| CTRI Number |
CTRI/2025/06/088036 [Registered on: 02/06/2025] Trial Registered Prospectively |
| Last Modified On: |
20/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of Ultrasound guided pericapsular nerve group
vs iliopsoas plane block |
|
Scientific Title of Study
|
Comparison of efficacy of ultrasound guided pericapsular nerve group (PENG) vs iliopsoas plane block (IPB) for facilitating positioning for central neuraxial block in patients for proximal hip surgeries: a prospective observational 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 |
Mude Nanda Kumar Naik |
| Designation |
Resident doctor |
| Affiliation |
Lokmanya Tilak Municipal General Hospital |
| Address |
Department of Anaesthesia,Lokmanya tilak municipal medical
college and Lokmanya tilak municipal general hospital ,Sion, Mumbai
Mumbai
MAHARASHTRA
400022
India
Mumbai
MAHARASHTRA
400022
India |
| Phone |
7330617080 |
| Fax |
|
| Email |
nandhumydad123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shruti Patil |
| Designation |
Associate Professor |
| Affiliation |
Lokmanya Tilak Municipal General Hospital |
| Address |
Department of Anaesthesia,Lokmanya tilak municipal medical
college and Lokmanya tilak municipal general hospital ,Sion, Mumbai
Mumbai
MAHARASHTRA
400022
India
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9619153353 |
| Fax |
|
| Email |
dr.shrutipatil@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shruti Patil |
| Designation |
Associate Professor |
| Affiliation |
Lokmanya Tilak Municipal General Hospital |
| Address |
Department of Anaesthesia,Lokmanya tilak municipal medical
college and Lokmanya tilak municipal general hospital ,Sion, Mumbai
Mumbai
MAHARASHTRA
400022
India
MAHARASHTRA
400022
India |
| Phone |
9619153353 |
| Fax |
|
| Email |
dr.shrutipatil@gmail.com |
|
|
Source of Monetary or Material Support
|
| Lokmanya tilak municipal medical college and Lokmanya tilak municipal general hospital ,Sion,
Mumbai, INDIA 400022 |
|
|
Primary Sponsor
|
| Name |
Mude Nanda Kumar Naik |
| Address |
Department of Anaesthesia, LTMMC and LTMGH Sion |
| Type of Sponsor |
Other [other (self) ] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Shruti Patil |
Department of Anaesthesia, LTMMC and LTMGH Sion |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mude Nanda Kumar Naik |
Lokmanya tilak medical college |
Orthopaedic operation theatre,3 rd floor, Ward building, Lokmanya tilak medical college,Sion Mumbai
Mumbai
MAHARASHTRA |
7330617080
nandhumydad123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Human Research Lokmanya tilak medical college & general hospital |
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 |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Patients scheduled for hip surgery under central neuraxial block |
|
| ExclusionCriteria |
| Details |
1)Contraindications for spinal anaesthesia, PENG block and Iliopsoas plane block
2)Patient with multiple fractures
3)Refusal to participate
4)Local infection
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Haemodynamic parameters
and VAS will be observed every minute in first 5 minutes and every 5 minutes for next 30
minutes. |
every minute in first 5 minutes and every 5 minutes for next 30 min
minutes. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| VAS (Visual Analogue scale) during sitting position |
at 30 min |
VAS during supine position
I. Static
ii. Dynamic (Passive leg raising 15°) at 5,10,15,30 min
iii. VAS (Visual Analogue scale) during sitting position
iv. Quadriceps strength using MMT scale [0-5], where 0 is no muscle contraction and
5 can bear full resistance.
|
at 5,10,15,30 min |
| Quality of patient positioning will be assessed by the anaesthetist giving spinal anaesthesia |
at 30 min |
| patient satisfaction score in sitting position using a three point likert scale |
at 30 min |
| block administration time from ultrasound scanning to completion of drug injection |
at 0 min |
| number of needle passes required [number of needle redirection] |
at 0 min |
| ease of performance of block [ easy, moderate, difficult] |
at 0 min |
Requirement of supplemental IV analgesic agents for positioning
Additional analgesia in the form of injection paracetamol 1gm IV, injection
fentanyl (1-2 mcg/ kg) IV, injection tramadol (2 mg/kg) IV will be noted.
The time, dose and drug details will be noted for giving position for central
neuraxial block |
at 30 min |
| Sensory anaesthesia over anterior aspect of thigh using ether swab |
at 30 min |
Complications if any (bleeding / haematoma formation, neuropathy and systemic toxicity).
Thereafter Spinal /CSE will be administered as per routine protocol. |
at 30 min |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
15/06/2025 |
| 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="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
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
|
this prospective observational study will be conducted at orthopaedic operation theatre and emergency trauma operation theatres of LTMMC Sion in patients posted for hip surgery between the period of 2024-2025. A thorough preanaesthetic evaluation will be done. After obtaining written and informed consent from each subject, data such as sex, age, as well as type of fracture will be collected. The subjects fulfilling the inclusion criteria will be included in the study. Routine protocol is as follows: Standard ASA monitors (non-invasive blood pressure, pulse, oxygen saturation, and electrocardiogram) are applied and supplemental oxygen (nasal cannula at 2 L/ min) is given. Intravenous (I.V) access is secured and I.V Fluid is started. Ultrasound-guided PENG (Pericapsular nerve group)block, IPB(Illiopsoas block), FNB (femoral nerve block) or fascia iliac block or I.V fentanyl are routinely administered for pain relief for facilitating positioning for spinal anaesthesia in patients with hip fractures. Baseline parameters like VAS, Heart rate (HR), Systolic Blood pressure (SBP), Diastolic Blood Pressure (DBP), Saturation (SPO2) will be noted. Patients given PENG block or IPB will be included in the study. Patients receiving PENG block will be included in Group A, and those receiving IPB will be included in Group B. The USG blocks will be administered by a senior anaesthesiologist experienced in regional anaesthesia. After standard skin disinfection the block will be performed with a portable ultrasound machine with curvilinear probe, 2-5 MHz and 100- mm short-bevelled stimulating needle after a short introduction and explanation of the procedure. Technique for PENG block: With patient in supine position, under all aseptic precautions, the low frequency curvilinear ultrasound probe is placed over the line joining anterior superior iliac spine (ASIS) and pubic tubercle (PT) keeping lateral margin at ASIS. The probe is thereafter tilted cranially to visualize the AIIS (Anterior inferior iliac spine), iliopsoas muscle and tendon, Iliopubic eminence, the femoral artery, and the pectineus muscle. After local infiltration (2% lignocaine 2 cc), the needle tip is placed next to the iliopsoas tendon. Drug administered routinely is 20cc 0.375% ropivacaine. Technique for IPB: With patient in supine position, under all aseptic precautions, the low frequency curvilinear ultrasound probe is placed distal to the anterior superior iliac spine in the transverse plane. The probe is then gyrated in an anticlockwise direction on right and clockwise on the left, about 30° and slid along the inguinal ligament until the head of the femur is seen enter the acetabular rim. After a local infiltration (2% lidocaine 2cc), a needle tip reaches the plane between the iliopsoas muscle and the iliofemoral ligament . Drug administered routinely is, 10 ml of 0.375% ropivacaine. Thereafter the following parameters would be monitored and compared between USG guided PENG block and IPB.Thereafter patient will be made to sit after 30 min of the block and the above parameters will be assessed. Central neuraxial block will be administered as per protocol. PARAMETERS TO BE STUDIED: After administration of blocks, the following parameters for the study purpose will be monitored in both the groups Heart rate, blood pressure, saturation, VAS (Visual analogue scale), onset of analgesia, additional analgesic requirement for positioning will be noted. Haemodynamic parameters and VAS will be observed every minute in first 5 minutes and every 5 minutes for next 30 minutes. Side effects or complications if any will be noted. 1. VAS (Visual Analogue scale) during sitting position 2. VAS during supine position I. Static ii. Dynamic (Passive leg raising 15°) at 5,10,15,30 min iii. VAS (Visual Analogue scale) during sitting position iv. Quadriceps strength using MMT scale [0-5], where 0 is no muscle contraction and 5 can bear full resistance. 3. Quality of patient positioning will be assessed by the anaesthetist giving spinal anaesthesia (0 = not satisfactory, 1 = satisfactory, 2 = good, 3 = optimal). 4. patient satisfaction score in sitting position using a three point likert scale In the event of VAS score more than 5 in sitting position after 30 min, rescue analgesia will be given. The rescue analgesia /technique will be decided by senior anaesthetist in-charge. The same will be noted. 5.block administration time from ultrasound scanning to completion of drug injection 6.number of needle passes required [number of needle redirection] 7.ease of performance of block [ easy, moderate, difficult] 8.Requirement of supplemental IV analgesic agents for positioning Additional analgesia in the form of injection paracetamol 1gm IV, injection fentanyl (1-2 mcg/ kg) IV, injection tramadol (2 mg/kg) IV will be noted. The time, dose and drug details will be noted for giving position for central neuraxial block 9.Sensory anaesthesia over anterior aspect of thigh using ether swab 10.Complications if any (bleeding / haematoma formation, neuropathy and systemic toxicity). Thereafter Spinal /CSE will be administered as per routine protocol. |