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CTRI Number  CTRI/2018/05/013963 [Registered on: 18/05/2018] Trial Registered Prospectively
Last Modified On: 17/05/2018
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   comparison of addition of Dexmedetomidine and clonidine to ropivacaine for blocking nerves using ultrasound for pain management after operation of hernia. 
Scientific Title of Study   Comparison of addition of Dexmedetomidine and Clonidine to Ropivacaine in ultrasound guided transversus abdominis plane block in patients undergoing open inguinal hernioplasty- RANDOMIZED, OPEN-LABELLED, COMPARATIVE CLINICAL STUDY.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shiwalika Gupta 
Designation  ASSISTANT PROFESSOR Anaesthesia  
Affiliation  PARUL INSTITUTE OF MEDICAL SCIENCE AND RESEARCH 
Address  Department Of Anaesthesia, Parul institute of medical science and research, Limda Village, Waghodia, Vadodara, Gujarat

Vadodara
GUJARAT
391760
India 
Phone  7227888526  
Fax    
Email  g.guptashiwalika@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Shiwalika Gupta 
Designation  ASSISTANT PROFESSOR Anaesthesia  
Affiliation  PARUL INSTITUTE OF MEDICAL SCIENCE AND RESEARCH 
Address  Department Of Anaesthesia, Parul institute of medical science and research waghodia vadodara

Vadodara
GUJARAT
391760
India 
Phone  7227888526  
Fax    
Email  g.guptashiwalika@gmail.com  
 
Details of Contact Person
Public Query  
Name  Shiwalika Gupta 
Designation  ASSISTANT PROFESSOR Anaesthesia  
Affiliation  PARUL INSTITUTE OF MEDICAL SCIENCE AND RESEARCH 
Address  Department Of Anaesthesia, Parul institute of medical science and research waghodia vadodara

Vadodara
GUJARAT
391760
India 
Phone  7227888526  
Fax    
Email  g.guptashiwalika@gmail.com  
 
Source of Monetary or Material Support  
PARUL INSTITUTE OF MEDICAL SCIENCE AND RESEARCH, Limda Village waghodia vadodara 391760 
 
Primary Sponsor  
Name  PARUL INSTITUTE OF MEDICAL SCIENCE AND RESEARCH 
Address  Parul university; limda Village, Tehsil:Waghodia; District:vadodara, Gujarat State. Pincode: 391760 
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 Shiwalika Gupta  PARUL Seashram Hospital   Department Of Anaesthesia, Parul institute of medical science and research, Village:limda,Tehsil: waghodia, District :vadodara, State:Gujarat
Vadodara
GUJARAT 		 7227888526

g.guptashiwalika@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
PARUL UNIVERSITY INSTITUTIONAL ETHICS COMMITTEE FOR HUMAN RESEARCH  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  patient posted for inguinal hernioplasty,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  clonidine plus ropivacaine  clonidine 1microgm/kg plus 0.2%ropivacaine 
Comparator Agent  dexmedtomidine plus ropivacaine,  dexmedtomidine 1micogm/kg plus0.2%ropivacaine  
Intervention  transversus abdominis plane block  ultrasound guided transversus abdominis plane block 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  open inguinal hernioplasty. 
 
ExclusionCriteria 
Details  allergic to study drugs. patients on renal, cardiac, liver disease. patients on bleeding diathesis. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
comparison of Visual analog score, Ramsay sedation score, changes in heart rate, BP, requirement of analgesic  comparison of Visual analog score, Ramsay sedation score 
 
Secondary Outcome  
Outcome  TimePoints 
adverse effects and complications.  hourly for 72hours 
 
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)   23/05/2018 
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 Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not applicable 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   Transversus abdominis plane block is a new regional anaesthetic technique that block the abdominal wall neural afferents by introducing local anesthetic into plane between the internal oblique and transversus abdominis muscles. The aim of study is to compare efficacy and safety of addition of clonidine(1 microgm/kg) versus dexmedetomidine (1micogm/kg) to 0.2%ropivacaine in ultrasound guided TAP block for postoperative analgesia in patients undergoing open inguinal hernioplasty. All patients will be randomized by Research randomizer software in two groups. After preoperative assesment and routine investigation patients will undego inguinal hernioplasty under spinal anaesthesia. postoperative usg guided TAP block will be given with Dexmedtomidine plus ropivacaine in Group A and clonidine plus ropivacaine in group B. heart rate, MAP, sedation, visual analog score, adverse effects will be observed in all patients. 
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