postoperative pain relief — one given near the back muscles (erector spinae plane block) and the other near the hip (fascia iliaca block) — to see which works better in controlling pain after femur fracture surgery |
|
Scientific Title of Study
|
Ultrasound guided erector spinae plane block vs fascia iliaca compartment block for post-operative analgesia in patients undergoing surgery for femur fractures: A Randomised Clinical 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 Neha Chajgotra |
| Designation |
Senior Resident, Department of Anaesthesiology |
| Affiliation |
GMC Kathua |
| Address |
Department of Anaesthesiology and critical care GMC Kathua, Kathua, Jammu and Kashmir, India
Kathua
JAMMU & KASHMIR
184101
India |
| Phone |
7006903323 |
| Fax |
|
| Email |
chajgotraneha55@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajesh Angral |
| Designation |
Associate Professor, Department of Anaesthesiology |
| Affiliation |
GMC Kathua |
| Address |
Department of Anaesthesiology and critical care GMC Kathua, Kathua, Jammu and Kashmir, India
Kathua
JAMMU & KASHMIR
184101
India |
| Phone |
7006047500 |
| Fax |
|
| Email |
rajeshangral73@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajesh Angral |
| Designation |
Associate Professor, Department of Anaesthesiology |
| Affiliation |
GMC Kathua |
| Address |
Department of Anaesthesiology and critical care GMC Kathua, Kathua, Jammu and Kashmir, India
Kathua
JAMMU & KASHMIR
184101
India |
| Phone |
7006047500 |
| Fax |
|
| Email |
rajeshangral73@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Medical College Kathua, district kathua, Jammu and kasmir, India pin: 184101 |
|
|
Primary Sponsor
|
| Name |
Dr Neha Chajgotra |
| Address |
Senior Resident, Department of Anesthesia and critical care GMC Kathua, district Kathua, Jammu and Lashmir, India pin 184102 |
| Type of Sponsor |
Other [Self] |
|
|
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 Rajesh Angral |
Hospital, Government Medical College Kathua |
Department of Anaesthesiology and
critical care, GMC Kathua, district
Kathua, Jammu and Kashmir, India
Kathua
JAMMU & KASHMIR |
07006047500
rajeshangral73@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Govt. Medical College Kathua |
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 |
Erector spinal plane block (ESP) and fascia iliaca compartment block ( FIC) |
Usg guided ESP block , inter fascia plane block given in paraspinal area in which needle placement is between erector spinae muscle and the transverse process of vertebra and usg guided FIC given near the hip, under the fascia iliaca layer superficial to the iliac us muscle. |
| Comparator Agent |
Usg guided ESP block versus FIC block |
The ESP group will receive 30 mL of total drug ( 28 mL of injection ropivacaine 0.25% + 6 mg of adenosine (2ml)) and FICB group will receive the same composition of the drug. Here two techniques will be compared. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1) patients between age group of 18 years to 80 years who are undergoing femur fracture fixation
2) ASA class 1 -3
3) patients who are willing to participate and provide a willing written informed consent |
|
| ExclusionCriteria |
| Details |
1) patients with any chronic medical illness
2) history of any bleeding disorders
3) patients allergic to any of these drugs
4) history of chronic opioid use
5) history of cognitive impairment
6) local infection at site |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) Severity of pain using Visual Analog Scale ( VAS)
2) Time to 1st request of analgesia |
Severity of pain using VAS at
1,2,6,12 and 24 hours after surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Total number of analgesic doses of opioids and NSAIDS in 24 hours following
surgery
2) side effects like nausea, vomiting and shivering |
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)
|
01/02/2026 |
| 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
|
This study is a randomised, parallel group, clinical trial comparing the effectiveness of two blocks
i.e ultrasound guided Erector Spinae plane block versus fascia iliaca compartment block for
postoperative analgesia in patients undergoing femur fracture surgeries, as measured by duration of
analgesia and pain score in 24 hours following surgery. The primary outcome of the study is to
record the severity of pain using visual analog scale and time to request of first analgesia i.e
the time elapsed between the end of surgery to 1st dose of analgesia. The secondary outcome is
to see the total no. of analgesic doses of opioids and NSAIDs in 24 hours following surgery and to
see any side effects like nausea, vomiting and shivering occurring after the procedure
|