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CTRI Number  CTRI/2021/07/034793 [Registered on: 13/07/2021] Trial Registered Prospectively
Last Modified On: 12/07/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   calculation of the effective dose of Levo-bupivacaine(0.5%)and Ropivacaine(0.5%) in unilateral spinal anaesthesia 
Scientific Title of Study   Determination of the median effective dose(ED50) of Levo-bupivacaine(0.5%)and Ropivacaine(0.5%)in unilateral 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 Mittal Patel 
Designation  Resident Doctor in Department of Anaesthesiology 
Affiliation  Goverment Medical College,baroda. 
Address  Department of Anaesthesiology,Goverment Medical College and SSG Hospital,Anandpura,Vadodara,Gujarat-390001,India

Vadodara
GUJARAT
390001
India 
Phone  8401251948  
Fax    
Email  dr.mittal1808@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Mamta Patel 
Designation  Associate professor in Department of Anaesthesiology  
Affiliation  Goverment Medical College,baroda. 
Address  Department of Anaesthesiology,Goverment Medical College and SSG Hospital,Anandpura,Vadodara,Gujarat-390001,India

Vadodara
GUJARAT
390001
India 
Phone  9825453024  
Fax    
Email  mgpatel111@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Mamta Patel 
Designation  Associate professor in Department of Anaesthesiology  
Affiliation  Goverment Medical College,baroda. 
Address  Department of Anaesthesiology,Goverment Medical College and SSG Hospital,Anandpura,Vadodara,Gujarat-390001,India

Vadodara
GUJARAT
390001
India 
Phone  9825453024  
Fax    
Email  mgpatel111@yahoo.com  
 
Source of Monetary or Material Support  
department of anaesthesiology,new surgical block,goverment medical collage,vadodara 
 
Primary Sponsor  
Name  Goverment Medical College baroda 
Address  Department of Anaesthesiology,Goverment Medical College and SSG Hospital,Anandpura,Vadodara,Gujarat 390001,India 
Type of Sponsor  Government 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 
DrMittal patel  ssg hospital,vadodara  general surgery opration theatre,2nd floor,new surgical block,ssg hospital,vadodara,gujrat.
Vadodara
GUJARAT 
8401251948

dr.mittal1808@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee for biomedical and health research(IECHBR) medical collage and ssg hospital,vadodara  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,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Inj Levo-Bupivacaine 0.5% given intrathecally  The first patient in group L will be received 0.5% Levo-bupivacaine 1ml (5.0 mg) The testing interval will be 0.5 mg. If the response of the previous patient will effective, the dose of intrathecal local anesthetic for the next patient will be decreased by 0.5 mg in that group Conversely, if the response of the patient will be ineffective, the dose of intrathecal local anesthetic for the next patient will increase by 0.5 mg in that group.  
Intervention  Inj.Ropivacaine 0.5% given intrathecally  the first patient in group R will be received 0.5% Ropivacaine1ml(5.0 mg). The testing interval will be 0.5 mg. If the response of the previous patient will effective, the dose of intrathecal local anesthetic for the next patient will be decreased by 0.5 mg in that group. Conversely, if the response of the patient will be ineffective, the dose of intrathecal local anesthetic for the next patient will increase by 0.5 mg in that group.  
Comparator Agent  Levo-bupivacaine and Ropivacaine  Group L-Patients will be receiving Inj LevoBupivacaine 0.5% intrathecally Group R- Patients will be receiving Inj. Ropivacaine 0.5% intrathecally 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ASA-I/II
Elective unilateral limb(below knee) surgeries like amputation,debridement.
Height-between 5feet and 6feet 
 
ExclusionCriteria 
Details  Patients with absolute and relative contraindications to spinal anaesthesia (Patient refusal, Local skin infection, Vertebral column abnormalities, bleeding disorders, sever hypovolemia, thyroid disorders, cardiopulmonary disease, neuropathies ,severely altered mental status)
Patients with history of diabetes, renal or hepatic disease
Patients with allergy to local anaesthetics
Pregnant and lactating females
Morbid obesity(BMI>29 kg/square metre)

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
-sensory and motor characteristics
-to observe any changes in hemodynamic parameters like pulse rate,blood pressure,respiratory rate,ECG,SpO2 perioperatively 
Time from administration of drug intrathecally till 24 hours 
 
Secondary Outcome  
Outcome  TimePoints 
to observe any complications like bradycardia,hypotention,nausea/vomiting,pruritus,shivering, urinary retention.  Time from administration of drug intrathecally till 24 hours 
 
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 2 
Date of First Enrollment (India)   26/07/2021 
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)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [dr.mittal1808@gmail.com].

  6. For how long will this data be available start date provided 04-03-2021 and end date provided 09-03-2022?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  

Informed Written consent:  yes

    Anaesthesia Technique:

·       Patients will be thoroughly counselled during the pre-operative evaluation and will be properly explained about the procedure, and study before taking the written consent.

·       Patients will be kept nil by mouth for 8 hours.

·       In the operation Theatre, a good venous access will be secured with 18G IV cannula and all the patients will be preloaded with 8 ml/kg of Ringer’s lactate solution.

 

Premedication:

·       Injection Ondansetron 4mg(0.1mg/kg)IV 5 min before induction

·       Injection Glycopyrrolate 0.2mg/kg  (5 mcg/kg)IV5 min before induction

 

·    All baseline parameters will be observed and recorded which consist of Electrocardiography(ECG), Heart rate(HR), Non-invasive Blood Pressure(NIBP) and Pulse Oximeter(SpO2) ,Respiratory Rate before the procedure.

·    Basic necessities like Anaesthesia machine, monitors,  resuscitation drugs, airway equipments and suction apparatus and equipment for spinal anaesthesia will be checked.

 

The patient will be kept in  lateral position with the limb to be operated on the lower side

•     Under all Aseptic & Antiseptic precautions spinal anesthesia will be given in L3 –L4 intervertebral space in all cases. 25G Quincke Spinal needle will be inserted. After confirmation of free CSF flow,with the bevel of the needle pointing down , study drug will be injected at the rate of 0.1ml/Second intrathecally according to Group.

•     Patient is made to remain in lateral position for 10 minutes.Monitoring of parameters will be started immediately on making the patient supine.

•     Surgery will be allowed once the peak sensory(T12) and motor blockade (Bromage 3)are achieved.

•     The study drug for spinal anesthesia will be prepared before anesthesia by an anesthesia assistant , who will not participate in the subsequent patient assessment. The solutions will be administered by a second attending anesthesiologist ,who will be blinded to the drug used.

•     If during study, there is failure of spinal anaesthesia or supplementation of general anaesthesia is required then that case will be excluded from study.

 

 

 

 

DRUG  PREPARATION-

Group L- Inj Levo-Bupivacaine 0.5% 1ml(5mg)

Group R-Inj. Ropivacaine 0.5% 1ml(5mg)

 

 The first patient in group L will be received 0.5% Levo-bupivacaine 1ml (5.0 mg) and the first patient in group R will be received 0.5%  Ropivacaine1ml(5.0 mg).

 The testing interval in each group will be 0.5 mg. If the response of the previous patient will effective, the dose of intrathecal  local anesthetic for the next patient will be decreased by 0.5 mg in that group.

Conversely, if the response of the patient will be ineffective, the dose of intrathecal  local anesthetic for the next patient will increase by 0.5 mg in that group.

An effective outcome will be defined as a T12 sensory blockade level maintained for more than 60 min, and a Bromage score of 3 on the operation side within 10 min after injection otherwise the outcome was ineffective.

 The ED50 of 0.5% Levo-bupivacaine and 0.5% ropivacaine will be calculated using the Dixon and Massey formula( annexure 2)

 

 

·          For ensuring blinding, randomly allocated coded syringes of drugs will be prepared after taking all aseptic and antiseptic precautions by a fellow anesthesiologist not involved in performing subarachnoid block or recording of the outcome during intraoperative and postoperative periods. The Patient and theAnesthesiologist performing subarachnoid block will be blinded to the content of the drug.The content of the drug will be unblinded after 24 hours of performing subarachnoid block.

 

 

 

 
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