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CTRI Number  CTRI/2017/09/009665 [Registered on: 06/09/2017] Trial Registered Retrospectively
Last Modified On: 09/03/2017
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   to see which method is better for pain relief in making a patient with fracture femur sit before spinal anaesthesia  
Scientific Title of Study   Comparison between femoral nerve block and intravenous fentanyl for Analgesia before performing a spinal block in the sitting position in patients with femoral shaft fracture. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  dr umesh kumar bhadani 
Designation  professor 
Affiliation  AIIMS 
Address  department of anaesthesia, OT complex, 3rd floor, AIIMS,Patna

Patna
BIHAR
801505
India 
Phone    
Fax    
Email  umeshbhadani@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  dr umesh kumar bhadani 
Designation  professor 
Affiliation  AIIMS 
Address  department of anaesthesia, OT complex, 3rd floor, AIIMS,Patna

Patna
BIHAR
801505
India 
Phone    
Fax    
Email  umeshbhadani@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Umesh Kumar Bhadani 
Designation  Professor 
Affiliation  All India Institure of Medical Sciences(AIIMS),Patna 
Address  Department of Anaesthesia, OT complex, 3rd floor, All India Institure of Medical Sciences(AIIMS),Patna

Patna
BIHAR
801505
India 
Phone    
Fax    
Email  umeshbhadani@gmail.com  
 
Source of Monetary or Material Support  
All India Institure of Medical Sciences(AIIMS),Phulwarisharif, Patna 
 
Primary Sponsor  
Name  All India Institure of Medical SciencesAIIMS 
Address  Phulwarisharif, Patna 
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 Umesh Kumar Bhadani  All India Institure of Medical Sciences(AIIMS),Patna  OT complex, 3rd floor, PMR building, AIIMS,Patna
Patna
BIHAR 
08969169123

umeshbhadani@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS patna institutional ethics commitee( human studies)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  ASAI/II,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  femoral nerve block  1 % lignocaine 15 ml femoral nerve block  
Intervention  FENTANYL 1 ug/kg   fentanyl 1 ug/kg followed by 0.5 ug/kg if VAS 4 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Age 18 to 80 years
2. ASA I/II
3.Scheduled for fracture femur operation under central neuraxial block 4. Unable to sit due to pain
 
 
ExclusionCriteria 
Details  ASA III OR MORE 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Pain Scoring(VAS Score)  5 minutes from the time of intervention( baseline) 
 
Secondary Outcome  
Outcome  TimePoints 
1. Hemodynamics (Heart Rate, Mean Arterial Pressure) and peripheral oxygen saturation  Baseline and after 5 minutes from baseline 
 
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   Phase 1 
Date of First Enrollment (India)   01/10/2016 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   none yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

 

Fracture of femur is a particularly painful bone injury because the periosteum has the lowest pain threshold of the deep somatic structures. Surgical repair most commonly involves either internal fixation of the fracture or replacement of the femoral head with arthroplasty. At our institution, spinal block was used more frequently than general anaesthesia (GA) for femoral fracture surgery. Correct positioning during central neuraxial block is the prerequisite for a successful procedure. However, limb immobility and extreme pain are the deterrents for an ideal positioning for this procedure. Various modalities like intravenous (IV) fentanyl (FENT), femoral nerve block (FNB) or fascia iliaca block with local anaesthetic have been advocated to reduce the pain pre-operatively and improve the positioning of these patients. There are few data to establish a benefit of one form of anaesthetic over another in this situation. This prospective study will be performed to compare the analgesic effects of FNB with intravenous (IV) fentanyl prior to positioning for spinal block in patients with fractured femur.

AIM OF THE STUDY

The present study is to compare the analgesic effect of femoral nerve block(FNB) with intravenous (IV) fentanyl prior to positioning patient with fracture femur for spinal block.

PLACE OF WORK

Department of anaesthesiology

AIIMS Patna

MATERIAL AND METHOD

Material:- 

A.    Patients

B.     Drugs

C.     Equipments

A.      Patients

INCLUSION CRITERIA

   1. Age 18 to 80 years

2. ASA I/II

3.Scheduled for fracture femur operation under central neuraxial block                                                  4.  Unable to sit due to pain

 

       EXCLUSION CRITERIA

1.      ASA III or more

2.      Multiple fractures

3.      Patients who sit comfortably

4.       Allergy to the drugs

5.      Coagulopathy

6.      Infection at puncture site

7.      Mental disorder and Communication failure

8.      Use of analgesia for premedication

9.      Preexisting neurological disease like peripheral neuropathy

B. Drugs

     Inj lignocaine 1.5%

     Inj Fentanyl

     Various i.v fluid

     All emergency drugs

C. Equipments

    Anaesthesia machine

    Multi parameter  monitor (NIBP, Pulse oxymetry, ECG)

    Suction apparatus, Laryngoscope, ET tube, All resuscitative equipment kept ready

                  METHOD

Informed consent will be taken for the study. The patient will be examined and evaluated on the day before surgery. They will be explained the procedure of anaesthesia to allay anxiety and apprehension.

 In this randomized prospective study 60 patients having fracture femur will be entered. Premedication such as oral benzodiazepines (alprazolam 0.25mg) will be given at bed time on the day before surgery. The patients will be allocated by computer-generated random numbers into two groups of 30 patients each: an FNB group and IV FENT group.

 

FNB group will receive 20 mL of 1.5% lignocaine 5 min before positioning for spinal block.

FENT group will receive injection fentanyl 1 μg/kg IV 5 min prior to positioning.

 

 The random allocation sequence is concealed in opaque, sealed envelopes until a group was assigned. On arrival in the induction area, all patients will be monitored with electrocardiography, pulse oximeter, and non-invasive blood pressure measurement. An IV line will be secured and infusion of lactated Ringer’s solution started as maintainance and all patients supplied with oxygen (6 L/min) via a face mask. Patients in the FNB group will receive FNB under ultrasonic guidance 5 min before positioning for spinal block. FNB will be performed by one of two anaesthesiologists. Entry point will be infiltrated with 1 ml 1% lignocaine.  After visualisation of femoral nerve in USG 20 mL of 1.5% lignocaine will be injected incrementally after a negative aspiration test. Patients in the FENT group will receive injection fentanyl 1 μg/kg IV 5 min prior to positioning. If any patient in either group reports pain scores ≥4 during positioning, IV fentanyl 0.5 μg/kg will be given every 5 min until the pain score decreased to <4 or maximum dose of 3 μg/kg will be given (whichever first); if pain score <4 could not be achieved, patients will be excluded from study. Spinal block will be performed by anaesthesiologist who is blinded for the study. The spinal block will be performed either by the midline or paramedian approach at the L2/3 or L3/4 level, according to the anaesthesiologist’s decision.

 

ASSESSMENT

Following methodology will be used for assessment of parameters.

 

1. Pain score using visual analogue scale (0 = no pain , 10 = maximal pain)

2. Additional fentanyl requirements during positioning.

3. Patient positioning and satisfaction of anaesthesiologist for spinal block by satisfaction scale (0 = not satisfactory, 1 = satisfactory, 2 = good, 3 = optimal).

4. Patient discomfort (YES or NO).

5. Vital parameters:- heart rate (HR), mean arterial pressure (MAP) by non-invasive blood pressure and oxygen saturation (SpO 2 ) will be monitored.

6. Side effects

 
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