CTRI Number |
CTRI/2025/05/086994 [Registered on: 15/05/2025] Trial Registered Prospectively |
Last Modified On: |
28/04/2025 |
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
|
Comparison of pericapsular nerve group block and fascia iliaca compartment block for analgesia after hip fracture surgery |
Scientific Title of Study
|
A randomized comparative study to evaluate pre operative and post operative analgesic effect of ultrasound guided pericapsular nerve group block Vs fascia iliaca block in patients undergoing elective hip fracture surgery in Department of Anaesthesiology, SMS Medical College and Attached Hospitals, Jaipur |
Trial Acronym |
NIL |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Mohamed Eshan P |
Designation |
MD 3rd year |
Affiliation |
SMS MEDICAL COLLEGE,JAIPUR |
Address |
department of anaesthesia,2nd floor, Dhanwantari building, SMS medical college, Jaipur
Rajastan
302004
INDIA
Jaipur RAJASTHAN 302004 India |
Phone |
9072751125 |
Fax |
|
Email |
ESHANICHU50@GMAIL.COM |
|
Details of Contact Person Scientific Query
|
Name |
Mamta Khandelwal |
Designation |
Senior Professor |
Affiliation |
SMS medical college, Jaipur |
Address |
department of anaesthesia 2nd floor Dhanwantari building SMS
medical college Jaipur
Jaipur
RAJASTHAN
302004
India
Jaipur RAJASTHAN 302004 India |
Phone |
9929338174 |
Fax |
|
Email |
drmamtakhandelwal@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Mamta Khandelwal |
Designation |
Senior Professor |
Affiliation |
SMS medical college, Jaipur |
Address |
department of anaesthesia 2nd floor Dhanwantari building SMS
medical college Jaipur
Jaipur
RAJASTHAN
302004
India
Jaipur RAJASTHAN 302004 India |
Phone |
9929338174 |
Fax |
|
Email |
drmamtakhandelwal@gmail.com |
|
Source of Monetary or Material Support
|
|
Primary Sponsor
|
Name |
SMS medical college, Jaipur |
Address |
department of anaesthesia 2nd floor dhanwantari building sms
medical college jaipur |
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 Mamta Khandelwal |
SMS medical college |
Department of
Anaesthesia, Second
Floor, Dhanwantri OPD
Block, SMS Medical
College
Jaipur
RAJASTHAN Jaipur RAJASTHAN |
9929338174
drmamtakhandelwal@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
office of ethic comittee sms medical college and attached hospital, jaipur |
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 |
Comparator Agent |
USG guided FASCIA ILIACA COMPARTMENT block in 30 patients |
Patients will receive ultrasound guided Pericapsular Nerve
Group Block with 20ml of 0.4% Ropivacaine (11.0mL of
0.75% Ropivacaine + 9 mL of Normal Saline). NRS score
will be assessed at an interval of 1 minute, up to 20 minutes
until NRS less than 3. This time will be noted. In the
postoperative period, the analgesic efficacy will be assessed
at various intervals for 24 hours. |
Intervention |
USG guided PENG block in 30 patients |
Patients will receive ultrasound guided pericapsular nerve group block
with 20 ml of 0.4% Ropivacaine(11.0mL of 0.75%
Ropivacaine + 9mL of Normal Saline). NRS score will be
assessed at an interval of 1 minute, up to 20 minutes until
NRS less than 3. This time will be noted. In the
postoperative period, the analgesic efficacy will be assessed
at various intervals for 24 hours. |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
64.00 Year(s) |
Gender |
Both |
Details |
1. Patients undergoing elective surgery for hip fracture.
2. Patient having baseline NRS more than 7
3. Patients consenting to participate.
4. Adult patients.
5 Patients belonging to American Society of Anesthesiologists (ASA) grade I,
II and III. |
|
ExclusionCriteria |
Details |
1.Patients with psychiatric illness, anxious, agitated.
2.Patients with peripheral sensorineural deficit.
3.Patients allergic to local anesthetics.
4.Patients with contraindications to regional anaesthesia.
5. Patients with suspected compartment syndrome in lower limbs.
6.Patients on analgesia within 8 hours before performing nerve block.
7. Block failure cases -If NRS score is not less than 3 within 20 min of performing
peripheral nerve block. |
|
Method of Generating Random Sequence
|
Random Number Table |
Method of Concealment
|
On-site computer system |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
1.To assess and compare pain by NRS at
different time intervals after administration of block.
2.To observe the change in NRS at one
minute interval maximum up to 20 minutes
after administration of block, until NRS less
than 3 for positioning of patient for spinal
anaesthesia.
3.To determine the difference in mean time
of first rescue analgesia by using NRS and
mean dose of analgesic required in 24 hours
in both groups.
|
1.To assess and compare pain by
NRS at 30min,1st,2nd,4th and 6th hr followed by every 6th hourly till 24 hours after administering block.
2.To observe the change in NRS at
one minute interval up to 20 minutes
after administration of block, for
positioning of patient for spinal
anaesthesia.
3.To determine the mean dose of
analgesic required in 24 hours in
both groups. |
|
Secondary Outcome
|
Outcome |
TimePoints |
To determine the change in the hemodynamic parameters (HR, SBP, DBP, MAP and
SpO2) in both groups.
|
at 30 min,1,2,4,6 hour and 6 hourly afterwards till 24 hours after block |
2. To assess and compare patient satisfaction by using three point likert rating scale
between both the groups |
at 30 min,1,2,4,6 hour and 6 hourly afterwards till 24 hours after block |
To observe side effect or complication, if any |
in pre-operative,peri-operative and post-operative period |
|
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
|
Phase 2 |
Date of First Enrollment (India)
|
20/05/2025 |
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="0" Months="5" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
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 considered as a widespread problem on a global scale and significant public health issue in numerous nations. On a worldwide scale, hip fractures are listed as one of the top 10 causes of disability. Hip fractures frequently occur as urgent orthoedic incidents in the elderly population,and they are linked to notably high rates of morbidity and mortality.In most cases,surgical reduction and fixation represent definitive treatment approach. Irrespective of the type of surgical procedure, hip surgeries cause significant postoperative pain which can result in further complications and patient dissatisfaction. Indeed, the need for optimal analgesia cannot be underestimated for hip surgeries wherein the patient clientele is mostly elderly and the joint is primarily involved in patient mobility. The 2011 NICE guidelines for management of hip fractures recommend the use of IV paracetamol, opioids, and peripheral nerve blocks . Oral or intravenous analgesics, particularly opioids can cause unwarranted sedation, nausea, vomiting, respiratory depression, and delirium. The elderly population have a significant risk of delirium due to their age, co-morbidities, altered metabolic functions and physiology, or due to the under or over treatment of pain Regional anesthetic techniques are increasingly being used to provide better pain control. Peripheral nerve blocks have several advantages such as, adequate pain management in the pre-operative and post-operative time, facilitate early mobilization, and reduction in the dose of opioids required and their related side effects . The femoral nerve block block and the fascia iliaca compartment block (FICB) are commonly used analgesic techniques in hip surgeries. Both blocks have equivalent analgesic efficacy. However, a disadvantage of the fascia iliaca block is the associated motor weakness of the surgical limb which can delay recovery and patient discharge The hip joint is innervated by branches of the obturator nerve, anterior obturator nerve, and the femoral nerve. Studies suggest that the anterior capsule of the hip joint is richly innervated by these nerves and is targeted to provide analgesia. Recently, GirĂ³n-Arango (9), have described a novel anaesthetic modality named the pericapsular nerve group (PENG) block which anesthetizes the femoral nerve, obturator nerve, and the accessory obturator nerve while sparing the motor components. Studies have shown that the PENG block is efficient in providing postoperative analgesia in patients undergoing hip surgeries with preservation of quadriceps muscle strength Ultrasound guidance improves visualization of anatomical structures, success rate, quality of sensory block, onset time, decreases dose of local anesthetics and complications. There are very few studies that compare the efficacy of PENG vs FIB for postoperative analgesia in patients who underwent surgery for hip fracture. In this study we aim to compare the preoperative and postoperative analgesic efficacy of ultrasound guided Pericapsular Nerve Group Block vs Fascia iliaca Block In Patients Undergoing Hip Fracture Surgery |