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CTRI Number  CTRI/2023/02/049446 [Registered on: 06/02/2023] Trial Registered Prospectively
Last Modified On: 04/02/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   comparative study to identify effect levobupivacaine vs bupivacaine in spinal anesthesia for below umbilical surgeries 
Scientific Title of Study   A comparative study of anesthetic efficacy of 0.5 % Hyperbaric levobupivacaine Vs 0.5 % Hyperbaric bupivacaine for intrathecal anesthesia in below umbilical surgeries- A Prospective Randomized Study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR SENTHIL KUMARB 
Designation  FIRST YEAR POSTGRADUATE  
Affiliation  sri manakula vinayagar medical college and hospital  
Address  NO-109,DEPARTMENT OF ANESTHESIA, SRI MANAKULA VINAYAGAR MEDICAL COLLEGE, MADAGADIPET, PONDICHERRY

Pondicherry
PONDICHERRY
605107
India 
Phone  9791555127  
Fax    
Email  senthil1976.sk@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DRSUNEETH P LAZARUS 
Designation  HOD ANESTHESIA  
Affiliation  SRI MANAKULA VINAYAGAR MEDICAL COLLEGE AND HOSPITAL  
Address  NO-109,DEPARTMENT OF ANESTHESIA, SRI MANAKULA VINAYAGAR MEDICAL COLLEGE, MADAGADIPET, PONDICHERRY

Pondicherry
PONDICHERRY
605107
India 
Phone  9894332543  
Fax    
Email  lazarus.suneeth@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DRSUNEETH P LAZARUS 
Designation  HOD ANESTHESIA  
Affiliation  SRI MANAKULA VINAYAGAR MEDICAL COLLEGE AND HOSPITAL  
Address  NO-109,DEPARTMENT OF ANESTHESIA, SRI MANAKULA VINAYAGAR MEDICAL COLLEGE, MADAGADIPET, PONDICHERRY

Pondicherry
PONDICHERRY
605107
India 
Phone  9894332543  
Fax    
Email  lazarus.suneeth@gmail.com  
 
Source of Monetary or Material Support  
sri manakula vinayagar medical college and hospital  
 
Primary Sponsor  
Name  sri manakula vinayagar medical college and hospital 
Address  NO-109 DEPARTMENT OF ANESTHESIA SRI MANAKULA VINAYAGAR MEDICAL COLLEGE AND HOSPITAL MADAGADIPET PONDICHERRY 
Type of Sponsor  Private medical college 
 
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 SENTHIL KUMAR B  SRI MANAKULA VINAYAGR MEDICAL COLLEGE AND HOSPITAL   NO-109 DEPARTMENT OF ANESTHESIA
Pondicherry
PONDICHERRY 
9791555127

senthil1976.sk@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SMVMCH-EC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  to compare the effect of levobupivacaine to standared bupivacaine dose administered intrathecally   3ml of 0.5% hyperbaric bupivacaine total of 15mg will be given once in subarachnoid space  
Intervention  to study the anesthetic efficacy of levobupivacaine when given intrathecally for spinal anesthesia   3 ml of 0.5% hyperbaric levobupivacaine total of 15mg will be given once in subarachnoid space  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patients scheduled to undergo elective infra umbilical surgeries under spinal anesthesia for next one year from the date of clearance from Ethical committee.
2. Patients of ASA physical status 1 & 2.
3. Patients of either sex.
4. Age >18 years or < 60 years.
5. Patients with height more than 150 cm
 
 
ExclusionCriteria 
Details  1. Body Mass Index >30.
2. Patients with local site infection, allergy to the drugs that are to be tested
or any othercontraindications for spinal anesthesia.

3. Patients who cannot lie down/ non-co-operative/ psychiatric illness.
4. Alcoholics.
5. Pregnant / Lactating women.
6. Patient having failed spinal, transformed into general anesthesia will be excluded from
study.

7. Patients refusal for participation in the study.
8. Patients with height less than 150 cm.
 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the sub-arachnoid block characteristics between 0.5% hyperbaric Levobupivacaine and 0.5% hyperbaric bupivacaine in below umbilical surgeries.  to assess the sensory blockade every 2 mins till 20mins
to assess the motor blockade every 5mins till maximum level achieved  
 
Secondary Outcome  
Outcome  TimePoints 
to assess difference in hemodynamic parameter between both the groups
to assess the adverse reaction between two groups  
10mins before spinal then at 5 mins every 10 mins for the first half an hour and at 1 hr 2 hrs 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   08/02/2023 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   not yet published  
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

This study is a prospective double-blinded randomized trial comparing the anesthetic efficacy of 0.5 % Hyperbaric levobupivacaine and 0.5 % Hyperbaric bupivacaine for intrathecal anesthesia in below umbilical surgeries. The primary outcome is to compare the sub-arachnoid block characteristics between 0.5% hyperbaric Levobupivacaine and 0.5% hyperbaric bupivacaine in below umbilical surgeries. Sensory blockade will be assessed after the injection every 2 minutes till and motor blockade is assessed by modified bromage scale every 5 min until the maximum motor block is achieved having a stable sensory level for the next 20 mins. The secondary objective is to assess and compare hemodynamic parameters between the group, hemodynamic parameters – systolic blood pressure, diastolic blood pressure, mean arterial pressure (MAP), heart rate and oxygen saturation are to be recorded 10 minutes prior to the procedure and then at 5 mins, every 10 mins for the first half an hour and at 1 hr., 2 hrs. Tassess and compare adverse effects between the group  (nausea & Vomiting, adverse drug reaction, arrhythmia, respiratory depression). The time taken for the first rescue analgesia in the immediate post-operative period will be noted in both groups. Intravenous PARACETAMOL at 15 mg/kg will be used as the Rescue analgesia. Any adverse drug reactions to the drugs will be reported to the ethics committee within 24 hours of the occurrence of the event.


 
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