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CTRI Number  CTRI/2020/09/027893 [Registered on: 18/09/2020] Trial Registered Prospectively
Last Modified On: 12/09/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing two different techniques in providing pain relief for better positioning of patient while performing injection at the back of spine in patients undergoing hip fracture surgeries 
Scientific Title of Study   A Randomized Control Study To Compare The Efficacy Of Pre-Emptive Ultrasound Guided Fascia Iliaca Compartment Block With Pericapsular Nerve Group Block For Positioning Of Spinal Anaesthesia In Hip Fracture Surgeries 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Parameshwaran M 
Designation  Post Graduate Student 
Affiliation  SRM Medical College Hospital And Research Centre  
Address  Room Number 1606 ANESTHESIA DEPARTMENT SRM Medical College Hospital And Research Centre SRMIST Potheri Kancheepuram

Kancheepuram
TAMIL NADU
603203
India 
Phone  9994613023  
Fax    
Email  daredoparam@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Parameshwaran M 
Designation  Post Graduate Student 
Affiliation  SRM Medical College Hospital And Research Centre  
Address  Room Number 1606 ANESTHESIA DEPARTMENT SRM Medical College Hospital And Research Centre SRMIST Potheri Kancheepuram

Kancheepuram
TAMIL NADU
603203
India 
Phone  9994613023  
Fax    
Email  daredoparam@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Karthik K 
Designation  Associate Professor 
Affiliation  SRM Medical College Hospital And Research Centre  
Address  DEPARTMENT OF ANAESTHESIOLOGY SRM Medical College Hospital And Research Centre SRMIST Potheri Kancheepuram

Kancheepuram
TAMIL NADU
603203
India 
Phone  7904412483  
Fax    
Email  karthikkrishnamoorthy1981@gmail.com  
 
Source of Monetary or Material Support  
SRM Medical College Hospital And Research Centre, SRMIST, Potheri,kattankulathur.kancheepuram District-603203  
 
Primary Sponsor  
Name  SRM Medical College Hospital And Research Centre 
Address  SRMIST SRM Nagar Potheri  
Type of Sponsor  Research institution and hospital 
 
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 Parameshwaran M  SRM Medical College Hospital And Research Centre  Room Number 1606 DEPARTMENT OF ANAESTHESIOLOGY
Kancheepuram
TAMIL NADU 
9994613023

daredoparam@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SRM Medical College Hospital And Research Centre.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 8||Other Procedures,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Fascia Iliaca Compartment Block   30 ml of 0.5% ropivacaine Is Injected Below The Fascia Iliaca Plain Using Ultrasound 
Intervention  Pericapsular Nerve Group Block   20 ml of 0.75% Ropivacaine Is Injected In The Interfacial Plain Aiming To Block Articular Branches Supplied By Femoral Obturator And Accesory Obturator Nerves Using Ultrasound 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  ASA 1 2 3
Patients admitted for elective and emergency hip fracture surgeries under spinal anaesthesia.
 
 
ExclusionCriteria 
Details  patient refusal,
any contra indication for spinal anaesthesia,
infection at the site of block,
allergy to local anaesthetic drugs or other medications used in the study,
coagulopathy.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Comparison of quality of positioning for spinal anaesthesia for hip fracture surgeries  From starting until end of performing spinal anesthesia  
 
Secondary Outcome  
Outcome  TimePoints 
1)To evaluate the duration of post-operative analgesia
2)Requirement of post-operative analgesics for 24 hrs.
 
Till 24 hrs Post Operatively 
 
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   N/A 
Date of First Enrollment (India)   28/09/2020 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Patients who met the inclusion criteria will be randomly allocated into two groups, Group A and Group B with  30 in each group based on computer generated random envelope method. Group F patients will receive 30 ml of 0.5% Ropivacaine for FICB (Fascia iliaca compartment block)  and Group P patients will receive PENG block.

All patients will receive premedication with tablet alprazolam 0.5 mg per oral 2 hours before shifting to the operating theatre. Once the patient is shifted to premedication room, the patient’s vitals were monitored using pulse oximetry, NIBP and ECG. After taking proper aseptic precautions, under ultrasound guidance, Fascia Iliaca Compartment Block will be given using 30 ml of 0.5% ropivacaine on group F patients. Group P patients will receive PENG Block with 20 ml of 0.75% Ropivacaine. After 15 minutes of administration of the block in both the groups, the patients will be shifted to the operation theatre and spinal anaesthesia will be given  using 3 ml of 0.5% bupivacaine (heavy). Intra-operatively patient will be monitored for heart rate, blood pressure, oxygen saturation, input and output monitoring. All the patients will be postoperatively monitored in the  recovery room for 2 hours and then shifted to PACU . Post-operative pain will be assessed by visual analog scale (VAS). Supplementary analgesics i.e. Inj. Paracetamol 1000mg(IV) will be given if the patient had elicited a VAS score of 3 to 5 and Inj. Tramadol 100 mg (IV) will be given if the patient has a VAS score of more than 5. Total consumption of Paracetemol and Tramadol for 24 hours will be noted.

Patient positioning score during spinal anaesthesia was assessed depending on the patient’s sitting comfort during administration of spinal anaesthesia.

0 – not satisfactory,

1 – satisfactory,

2 – Good,

3 – Optimal.

 

 

 

 

VISUAL ANALOG SCALE:

The pain will be assessed by visual analog scale (VAS), measured at rest.

0 = no pain at all

1–2 = mild pain intensity

3–5 = moderate pain intensity

6–8 = severe pain intensity

9–10 = worst pain ever felt.

The duration of postoperative analgesia is defined as the time taken from the completion of FICB and PENG block to the first request for postoperative analgesia (VAS > 3).

If the patient has VAS of 3 to 5 then Inj. Paracetamol 1g IV will be given and for VAS>5, inj tramadol will be given. The total consumption of tramadol and paracetamol will be noted. The occurrence of any adverse effects like nausea, vomiting, itching and respiratory depression will be noted and treated accordingly 
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