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CTRI Number  CTRI/2024/10/074982 [Registered on: 09/10/2024] Trial Registered Prospectively
Last Modified On: 08/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparative study of intrathecal Levobupivacaine vs Bupivacaine vs Ropivacaine in perianal surgeries  
Scientific Title of Study   A Comparative study of 0.5 percentage hyperbaric Levobupivacaine, 0.5 percentage hyperbaric bupivacaine and 0.75 percentage hyperbaric ropivacaine for subarachnoid block in perianal surgeries : A randomized control trial 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Linda Monica Dsouza 
Designation  Second Year Post Graduate  
Affiliation  St John’s Medical College  
Address  Department of Anesthesiology, Second floor OT complex, St. John’s Medical College Sarjapur-Marathahalli Road Koramangala

Bangalore
KARNATAKA
560034
India 
Phone  9481144595  
Fax    
Email  monicadsouza469@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Bindu George 
Designation  Professor 
Affiliation  St. Johns Medical College 
Address  Department of Anesthesiology, Second floor OT complex, St. Johns Medical College, Bengaluru

Bangalore
KARNATAKA
560034
India 
Phone  9342552324  
Fax    
Email  bindu575@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Bindu George 
Designation  Professor 
Affiliation  St. Johns Medical College 
Address  Department of Anesthesiology, Second floor OT complex, St. Johns Medical College, Bengaluru

Bangalore
KARNATAKA
560034
India 
Phone  9342552324  
Fax    
Email  bindu575@gmail.com  
 
Source of Monetary or Material Support  
Department of Anesthesiology, Second floor OT complex, St. Johns Medical College, Bengaluru - 560034 Karnataka India 
 
Primary Sponsor  
Name  Linda Monica Dsouza 
Address  Department of Anesthesiology, Second floor OT complex, St.John’s Medical College Sarjapur- Marathahalli road Bengaluru- 560034 Karnataka India 
Type of Sponsor  Other [] 
 
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 Linda Monica Dsouza  St John’s Medical College and Hospital  Department of Anesthesiology, Second floor OT complex, St Johns Medical College Sarjapur Road, Bengaluru - 560034
Bangalore
KARNATAKA 
9481144595

monicadsouza469@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, St Johns Medical college, Bengaluru  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 
Intervention  Bupivacaine   Subarachnoid block using 2.5ml of 0.5 % Hyperbaric Bupivacaine in perianal surgeries. Time taken for the intervention is 5 to 20 minutes. 
Comparator Agent  Levobupivacaine   Subarachnoid block using 2.5ml of 0.5% Hyperbaric Levobupivacaine in perianal surgeries. Time taken for the intervention is 5 to 20 minutes. 
Comparator Agent  Ropivacaine   Subarachnoid block using 2.5ml of 0.75% Hyperbaric Ropivacaine in perianal surgeries. Time taken for the intervention is 5 to 20 minutes. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  American Society of Anaesthesiologists (ASA) physical status Grade 1 and Grade 2 patients scheduled for elective or emergency perianal surgery requiring subarachnoid block

 
 
ExclusionCriteria 
Details  1.Patients with spine deformity
2.Pregnant patients
3.Patients with coagulation and bleeding disorders
4.Sensitive to drugs being studied
5.Patient refusal 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare duration of sensory blockade
To compare duration of motor blockade 
Sensory blockade- Time interval between onset of block (T12 dermatomal level)and two segment dermatomal regression
Motor blockade- Time between onset of motor blockade(Modified Bromage scal 3) to complete regression of motor block (Modified Bromage Scale 0 ) 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the onset of action of sensory blockade
 
Time taken to reach T12 dermatomal level assessed by sterile pin prick every 2 minutes till level reached 
To compare onset of motor blockade  Time taken to reach Modified Bromage score of 3 will be assessed every 2 minutes 
Any adverse hemodynamic effects or side effects  Following injection of the drug intrathecally, baseline vitals will be assessed every 3 minutes for first 15 minutes & every 5 minutes thereafter till the end of procedure.
Any side effects like nausea, vomiting, pruritis & sedation will also be noted 
 
Target Sample Size   Total Sample Size="69"
Sample Size from India="69" 
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)   19/10/2024 
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="1"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

A comparative study of 0.5%  Hyperbaric Levobupivacaine, 0.5%  Hyperbaric Bupivacaine and 0.75% Hyperbaric Ropivacaine for spinal anesthesia in perianal surgeries: A randomized control trial                                                                                                                                                                  

 

Spinal anaesthesia is the most efficient technique that provides fast surgical anaesthetic block through very small dose of local anaesthesia into the subarachnoid space. It produces profound nerve block to large part of the body. However, the control of spread of local anaesthetic through the CSF to provide block that is adequate for the proposed surgery is a challenge. Bupivacaine is a racemic mixture containing equal proportions of S and R isomers. It is being used because of its long duration of action and beneficial sensory and motor block. However this might be a disadvantage for short to intermediate duration procedures. Levobupivacaine is S enantiomer of bupivacaine and better alternative to bupivacaine in terms of cardiac and central nervous system toxicity .It produces less motor block than bupivacaine when administered intrathecally at low doses. Ropivacaine is less lipophilic than bupivacaine and has less affinity towards large myelinated motor fibers resulting in relatively reduced motor blockade.This feature of high sensory and low motor affinity is advantageous in cases where motor blockage isn’t desiredPerianal surgeries are short procedures that require good intra operative anesthesia and post operative analgesia since perianal region have dense sensory supply. Hence profound sensory block over motor block for short period is desired. This study will be done to compare the duration of sensory and motor blockade of 0.5% hyperbaric bupivacaine, 0.5% hyperbaric levobupivacaine and 0.75% hyperbaric ropivacaine. This study will include 69 ASA 1 and ASA 2 patients between the age group of 18 to 65 years undergoing perianal surgeries. Patients will be divided into 3 groups (23 each)  randomly via computer generated sequence. A detailed preanesthetic evaluation and all relevant investigations will be done a day prior to surgery. All patients will be informed about the anaesthetic procedure and an informed consent will be taken for the same. Patients will be kept nil per oral- 6 hours for solids and 2 hours for clear liquids. Tablet Alprazolam 0.25mg will be given the night before the surgery and Tablet Pantoprazole 40 mg morning of the surgery. All patients will have a patent 20 Gauge intravenous peripheral line and will be preloaded with 500 ml of Ringer lactate solution.On the day of surgery, baseline vitals will be recorded. The patients will be monitored using standard monitors - Pulse Oximeter, Electrocardiogram (ECG) and Noninvasive Blood Pressure (NIBP).Under strict aseptic precaution, patient in sitting  position, local anesthesia of skin will be given with 2ml of 2% lignocaine at L2-3 or L3-4 intervertebral space. Lumbar puncture will be done using 25G Quincke Babcock spinal needle. The drug will be injected slowly after confirming free and clear backflow of CSF. After injecting the drug, the patient will be made to sit for 1minute and then lie down in supine position. The primary outcome variable will be the duration of sensory and motor blockade. This will include the time taken for two segment regression and degree of block assessed by Modified Bromage scale. The secondary outcome will be to compare the onset of sensory and motor blockade. This will be assessed by time taken for the block to reach T12 and modified Bromage of 4.Any adverse hemodynamic effects will be added as secondary variable.The data collected will be tabulated for statistical analysis

 


 
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