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CTRI Number  CTRI/2017/08/009340 [Registered on: 10/08/2017] Trial Registered Retrospectively
Last Modified On: 09/08/2017
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To study pain relieving effect of two medicine ropivacaine and dexamethasone after gall bladder removal. 
Scientific Title of Study   A study to compare postoperative analgesic efficacy of ropivacaine alone or in combination with dexamethasone for TAP Block in open cholecystectomy 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr SHASI KIRAN 
Designation  SENIOR PROFESSOR 
Affiliation  Deptt of Anaesthesia and critical care,PGIMS ROHTAK 
Address  Deptt. of Anaesthesia and critical care,Pt.B.D.SHARMA PGIMS ROHTAK
Deptt. of anaesthesia and critical care,Pt.B.D. SHARMA PGIMS ROHTAK
Rohtak
HARYANA
124001
India 
Phone  9416763899  
Fax    
Email  drshashi64@rediff.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr ARUNA 
Designation  JUNIOR RESIDENT 
Affiliation  Deptt of Anaesthesia and critical care,PGIMS ROHTAK 
Address  Deptt. of anaesthesia and critical care,Pt. B.D.SHARMA PGIMS ROHTAK
Deptt. of anaesthesia and critical care,Pt.B.D.SHARMA PGIMS ROHTAK
Rohtak
HARYANA
124001
India 
Phone  9729218522  
Fax    
Email  yadavaruna771@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr ARUNA 
Designation  JUNIOR RESIDENT 
Affiliation  Deptt of anesthesia and critical care,PGIMS ROHTAK 
Address  Deptt. of Anaesthesia and critical care,Pt. B.D.Sharma,PGIMS Rhotak
Deptt. of Anaesthesia and critical care,Pt.B.D.SHARMA PGIMS ROHTAK
Rohtak
HARYANA
124001
India 
Phone  9729218522  
Fax    
Email  yadavaruna771@gmail.com  
 
Source of Monetary or Material Support  
Pt B.D.Sharma PGIMS, RHOTAK 
 
Primary Sponsor  
Name  Pt BDSharma PGIMS ROHTAK 
Address  PGIMS ROHTAK 
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 
Dr SHASHI KIRAN  PGIMS ROHTAK  Pt.B.D.SHARMA PGIMS ROHTAK
Rohtak
HARYANA 
9416763899

drshashi64@rediff.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  HEALTHY,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  nil  nil 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ASA Grade 1-3 
 
ExclusionCriteria 
Details  1.Contraindication to regional anaesthesia
2.History of local anaesthetic allergy
3.Psychiatric disorder
4.BMI>35kg/sq.m
5.Diabetes Mellitus
6.Chronic opioid use
7.Patient refusal 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
twenty four hours Tramadol consumption  postoperative twenty four hours 
 
Secondary Outcome  
Outcome  TimePoints 
Time to first request for analgesic, VAS Score,Nausea Score, Sedation Score, Any side effect  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)   13/01/2016 
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="2"
Months="6"
Days="15" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   This study is a randomized, double blind, parallel group, trail comparing the postoperative analgesic efficacy of 18ml of 0.75% ropivacaine with 2ml of normal saline with 18 ml of o.75% ropivacaine with 2 ml of dexamethasone for TAP block in open cholecystectomy over 60 patients of ASA grade 1-3. The primary outcome will be 24 hr tramadol cosumption. The secondary outcome will be measure include VAS score, nausea score, sedation score and any side effect.
 
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