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CTRI Number  CTRI/2013/12/004219 [Registered on: 16/12/2013] Trial Registered Retrospectively
Last Modified On: 13/10/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Role of epidural ropivacaine and ropivacaine -clonidine combination for infraumbilical surgery as postoperative analgesia 
Scientific Title of Study   "Comparison between epidural Ropivacaine and Ropivacaine Clonidine combination for infraumbilical surgeries.A prospective,randomized 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  DR NEERAJ KUMAR 
Designation  MD (PGT) Final Year 
Affiliation  INDIRA GANDHI INSTITUTE OF MEDICAL SCIENCES,SHEIKHPURA PATNA 
Address  MANVI HOME AHEAD SHYAMAL HOSPITAL ,URJA GRAM ,P.O:B.V.COLLEGE,P.S:RAJEEVNAGAR,KHAZPURA PATNA
DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE MEDICINE ,INDIRA GANDHI INSTITUTE OF MEDICAL SCIENCES(IGIMS)SHEIKHPURA PATNA-14 (BIHAR)
Patna
BIHAR
800014
India 
Phone  8294155124  
Fax    
Email  neeraj.jlnmc@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR AJIT GUPTA 
Designation  MD Anaesthesiology  
Affiliation  INDIRA GANDHI INSTITUTE OF MEDICAL SCIENCES,SHEIKHPURA PATNA 
Address  Additional proffesor DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE MEDICINE ,INDIRA GANDHI INSTITUTE OF MEDICAL SCIENCES(IGIMS)SHEIKHPURA PATNA-14 (BIHAR)
DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE MEDICINE ,INDIRA GANDHI INSTITUTE OF MEDICAL SCIENCES(IGIMS)SHEIKHPURA PATNA-14 (BIHAR)
Patna
BIHAR
800014
India 
Phone  09835225692  
Fax    
Email  ajpta_igims@yahoo.co.uk  
 
Details of Contact Person
Public Query  
Name  DR NEERAJ KUMAR 
Designation  MD (PGT) Final Year 
Affiliation  INDIRA GANDHI INSTITUTE OF MEDICAL SCIENCES,SHEIKHPURA PATNA 
Address  MANVI HOME AHEAD SHYAMAL HOSPITAL ,URJA GRAM ,P.O:B.V.COLLEGE,P.S:RAJEEVNAGAR,KHAZPURA PATNA
DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE MEDICINE ,INDIRA GANDHI INSTITUTE OF MEDICAL SCIENCES(IGIMS)SHEIKHPURA PATNA-14 (BIHAR)
Patna
BIHAR
800014
India 
Phone  8294155124  
Fax    
Email  neeraj.jlnmc@gmail.com  
 
Source of Monetary or Material Support  
Indira Gandhi institute of medical sciences ,sheikhpura patna (Department of anaesthesiology and critical care medicine) 
 
Primary Sponsor  
Name  DR NEERAJ KUMAR 
Address  DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE MEDICINE ,INDIRA GANDHI INSTITUTE OF MEDICAL SCIENCES(IGIMS)SHEIKHPURA PATNA-14 (BIHAR) 
Type of Sponsor  Other [INDIVIDUAL PATIENT] 
 
Details of Secondary Sponsor  
Name  Address 
IGIMS  DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE MEDICINE ,INDIRA GANDHI INSTITUTE OF MEDICAL SCIENCES(IGIMS)SHEIKHPURA PATNA-14 (BIHAR) 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR NEERAJ KUMAR  INDIRA GANDHI INSTITUTE OF MEDICAL SCIENCES PATNA  GIS OT,NEURO OT,NEW MODULAR OT (FIRST FLOOR-OT COMPLEX),DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE MEDICINE INDIRA GANDHI INSTITUTE OF MEDICAL SCIENCES(IGIMS)SHEIKHPURA
Patna
BIHAR 		 8294155124

neeraj.jlnmc@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IGIMS,SHEIKHPURA ,PATNA-14,BIHAR  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Healthy Human Volunteers  ASA I ASA II 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Not applicable  Not applicable 
Intervention  study arm I Epidural Ropivacaine Study arm II Epidural Ropivacaine and clonidine combination   Study arm I Dose Ropivacine 0.75% 20 ml Frequency single shot Route of administration Epidural Duration of therapy 7 to 8 hours Study arm II Dose Ropivacine 0.75% 20 ml clonidine 75mcg Frequency single shot Route of administration Epidural Duration of therapy 7 to 8 hours 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  I)Patient undergoing infraumbilical surgeries under regional anaesthesia
II)ASA grade I and II patients 
 
ExclusionCriteria 
Details  I)Patient Refusal
II)ASA grade III and IV patients
III)Any Hematological disorders
IV)Any bleeding,Coagulation abnormalities or Full anticoagulant therapy
V)Psychiatric disease ,DM,CAD any comorbid conditions
VI)H/O drug abuse and drug allergy to LA of amide types
VII)Any C/I to epidural anaesthesia 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
The addition of 75 µg clonidine to isobaric epidural ropivacaine results in longer, complete and effective analgesia with similar block properties and helped to reduce the effective dose of ropivacaine when compared with plain ropivacaine for infraumbilical surgeries  4-5 hours 
 
Secondary Outcome  
Outcome  TimePoints 
not applicable  NA 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/02/2012 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Open to Recruitment 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 Kumar N, Sanjeev O, Kumar A, Kant S, Verma VK, Gupta AK. Comparison between epidural ropivacaine and ropivacaine–clonidine combination for infraumbilical surgeries: A randomized clinical study. Indian J Pain [serial online] 2019 [cited 2020 Oct 13];33:81-5.  
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  		 Background:Neuraxial adjuvants augment the action of Local anaesthetics
Aims and Objective:  Aim to determine the quqlitative and quantitative aspects of epidural ropivacaine 0.75% and epidural ropivacaine 0.75% clonidine 75mcg combination for infraumbilical surgeries
Material and Methods: 80 patients of ASA-I and ASA-II grades aged between 18-60 years who underwent infraumbilical surgeries were included randomly into two clinical study groups comprising 40 patients in each study group.Epidural anaesthesia was administered with 20ml of ropivacaine 0.75%(GROUP-R) and 20 ml of epidural ropivacaine 0.75% and clonidine 75mcg combination(GROUP-RC).Parameters of observation are demographic data,onset of sensory ,onset of motor ,highest level of sensory block ,duration of motor block,duration of sensory analgesia and hemodynamic parameters like NIBP,HR,RR,SPo2 and adverse events were observed and recorded.
Result: Eighty patients were enrolled in this study and were subjected to statistical analysis.Groups were comparable with regard to demographic data and incidences of side effects except for the higher incidence of dry mouth in patients of RC group.Onset of analgesia was much shorter in RC group with prolonged duration of analgesia.The incidences of bradycardia and hypotension was more in RC group as compared to R group which was statistically significant.The dose requirement for postoperative period [ain relief was significantly lesser in RC group.
Conclusion: The addition of 75mcg clonidine to isobaric epidural ropivacaine results in longer,complete and effective analgesia with similar block properties and helped to reduce the effective dose of ropivacaine when compared with plain ropivacaine for infraumbilical surgeries.




 
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