FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/05/086515 [Registered on: 07/05/2025] Trial Registered Prospectively
Last Modified On: 06/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Other 
Public Title of Study   Comparision of two nerve group blocks to study better pain relief during positioning of patients. 
Scientific Title of Study   Analgesic Efficacy of Ultrasound guided pericapsular nerve group block versus fascia iliaca compartment block for positioning pain during spinal anaesthesia in hip fractures - A Randomised comparitive 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  Aravindhan V  
Designation  Junior Resident 
Affiliation  Mahatma Gandhi Memorial Medical College 
Address  Department of Anaesthesiology ,M.Y Hospital and Mahatma Gandhi Memorial Medical College,Indore,Madhya Pradesh

Indore
MADHYA PRADESH
452001
India 
Phone  9524154441  
Fax    
Email  aravindvelzgt@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR Deepali Valecha 
Designation  Assistant Professor 
Affiliation  Mahatma Gandhi Memorial Medical College 
Address  Mahatma Gandhi Memorial Medical College and M.Y hospital, Indore, Madhya Pradesh pin code 452001

Indore
MADHYA PRADESH
452001
India 
Phone  9424405404  
Fax    
Email  deepalisidhwani@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR Deepali Valecha 
Designation  Assistant Professor 
Affiliation  Mahatma Gandhi Memorial Medical College 
Address  Department of Anaesthesiology ,Mahatma Gandhi Memorial Medical college and M.Y Hospital Indore Madhya Pradesh pin code 452001

Indore
MADHYA PRADESH
452001
India 
Phone  9424405404  
Fax    
Email  deepalisidhwani@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology ,M.Y Hospital and Mahatma Gandhi Memorial Medical College ,Indore ,Madhya Pradesh , India pin code 452001. 
 
Primary Sponsor  
Name  Mahatma Gandhi Memorial Medical college and MYHospital 
Address  Department of Anaesthesiology ,Mahatma Gandhi Memorial Medical College and M.Y Hospital Indore Madhya Pradesh India pin code 452001. 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR ARAVINDHAN V  Mahatma Gandhi Memorial Medical College and M.Y.Hospital, Indore, Madhya Pradesh  Ground Floor , Operation theatre complex ,Department of Anaesthesiology office, MY Hospital ,Indore, Madhya Pradesh, India pincode 452001.
Indore
MADHYA PRADESH 
9524154441

aravindvelzgt@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ETHICS AND SCIENTIFIC REVIEW COMMITTEE, M.G.M MEDICAL COLLEGE, M.Y HOSPITAL ,INDORE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S729||Unspecified fracture of femur,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Fascia iliaca nerve group block  patients of one group will receive fascia iliaca compartment block ultrasound guided with 20ml of 0.25% bupivacaine and will be monitored for 15 minutes after giving block. 
Intervention  Pericapsular nerve group block  patients of one group will receive pericapsular nerve group block ultrasound guided with 20ml of 0.25% Bupivacaine and will be monitored for 15 minutes after giving block. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  ASA Physical status score of I,II,III, Hip fracture patients taken for elective surgery 
 
ExclusionCriteria 
Details  Patient refusal for consent, patients with bleeding diathesis, skin pathology at injection site, patients with known allergy to study drugs, patients with neurological and psychiatric illness 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To compare the analgesic efficacy of the ultrasound guided pericapsular nerve group block with fascia iliaca compartment block for positioning pain during spinal anaesthesia in hip fracture patients in terms of
1.Visual Analogue scale score
2.Ease of spinal positioning using ease of positioning scale 
A 10 point Visual Analogue Score (VAS) will be recorded before and immediately after the intervention at 0mins immediately after block followed by 2minutes ,5 minutes ,10 minutes and 15 minutes 
 
Secondary Outcome  
Outcome  TimePoints 
To observe hemodynamic changes in the period from time of nerve block to positioning for spinal anaesthesia  Hemodynamic parameters such as heart rate, Mean arterial pressure, oxygen saturation will be recorded at baseline 0 minutes after intervention also at 2 minutes, 5 minutes, 10 minutes, 15 minutes. 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   17/05/2025 
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="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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) - 

  6. For how long will this data be available start date provided 01-05-2025 and end date provided 01-05-2025?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

INTRODUCTION 

Hip fractures are associated with severe morbidity and mortality. These fractures require early surgical fixation and subarachnoid block is preferred as mode of anaesthesia. But, severe pain during positioning may complicate the procedure of subarachnoid block. Nerve blocks such as femoral nerve block, peri capsular nerve group block, fascia iliaca compartment block can help us in reducing positional pain. Ultrasound guidance has shown to increase the precision and effectiveness of these blocks. Therefore this study aims to compare the efficacy between usg guided pericapsular nerve group block and fascia iliaca compartment block for positioning of patients of hip fractures for subarachnoid block. 

 METHODOLOGY

After receiving approval from the Institutional Ethical Committee of M.G.M Medical College, 100 ASA grade 1,2 and 3 patients posted for elective surgery will be included in the study. Patients will be explained about the procedure and due risks involved in their own language and informed consent will be taken. On the day of surgery, patients will be allocated either of the two groups group PENG and FICB.  As soon as patient enter the operation theatre, intravenous access will be obtained and preloading with Ringer lactate at the rate of10ml/kg will be started. Baseline Vital parameters will be noted. Group PENG Ultrasound guided pericapsular nerve group block will be given by using 20 ml of 0.25% bupivacaine.  Group FICB Ultrasound guided fascia iliaca compartment block will be given by using 20 mL of 0.25% bupivacaine. A 10 point Visual Analogue Score VAS will be recorded before and immediately after the intervention at 0,2, 5, 10 and 15 minutes. Patients with VAS score 3 or less than 3 after 15 minutes will be positioned sitting position for subarachnoid block and Ease of spinal positioning will be assessed according to the scale.  Ease of positioning scale EOP scale 0– Unable to position 1- Patient with abnormal position due to pain or required support for position 2- Mild discomfort but does not require support for position 3- Optimal position. Patient with EOSP more or equal to 2 will be considered as acceptable position. Patients with VAS score more than 3 even after 15 minutes will be provided additional analgesia i.e injection paracetamol 15 mg/kg to alleviate Pain and will be excluded from the study. Hemodynamic parameters such as Heart rate, Mean arterial pressure, oxygen saturation will be recorded at baseline, after intervention at 2min, 5 min, 10 min, 15 min. Adverse effects like nausea, vomiting,bradycardia, hypotension, abscess formation, hematoma allergic reactions, local Anaesthetic systemic toxicity or any other if present will be noted and managed by standard medical protocol.

REFERENCES:

 1. Acharya U, Lamsal R. Pericapsular Nerve Group Block: An Excellent Option for Analgesia for Positional Pain in Hip Fractures. Case Rep Anesthesiol. 2020 Mar 12;2020:1830136. doi: 10.1155/2020/1830136. PMID: 32231802; PMCID: PMC7091518. 

2. Dr. Amarnath Naik Korra, Dr. Rajendra Kiran Brahmaroutu, Dr. AS Kameswara Rao. Comparative evaluation between fascia iliaca compartment block and intravenous fentanyl administration for painless positioning during spinal Anaesthesia in fracture femur surgeries: A randomized controlled study. Int J Med Anesthesiology 2020;3(1):306-310. DOI: 10.33545/26643766.2020.v3.i1e.106

 3. Kaur G, Saikia P, Dey S, Kashyap N. Pericapsular nerve group (PENG) block—a scoping review. Ain-Shams J Anesthesiol. 2022;14(1):29. doi: 10.1186/s42077-022-00227-0. Epub 2022 Mar 14. PMCID: PMC8919174. 

4. Kalashetty MB, Channappa Gowda R, Alwandikar V, Naik DL, Hulakund SY, Guddad A. Comparison of Pericapsular Nerve Group Block with Fascia Iliaca Compartment Block in Adult Patients Undergoing Hip Surgeries: A Double-Blinded Randomized Control Study. Anesth Essays Res. 2022 Jul-Sep;16(3):397-401. doi: 10.4103/aer.aer_123_22. Epub 2022 Dec 9. PMID: 36620112; PMCID: PMC9813981. 

5. Griffiths R, Alper J, Beckingsale A, Goldhill D, Heyburn G, Holloway J, et al. Management of proximal femoral fractures 2011. Anaesthesia . 2012 Jan;67(1):85–98. Available from: http://doi.wiley.com/10.1111/j.1365- 2044.2011.06957.x 

6. Van Waesberghe J, Stevanovic A, Rossaint R, et al. General vs. neuraxial anaesthesia in hip fracture patients: a systematic review and meta-analysis. BMC Anesthesiol. 2017;17. DOI:10.1186/s12871-017-0380-9. 

7. Madabushi,Rajappa,ThammannaPP,etal.Fascia iliaca block vs intravenous fentanyl as an analgesic technique before positioning for spinal anesthesia in patients undergoing surgery for femur fractures—a randomized trial. J Clin Anesth. 2016;35:398–403. 

8. Girón-Arango L, Peng PWH, Chin KJ, et al. Pericapsular nerve group (PENG) block for hip fracture. Reg Anesth Pain Med. 2018;43:1. 

9. Kumar A, Sinha C, Kumar A, et al. Positioning of fracture femur patients for spinal anaesthesia: femoral nerve block or intravenous fentanyl? Bali J Anesthesiol. 2018;2:61. 

10. Sia S, Pelusio F, Barbagli R, et al. Analgesia before performing a spinal block in the sitting position in patients with femoral shaft fracture: a comparison between femoral nerve block and intravenous fentanyl. Anesth Analg. 2004;99:1221–1224.

 

 
Close