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CTRI Number  CTRI/2019/10/021579 [Registered on: 09/10/2019] Trial Registered Prospectively
Last Modified On: 01/10/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Other 
Public Title of Study   We are comparing the decease in pain sensation after giving Femoral nerve block and Nalbuphine intravenously in patients with intertrochanteric fractures  
Scientific Title of Study   Comparative study of effectiveness of femoral nerve block versus Intravenous Nalbuphine in positioning of patients of Intertrochanteric fractures for Spinal anaesthesia. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR Pragna Doppalapudi 
Designation  1st year post graduate trainee 
Affiliation  Kalinga Institute of Mediacal Sciences 
Address  Department of Anaesthesiology,OD 13,Block D,KIMS girls hostel,KIIT,Patia,Bhubaneswar, Odisha

Khordha
ORISSA
751024
India 
Phone  7989062115  
Fax    
Email  dpragna591@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR Pragna Doppalapudi 
Designation  1st year post graduate trainee 
Affiliation  Kalinga Institute of Mediacal Sciences 
Address  Department of Anaesthesiology,OD 13,Block D,KIMS girls hostel,KIIT,Patia,Bhubaneswar, Odisha

Khordha
ORISSA
751024
India 
Phone  7989062115  
Fax    
Email  dpragna591@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Pragna Doppalapudi 
Designation  1st year post graduate trainee 
Affiliation  Kalinga Institute of Mediacal Sciences 
Address  Department of Anaesthesiology,OD 13,Block D,KIMS girls hostel,KIIT,Patia,Bhubaneswar, Odisha

Khordha
ORISSA
751024
India 
Phone  7989062115  
Fax    
Email  dpragna591@gmail.com  
 
Source of Monetary or Material Support  
Dr.Pragna Doppalapudi, OD 13,Block D,KIMS girls Hostel,Department of Anaesthesiology,KIMS,KIIT, Patia,Bhubaneswar, Odisha 
 
Primary Sponsor  
Name  DrPragna Doppalapudi 
Address  OD 13, Block D ,KIMS girls Hostel,KIIT, Patia,Bhubaneswar 
Type of Sponsor  Other [self] 
 
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 
DrAmrita Panda  Kalinga institute of medical sciences  Department of Anaesthesiology,Pradyumna bal memorial hospital,KIMS,KIIT,Bhubaneswar,Odisha
Khordha
ORISSA 
9439862335

amritapanda1323@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee KIMS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M84||Disorder of continuity of bone,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  GROUP A  Patients will receive Femoral nerve block with single injection of 20 ml 0.2% Ropivacaine 15 minutes prior to positioning of patients for spinal anaesthesia 
Comparator Agent  GROUP B  patients will receive 0.1mg/kg bodyweight Nalbuphine intravenously 15 minutes prior to positioning of patients for spinal anaesthesia  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  -Age group 18-80 years;of either sex
-ASA I,II scheduled for intertrochanteric fracture surgeries under spinal anaesthesia.
-patients who give a valid informed consent 
 
ExclusionCriteria 
Details  -Any contra-indication for spinal anaesthesia, femoral nerve block or use of opioids/ local anaesthetics
-patients with polytrauma,infection over injection site
-patients who refuse for participation in study 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare the effect of femoral nerve block vs intravenous Nalbuphine for the ease of patient positioning and relief of pain in patients of intertrochanteric fractures undergoing spinal anaesthesia.  0,2,5,10,15,20 minutes,during positioning 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the time taken to perform spinal anaesthesia between both groups of patients.
To assess patients acceptance.  
0,2,5,10,15,20minutes,during positioning 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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)   01/11/2019 
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="2"
Months="0"
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)?  

Brief Summary  

INTRODUCTION:

Fracture of femur is a common orthopedic problem following trauma in patients of all age groups and spinal anaesthesia is a preferred technique for providing anaesthesia.

Correct positioning during spinal anaesthesia is the pre-requisite for a successful procedure.Extreme pain and limb immobility are deterrants to an ideal positioning for performing the spinal anaesthesia.

Various modalities like the use of intravenous opioids,peripheral nerve blocks have been advocated pre-operatively to reduce the pain during positioning for anaesthesia.

There are very few literatures available regarding superiority of one technique over the other.So,we are conducting this study to compare the effectiveness of femoral nerve block versus intravenous Nalbuphine in positioning of patients of intertrochanteric fractures for spinal anaesthesia.   

AIMS AND OBJECTIVES OF STUDY:

Aim: To evaluate the effectiveness of femoral nerve block versus Intravenous Nalbuphine in positioning of the patients with intertrochanteric fractures for spinal anaesthesia

Primary objective: Ease of positioning of patients for spinal anaesthesia

---Quality of patient position as assessed by anaesthesiologist satisfaction.(0=not satisfactory;1=satisfactory;2=good;3=optimal)  

---Assessment of pain carried out by Visual analogue scale before and during procedure of positioning.

Secondary objective:  

---Time taken to perform spinal anaesthesia between both groups of patients           

---Patient satisfaction  while positioning.(yes/no)   

 

 

Methodology and Materials:

Place of study: The study will be conducted in Department of Anaesthesiology at Kalinga institute of medical sciences,Bhubaneswar, Odisha.

Instituitional approval and informed consent from patients will be taken before performing the procedure and prior to the study.

Study design: Randomized study

Sample size: Considering the power of study to be 80% and level of significance (alpha=0.05) estimated required sample size is 70, 35 being in each group.

Inclusion criteria:

-Age group 18-80 years;of either sex

ASA I,II scheduled for intertrochanteric fracture surgeries under spinal anaesthesia.

-patients who give a valid informed consent

Exclusion criteria:

-Any contra-indication for spinal anaesthesia, femoral nerve block or use of opioids/ local anaesthetics

-patients with polytrauma,infection over injection site

-patients who refuse for participation in study

Randomisation and allocation:

Randomization will be done by computer generated randomization list.Then patients will be allocated to one one of the two groups by opaque sealed envelope technique and will recieve either of two regimen.

Methodology:

Patients will be shifted to pre-operative area.Monitor with NIBP,SpO2,ECG will be connected.Then,

patients will be classified into two groups:

Group A: patients will receive intravenous(IV) Nalbuphine in a dose of 0.1mg/kg bodyweight 15 minutes prior to positioning

 

 

Group B: patients will receive PNS guided using B braun nerve stimulator or USG GUIDED Femoral nerve block(FNB) with 20ml of 0.2% Ropivacaine 15 minutes prior to positioning for spinal anaesthesia. Then patients will be shifted to operation theatre. Monitors will be placed and thereafter, a spinal block will be performed . Block will be given in L2-L3 or L3-L4 space via midline/paramedian approach in sitting position. Pain assessment will be done before and during positioning using Visual analogue scale(0=NO pain to 10=max. Pain)

-The time taken to perform the spinal anaesthesia;

-Anaesthesiologist’s satisfaction with patient position maintained for spinal block

Satisfaction scores marked on visual analog scale

VAS     SATISFACTION SCORE

 0    -  Not satisfactory

 1    -  satisfactory

 2    -  good

 3    -  optimal

-Patient satisfaction will also be noted in both groups of patients(Yes/No)

-Vital parameters:Heart rate,SBP,DBP,MAP,Spo2 will be monitored.

 
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