| CTRI Number |
CTRI/2025/12/099608 [Registered on: 22/12/2025] Trial Registered Prospectively |
| Last Modified On: |
20/12/2025 |
| Post Graduate Thesis |
|
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Surgical/Anesthesia Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of Ultrasound-Guided Femoral and Pericapsular Nerve Block Techniques for Pain Relief After Hip Fracture Surgery |
|
Scientific Title of Study
|
Comparing the efficacy of ultrasound guided combined lateral femoral cutaneous nerve block and femoral nerve block with pericapsular nerve block for post operative analgesia in patients undergoing hip fracture surgeries using levobupivacaine:A prospective randomized study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrJasni K B |
| Designation |
junior resident |
| Affiliation |
Rajarajeswari medical college and hospital |
| Address |
Rajarajeswari medical college and hospital kengeri satellite town kambipura
Bangalore
Bangalore KARNATAKA 560074 India |
| Phone |
9538808087 |
| Fax |
|
| Email |
jasnibasheer97@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DrKarthik G S |
| Designation |
professor and HOD of department of Anaesthesiology |
| Affiliation |
Rajarajeswari medical college and hospital |
| Address |
Rajarajeswari medical college and hospital kengeri satellite town kambipura
Bangalore
Bangalore KARNATAKA 560074 India |
| Phone |
9538220515 |
| Fax |
|
| Email |
drgskarthik@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
DrKarthik G S |
| Designation |
professor and HOD of department of Anaesthesiology |
| Affiliation |
Rajarajeswari medical college and hospital |
| Address |
Rajarajeswari medical college and hospital kengeri satellite town kambipura
Bangalore
KARNATAKA 560074 India |
| Phone |
9538220515 |
| Fax |
|
| Email |
drgskarthik@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesiology, 2nd floor , rajarajeswari medical college and hospital , bangalore-560074 |
|
|
Primary Sponsor
|
| Name |
Dr.Jasni K B |
| Address |
Rajarajeswari medical college and hospital, mysore road, kambipura, bangalore, karnataka-560074 |
| 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 |
| DrJasni K B |
Rajarajeswari medical college and hospital |
Department of Anaesthesiology, Rajarajeswari medical college
and hospital , mysore road, kambipura, bangalore, karnataka -
560074 Bangalore KARNATAKA |
9538808087
jasnibasheer97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S328||Fracture of other parts of pelvis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Femoral nerve block with lateral cutaneous nerve block |
With a linear probe, femoral nerve block will be performed at the inguinal crease level and lateral cutaneous nerve block inferior to anterior superior iliac spine. The probe will be placed below the inguinal ligament identifying the femoral vessels and nerves. Using 23G quincke babcock spinal needle, 20ml of the drug solution will be injected along the nerve sheath. Then the probe is positioned caudal to anterior superior iliac spine to visualise lateral femoral cutaneous nerve between sartorius muscle and tensor fascia lata and 5 ml of drug mixture is injected (5 mins) |
| Comparator Agent |
Pericapsular nerve block with lateral cutaneous nerve block |
With a high frequency probe, which is placed in the transverse plane over the anterior inferior iliac spine moving inferiorly to visualise the pubic ramus using an in plane technique, the 23G quincke babcock spinal needle, 20 ml of drug volume will be deposited between the psoas tendon and superior pubic ramus. Lateral femoral cutaneous nerve block will be performed. (5 mins) |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 and 2 patients with valid informed consent undergoing elective hip fracture surgeries |
|
| ExclusionCriteria |
| Details |
Patient refusal
Patients with coagulopathy
Patients with history of allergy to local anaesthetics
Patients with severe cardiopulmonary disease
Patients on chronic analgesic therapy
Patients with peripheral neuropathy |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Duration of postoperative analgesia
|
Duration of postoperative analgesia
At 0 min, 5th min, 15th min, 30th min, 1st hour, 2nd hour, 6th hour, 10th hour, 14th hour, 18th hour, 24th hour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Hemodynamic parameters
Total analgesia requirement
VAS score on passive leg raise
Any complications |
Both groups will be compared after the blocks given at 0 min, 5 min, 15 min, 30 min, 1 hour, 2 hours, 6 hours, 10 hours, 14 hours, 18 hours, 24 hours |
|
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
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)
|
01/01/2026 |
| 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 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
|
Geriatric patients undergoing hip surgery often experience severe pain after the surgery especially in the early post operative period which can lead to respiratory and cardiac complications, prolonged hospital stays and impaired mobility which ultimately results in poor postoperative outcomes. The pericapsular nerve group (PENG) block is a novel block for hip surgery and pain management in hip fractures that is slowly gaining popularity. This technique blocks all three nerves that innervate the anterior aspect of the hip with a single injection. This block yields excellent pain control with an extremely low incidence of motor block. This approach is unable to manage the pain from the surgical incision since it spares the lateral femoral cutaneous nerve (LFCN).
The combination of PENG plus LFCN block is a relatively new approach with only a small number of case series and case reports available in the literature. Facia iliaca compartment block (FICB) may cause motor weakness, hindering early mobilization. PENG block, a novel technique, targets articular branches of key nerves, offering effective pain relief without significant motor impairment. The addition of lateral cutaneous nerve of thigh block to PENG block may further enhance analgesia.
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