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CTRI Number  CTRI/2023/02/049704 [Registered on: 14/02/2023] Trial Registered Prospectively
Last Modified On: 13/02/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison the efficacy of 0.5 % hyperbaric levobupivacaine with 0.5% levobupivacaine plus fentanyl in lower limb orthopaedics surgery under spinal anaesthesia.  
Scientific Title of Study   Comparison of 0.5% hyperbaric levobupivacaine with 0.5% hyperbaric levobupivacaine plus fentanyl in lower limb orthopaedic surgery under 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 MANDAKINI KATIYAR 
Designation  Postgraduate Resident  
Affiliation  Peoples college of medical science and research centre bhopal. 
Address  Department of anaesthesia peoples College of medical sciences and research centre.bhopal.

Bhopal
MADHYA PRADESH
462037
India 
Phone  09769422467  
Fax    
Email  mandakinikatiyar.23@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  dr sourabh jain  
Designation  associate professor  
Affiliation  peoples college of medical sciences and research center.bhanpur bhopal  
Address  department of anaesthesia Peoples college of medical sciences and research centre. bhopal MP MADHYA PRADESH 462001 INDIA
Department of anaesthesia. Peoples college of medical sciences and research centre.bhopal
Bhopal
MADHYA PRADESH
462001
India 
Phone    
Fax    
Email  ph.anaesthsia@peoplesuniversity.edu.in  
 
Details of Contact Person
Public Query
 
Name  DrMandakini katiyar 
Designation  Postgraduate Resident 
Affiliation  peoples college of medical sciences and research center bhanpur, bhopal  
Address  Department of anaesthesia. Peoples college of medical sciences and research centre. bhopal MP BHOPAL MADHYA PRADESH 462001 INDIA
Department of anaesthesia.peoples college of medical sciences and research centre.bhopal
Bhopal
MADHYA PRADESH
462001
India 
Phone    
Fax    
Email  mandakinikatiyar.23@gmail.com  
 
Source of Monetary or Material Support  
Department of anaesthesia .peoples college of medical science and research centre,bhopal ( madhya pradesh ) .462037 
 
Primary Sponsor  
Name  Mandakini katiyar 
Address  Department of anaesthesia peoples medical college and research center. bhopal MP 
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 
Mandakini katiyar  Peoples college of medical science and research center  Department of anaesthesia, peoples college of medical sciences and research center, bhopal MP
Bhopal
MADHYA PRADESH 
09769422467

mandakinikatiyar.23@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
peoples college of medical science and research center institutional ethics comittee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M236||Other spontaneous disruption of ligament(s) of knee, (2) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  0.5% hyperbaric levobupivacaine   levobupivacaine , a pure (-) enantiomer of racemic bupivacaine and has low cardiotoxicity and less undesired effects on central nervous system because of its significantly low side effects,levobupivacaine seems to be an attractive alternative to bupivacaine.it produces localized anaesthesia by blocking the transmission of action potential in sensory,motor,and sympathetic nerves fibers ,by inhibiting the passage of sodium through voltage sensitive ion channels in the neuronal membrane.the duration of drugs will be seen till drug effect weans off. 
Comparator Agent  0.5%levobupivacaine plus fentanyl  fentanyl is a potent synthetic opioid with a strong agonistic action at the mu opioid receptor with a rapid onset and short duration of action.fentanyl when added to local anaesthetic in spinal anaesthesia ,potentiates the action via central opioid receptor mediated analgesia by the peripheral uptake of fentanyl to the system circulation.opiates are widely known to have an analgesic effect at the central and spinal cord level.the effect will be seen till the drug effect weans off. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ASA GRADE 1 AND 2.
SCHEDULED FOR ELECTIVE LOWER LIMB ORTHOPAEDICS SURGERIES UNDER SPINAL ANAESTHESIA. 
 
ExclusionCriteria 
Details  1. LACK OF PATIENTS CONSENT.
2. PATIENT REFUSALFOR SPINAL ANESTHESIA.
3.HISTORY OF SERIOUS PULMONARY DISEASE,ISCHEMIC HEART DISEASE,RENAL/HEPATIC DYSFUNCTION ,CORONARY ARTERY,OR CERVICAL SPINE DISEASE AND PATIENTS WITH ABNORMAL COAGULATION PROFILE.
4. PATIENTS WITH LOCAL SKIN SITE INFECTION.
5.PATIENTS WITH HYPERSENSTIVITY TO ANY OF THE DRUGS USED.
6.PREGNANT AND LACTATING MOTHERS. 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
●To study and compare the onset of analgesia, duration of sensory blockade , motor blockade, hemodynamics parameters ( SBP,DBP,MAP,HR) of 0.5% hyperbaric levobupivacaine and 0.5% hyperbaric levobupivacaine with fentanyl.


 
first 24 hour at immediately after block,at 5min,10min,15min,20 min,25min ,30 min,60 min,90min,120 min,180 min,240 min ,300min. 
 
Secondary Outcome  
Outcome  TimePoints 
to compare the side effects of 0.5% hyperbaric levobupivacaine and 0.5% hyperbaric levobupivacaine with fentanyl.

 
first 24 hour at immediately after block,at 5min,10min,15min,20 min,25min ,30 min,60 min,90min,120 min,180 min,240 min ,300min. 
 
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)   15/02/2023 
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 Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   none yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   various clinical trials have found that administration of fentanyl with local anaesthetic in spinal anaesthesia prolonged the duration of sensory and motor blockade.

however ,there are limited data available on comparing of fentanyl as adjunvant to levobupivacaine in spinal anaesthesia.so we want to compare whether adding fentanyl tolevobupivacaine for spinal anaesthesia would affect the sensory and motor blocks and duration of analgesia.the present work has been undertaken to study and compare the effect provided by fentanyl as adjuvants to levobupivacaine in spinal anaesthesia.
 
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