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CTRI Number  CTRI/2021/08/036003 [Registered on: 27/08/2021] Trial Registered Prospectively
Last Modified On: 25/08/2021
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 of two drugs in anesthesia in abdominal and lower limb surgeries 
Scientific Title of Study   Comparison of 0.5% levobupivacaine alone and 0.5% levobupivacaine with butorphanol given intrathecally in infraumbilical surgeries; a randomised control trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Anushree Pathak 
Designation  Junior Resident Anesthesia 
Affiliation  Rohilkhand Medical College and Hospital 
Address  Department of Anesthesia, Rohilkhand medical college and hospital Bareilly , room number 2071
Department of Anesthesia Rohilkhand Medical College and Hospital Bareilly,room number 2071
Bareilly
UTTAR PRADESH
243006
India 
Phone  9335029261  
Fax    
Email  cuteeanushree@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Akash gupta  
Designation  Assistant professor  
Affiliation  Rohilkhand Medical College and Hospital 
Address  Department of AnesthesiaRohilkhand Medical College and Hospital Bareilly
Department of Anesthesia Rohilkhand Medical College and Hospital Bareilly
Bareilly
UTTAR PRADESH
243006
India 
Phone  9935312219  
Fax    
Email  akku165@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Anushree Pathak 
Designation  Junior Resident Anesthesia 
Affiliation  Rohilkhand Medical College and Hospital 
Address  Department of Anesthesia , Rohilkhand Medical College and Hospital Bareilly, room number 2071
Department of Anesthesia Rohilkhand Medical College and Hospital Bareilly, room number 2071
Bareilly
UTTAR PRADESH
243006
India 
Phone  9335029261  
Fax    
Email  cuteeanushree@gmail.com  
 
Source of Monetary or Material Support  
Department of Anesthesia Rohilkhand medical college and hospital,room number 2071 
 
Primary Sponsor  
Name  Rohilkhand Medical College and Hospital  
Address  Pilibhit bypass road Bareilly  
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 Malti Agarwal  Rohilkhand medical college and hospital   Department of Anesthesia,room number 2071
Bareilly
UTTAR PRADESH 
9358584555

dr_malti_agrawal@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC, Rohilkhand Medical College and hospital Bareilly  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  0.5% Levobupivacaine 3ml once intrathecally for lower limb and lower abdominal surgeries to know the duration of sensory, motor effect and need for the first rescue analgesia will decide the duration of therapy may be 6 hours.  Levobupivacaine is a local anesthetic agent given commonly in spinal anesthesia 
Comparator Agent  0.5% Levobupivacaine 3ml with 100 microgram (0.1ml) butorphanol once intrathecally for lower limb and lower abdominal surgeries to study the duration of sensory and motor effect during the procedure. Need of first rescue analgesia will decide the duration of therapy may be 6 hours.  Butorphanol is an opioid given along with local anesthetic agent like levobupivacaine  
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  American Society of Anesthesiologist (ASA) grade 1 or 2
Posted for surgeries of lower abdomen and lower limb 
 
ExclusionCriteria 
Details  Refusal for procedure
Obesity (BMI>30)
Any neuropathy
Any allergy to local anesthetic
Contraindication to spinal anesthesia 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Efficacy of Butorphanol as an adjuvant to levobupivacaine .
Onset, duration of sensory and motor blockade, peak height, two segment regression time, time for first rescue analgesia will be assessed  
day1 
 
Secondary Outcome  
Outcome  TimePoints 
sensory and motor onset  day 1 
 
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   N/A 
Date of First Enrollment (India)   30/08/2021 
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="1"
Months="0"
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 - NO
Brief Summary  

Spinal anaesthesia was the first major regional technique introduced into the clinical practice.  Spinal anaesthesia is a safe, reliable and also inexpensive technique.  It has the advantage of providing surgical anaesthesia with prolonged post operative pain relief with use of various local anaestheticagents. It also blunts the intra-operative, autonomic, somatic and endocrine responses. Spinal anaesthesia has a faster onset and effective sensory and motor blockade. Spinal anaesthesiawas first performed in 1898 by August Bier. From then on it has been practiced extensively.1

Local anaesthetics interrupt neural conduction by inhibiting the influx of sodium ions through channels or ionophores within neuronal membranes. The molecular structure of all local anaesthetics consists of 3 components, a lipophilic aromatic ring, an ester or amide linkage and tertiary amine. Local anaesthetics are classified as short acting, intermediate and long acting. This is primarily due to differences in their affinity for protein. Bupivacaine most common LA used for regional anaesthesia but it has serious side effects like cardiac and neurotoxic.

Levobupivacaine, the pure S (-) enantiomer of the racemic Bupivacaine is a long acting amide local anaestheticwhich produces differential neuraxial block. It was synthesized aiming at finding local   bupivacaine but without its hazards as cardiac and central nervous system toxicity.  Levobupivacaine exerts its pharmacological action through reversible blockade of neuronal sodium channels.  It binds to the intracellular portion of sodium channels and blocks sodium influx into nerve cells, which prevents depolarization. The pka of levobupivacaine is 8.1, similar to the pka of the racemic bupivacaine.2

 
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