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CTRI Number  CTRI/2023/01/048724 [Registered on: 04/01/2023] Trial Registered Prospectively
Last Modified On: 03/01/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To compare effect of two different local anaesthetic drugs given through spinal anaesthesia 
Scientific Title of Study   TO COMPARE BLOCK CHARACTERISTICS OF INTRATHECAL HYPERBARIC LEVOBUPIVACAINE WITH FENTANYL VERSUS INTRATHECAL HYPERBARIC BUPIVACAINE WITH FENTANYL IN UROLOGICAL SURGERIES: A Randomized Double-Blind Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vikash Kumar 
Designation  Junior Resident 1 
Affiliation  Indira Gandhi Institute Of Medical Sciences 
Address  Anaesthesia Dept ,first floor, IGIMS , Sheikhpura , Patna

Patna
BIHAR
800014
India 
Phone  8409697069  
Fax    
Email  vkskmc@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Mumtaz Hussain 
Designation  Additional Professor 
Affiliation  Indira Gandhi Institute Of Medical Sciences 
Address  Anaesthesia Dept, first floor, IGIMS, Sheikhpura, Patna

Patna
BIHAR
800014
India 
Phone  9473376853  
Fax    
Email  drhussain72@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr Mumtaz Hussain 
Designation  Additional Professor 
Affiliation  Indira Gandhi Institute Of Medical Sciences 
Address  Anaesthesia Dept, first floor, IGIMS, Sheikhpura, Patna

Patna
BIHAR
800014
India 
Phone  9473376853  
Fax    
Email  drhussain72@yahoo.co.in  
 
Source of Monetary or Material Support  
Vikash Kumar, Anaesthesia Dept ,first floor, IGIMS , Sheikhpura , Patna Patna BIHAR 800014 India  
 
Primary Sponsor  
Name  Vikash Kumar 
Address  Anaesthesia Dept, first floor,IGIMS, Sheikhpura, Patna  
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 
Vikash Kumar   Urology operation theatre of IGIMS, Patna   Urology OT , first floor, IGIMS, Sheikhpura, Patna
Patna
BIHAR 
8409697069

vkskmc@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N398||Other specified disorders of urinary system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Hyperbaric bupivacaine and fentanyl  Hyperbaric bupivacaine at 12.5mg with fentanyl at 25mcg in subarachanoid space by spinal needle after regular backflow of csf  
Intervention  Hyperbaric Levobupivacaine and fentanyl  Hyperbaric levobupivacaine at 12.5mg with fentanyl at25mcg with spinal needle in subarachnoid space after regular backflow of csf 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Patients of ASA physical status 1, 2
Patients able to comprehend and willing to participate.
Patients scheduled for general elective surgeries
 
 
ExclusionCriteria 
Details  Patients who refuse to participate
Patients allergic to levobupivacaine and/or bupivacaine
Patients having infection at drug administration site
Patient having coagulopathy
Patient having pre existing neurological condition
Raised intracranial pressure
Any other absolute contraindication to spinal anaesthesia
Uncooperative patients
Body weight above 100 kg  
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
To compare the block characteristics in regard of onset and duration of sensory and motor blockade between two group
 
Upto 3hours
 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the hemodynamic parameters and adverse effects between them  24hours postoperative 
 
Target Sample Size   Total Sample Size="176"
Sample Size from India="176" 
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 4 
Date of First Enrollment (India)   05/01/2023 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Planning to publish after completion of thesis 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Patients will be randomised 1:1 using sealed envelope technique into two groups of 88 each and study drug will be prepared by an anaesthesiologist not involved in the study. Group A (n=88) will receive 12.5mg (2.5 ml) of 0.5% hyperbaric levobupivacaine and fentanyl 25 mcg (0.5 ml) while Group B (n=88)  will receive 12.5mg (2.5 ml) of 0.5% hyperbaric bupivacaine and fentanyl 25 mcg (0.5 ml).

Thorough pre�’anesthesia check�’up will be done a day prior to surgery that is, detailed history, general physical examination, systemic examination, airway assessment and lumbar spine examination. Patients will be kept nil by mouth 6 hours for light meal and 2 hours for clear fluids before surgery. The anaesthesia plan will be  explained to the patients.

No premedication will be administered. Hemodynamic parameters will be recorded with ECG, systolic and diastolic blood pressure, heart rate and oxygen saturation (SpO2). Intravenous prehydration with 500 ml of 0.9% isotonic NaCl infusion will be administered. Hypotension, defined as a decrease of systolic blood pressure more than 20% from baseline or a fall below 90 mmHg, will be treated with intravenous doses of 3mg of ephedrine and intravenous fluid as required, and bradycardia, defined as heart rate below 50 beats/min, will be treated with 0.3–0.6mg of intravenous atropine. 

Patients will be placed on the operation table in the sitting position and will be administered 3 ml (60mg) 2% lidocaine infiltration anesthesia through L3–4 after sterilization with antiseptic solution (povidone iodine). The intrathecal space will be reached with a standard Quincke spinal needle of appropriate size. 

Non traumatic pin prick in the mid clavicular line with a blunt needle will be used for sensorial block evaluation (onset, offset) and sensorial block reversal time.

Bromage scale will be used for assessment of the intensity of motor block. In the Bromage scale, the intensity of motor block is assessed by the patient’s ability to move their lower extremities as follows: 0=free movement of legs and feet; 1=just able to flex knees with free movement of feet; 2=unable to flex knees, but with free movement of feet; and 3=unable to move legs or feet.

Onset of motor block  is recorded as when Bromage scale is ‘1’ after administration of local anesthetics, and ‘onset of highest motor block’ is recorded as time to reach the highest scale of motor block that is Bromage scale 3. ‘Operation duration’ is recorded as time until end of operation after administration of local anesthetics. 

The hemodynamic parameters [systolic, diastolic blood pressure, mean blood pressure, heart rate and oxygen saturation (SpO2)] were recorded at 0 and every 10 min after injection of local anaesthesia.

Side effects like hypotension, bradycardia, shivering, nausea and vomiting will be followed-up 24 hour postoperatively.

 
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