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CTRI Number  CTRI/2018/05/013574 [Registered on: 01/05/2018] Trial Registered Prospectively
Last Modified On: 18/11/2019
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   This is a clinical trial to study and compare two drugs, chloroprocaine and bupivacaine for the benefits of patients undergoing short period of surgeries or day procedures who can be discharged early.  
Scientific Title of Study   Spinal anaesthesia with hyperbaric bupivacaine and isobaric 1%-2chloroprocaine for short duration surgeries: Prospective randomized double blind comparative study  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Valluri Tejasree 
Designation  MD Anesthesiologist, assistant professor 
Affiliation  Gayatri Vidya parishad institute of health care and medical technology 
Address  Department of anaesthesiology, Gayatri Vidya parishad institute of health care and medical technology, 6-25, Maridi valley, Marikavalasa, Madhurawada, Visakhapatnam, Andhra Pradesh
Maridi valley, Marikavalasa
Visakhapatnam
ANDHRA PRADESH
530048
India 
Phone  9949034599  
Fax  08912590131  
Email  drvalluritejasree@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Valluri Tejasree 
Designation  MD Anesthesiologist, assistant professor 
Affiliation  Gayatri Vidya parishad institute of health care and medical technology 
Address  Department of anaesthesiology, Gayatri Vidya parishad institute of health care and medical technology, 6-25, Maridi valley, Marikavalasa, Madhurawada, Visakhapatnam, Andhra Pradesh
6-25, Maridi valley, Marikavalasa, Madhurawada, Visakhapatnam 530048
Visakhapatnam
ANDHRA PRADESH
530048
India 
Phone  9949034599  
Fax  08912590131  
Email  drvalluritejasree@gmail.com  
 
Details of Contact Person
Public Query  
Name  Valluri Tejasree 
Designation  MD Anesthesiologist, assistant professor 
Affiliation  Gayatri Vidya parishad institute of health care and medical technology 
Address  Department of anaesthesiology, Gayatri Vidya parishad institute of health care and medical technology, 6-25, Maridi valley, Marikavalasa, Madhurawada, Visakhapatnam, Andhra Pradesh
6-25, Maridi valley, Marikavalasa, Madhurawada, Visakhapatnam 530048
Visakhapatnam
ANDHRA PRADESH
530048
India 
Phone  9949034599  
Fax  08912590131  
Email  drvalluritejasree@gmail.com  
 
Source of Monetary or Material Support  
Gayatri Vidya parishad institute of health care and medical technology, 6-25, Maridi valley, Marikavalasa, Madhurawada, Visakhapatnam, 530048, Andhra Pradesh 
 
Primary Sponsor  
Name  Gayatri Vidya parishad institute of health care and medical technology 
Address  Gayatri Vidya parishad institute of health care and medical technology, 6-25, Maridi valley, Marikavalasa, Madhurawada, Visakhapatnam, 530048, Andhra Pradesh 
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 Valluri Tejasree  Gayatri Vidya parishad institute of health care and medical technology  OT complex, 1st floor, Room no 12, Gayatri Vidya Parishad Institute of Health Care and Medical Technology, 6-25, Maridi valley, Marikavalasa, Madhurawada, Visakhapatnam, 530048, Andhra Pradesh
Visakhapatnam
ANDHRA PRADESH 		 9949034599

drvalluritejasree@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institutional ethics committee, GVPIHC & MT  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  Below umbilicus surgeries, lower limb surgeries, anorectal surgeries, (1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  1% Isobaric 2-chloroprocaine 4ml with 0.5% Hyperbaric bupivacaine 3ml given in Sub-arachnoid space through spinal needle for patients requiring spinal anaesthesia for below umbilicus surgical procedures lasting about 60minutes.   chloroprocaine is a amino-ester with very short half life, short acting local anaesthetic used for spinal anaesthetia for the increasing day care surgical procedures with good safety profile. Various local anaesthetics are used. Most common being hyperbaric bupivacaine which is a long acting agent. chloroprocaine is a short acting agent which helps in faster recovery from blockade and ambulation leading to early discharge and less complications. 
Intervention  Spinal anaesthesia given as a lumbar puncture into Sub-arachnoid space at L3-L3 or L3-L4 interspinous space.   Spinal Anaesthesia is the anesthetic technique used for surgical procedures involving abdominal and lower limb procedures.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  ASA I-III, Surgical procedures less than 60minutes ( 1 hour) , elective surgeries, below umbilicus procedures (lower limb, ano-rectal, urological, gynecological surgeries) 
 
ExclusionCriteria 
Details  patients with contraindications to spinal anaesthesia ( Platelet count < 75,000 , INR >1.5 , use of anti-coagulants, Spinal deformities,, sevre cardiac lesions) , age < 18years > 70years, surgeries lasting more than 60minutes,n patients under ASA IV, V, E, patients allergic or intolerant to local anaesthetic agent, patients who are not willing to be included in the study.  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
The duration of sensory and motor blockade.   5 minutes to 4 hours 
 
Secondary Outcome  
Outcome  TimePoints 
peak level of blockade, time until ambulation, time to reach eligibility criteria for discharge, complications like transient neurological symptoms (TNS)  5minutes to 12 hours 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   01/05/2018 
Date of Study Completion (India) 25/10/2018 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   1.Ben Gys et al. Intrathecal prilocaine, 2-chloroprocaine and bupivacaine for ambulatory abdominal wall herniorrhaphy: a prospective observational study, Ambulatory surgery 23.1 january 2017 2.Camponovo C et al. Intrathecal 1% 2-chloroprocaine vs. 0.5% bupivacaine in ambulatory surgery: a prospective, observer-blinded, randomised, controlled trial. Acta Anaesthesiol Scand. 2014 May;58(5):560-6 3.Daniela Ghisi et al. Ambulatory surgery with chloroprocaine spinal anesthesia: a review, Ambulatory anesthesia 2015:2 111-120. 4.Ying Zhang et al. The effect of different doses of chloroprocaine on saddle anesthesia in perianal surgery, 66 - Acta Cirúrgica Brasileira - Vol. 29 (1) 2014  
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   This is a prospective randomized double blind study, to compare the efficacy and duration of blockade of two local anaesthetics, 1% isobaric 2-chloroprocaine and 0.5% hyperbaric bupivacaine for spinal anaesthesia in day care surgeries and short duration procedures lasting 60 minutes, compared in 60 patients over 6 months duration in below umbilicus elective surgeries of ASA grade I-III of ages 18 to 70.  The secondary outcomes include peak level of blockade, time until ambulation and time to reach eligibility to discharge. It is to compare and provide a suitable alternative to low dose long acting local anaesthetics in spinal anaesthesia for ambulatory surgeries. 


 
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