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CTRI Number  CTRI/2019/04/018484 [Registered on: 08/04/2019] Trial Registered Prospectively
Last Modified On: 06/04/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Other 
Public Title of Study   Comparison of two techniques, ultrasound guided tap block and port site infiltration with ropivacaine for pain relief following gall bladder surgeries  
Scientific Title of Study   Comparison of ultrasound guided bilateral transversus abdominis plane block versus port site infiltration with ropivacaine for post operative analgesia following laparoscopic 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 Umme Sarah 
Designation  Post graduate 
Affiliation  KIMS BANGALORE 
Address  Department of anaesthesiology, Kempegowda Institute Of Medical Sciences, V V Puram, Bangalore

Bangalore
KARNATAKA
560004
India 
Phone  9620626626  
Fax    
Email  sab_sarah91@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  DR VIJAYANAND 
Designation  Professor 
Affiliation  Kims, Bangalore 
Address  Department of anaesthesiology, Kempegowda Institute of Medical Sciences, Bangalore

Bangalore
KARNATAKA
560004
India 
Phone  9341231411  
Fax    
Email  isasecretary15@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Umme Sarah 
Designation  1st year Post graduate 
Affiliation  kims, bangalore 
Address  Department of Anaesthesiology, kempegowda Institute Of Medical Sciences , Bangalore

Bangalore
KARNATAKA
560004
India 
Phone  9620626626  
Fax    
Email  sab_sarah91@yahoo.com  
 
Source of Monetary or Material Support  
Umme Sarah Post graduate Kempegowda institute of medical sciences, K R road, V V Puram , Bangalore- 560004 
 
Primary Sponsor  
Name  Dr Umme Sarah 
Address  Kempegowda Institute of medical sciences, K R Road, V V puram , bangalore 560004 
Type of Sponsor  Other [Self] 
 
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 
Umme Sarah  Kempegowda Institute of Medical Sciences, Bangalore  Department of Anesthesiology, A block, 4th floor, KIMS Hospital, K R road, V V Puram, Bangalore
Bangalore
KARNATAKA 
9620626626

sab_sarah91@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KIMS BANGALORE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis, (2) ICD-10 Condition: K819||Cholecystitis, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  a study of 0.25% ropivacaine used for ultrasound guided tap block and posrt site infiltration in laparoscopic cholecystectomy surgeries  40 ml of 0.25% ropivacaine ( 20 ml on each side ) is deposite in usg guided TAP block and 20 ml of 0.25% ropivacaine ( 5 ml each in 4 ports ) for port site infiltration in patients coming for elective laparoscopic cholecystectomy surgeries 
Intervention  comparison of ultrasound guided transversus abdominis plane block with port site infiltration using ropivacaine for post operative analgesia   group 1 contains 40 patients which recieve usg guided TAP block bilaterally and group 2 contains 40 patients which receive port site infiltration with ropivacaine, to asses the NRS score and requirement of rescue analgesia after the laparoscopic cholecystectomy surgeries. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients posted for elective laparoscopic cholecystectomy, and ASA 1 and 2 ,  
 
ExclusionCriteria 
Details  Patient not willing to give consent,pregnancy and lactation,Coagulopathy, BMI less than 18 and more than 35, Known allergy to anaesthetic agent,Infection at the site of the block, Alcohol and drug abuse, Patients with chronic pain,Preoperative chronic dependance on opioid medications 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Duration of analgesia and Total analgesic requirement in the first 24 hours  Numerical rating Scale for pain will be assessed serially at 30 mins, 60 mins, 2 hours, 4 hours , 6 hours, 12 hours and 24 hours after the surgery.  
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   15/04/2019 
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="6"
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)?  

Brief Summary   The study is intended to study the effect of Ropivacaine for post operative analgesia in two tehniques, i.e, ultrsound guided transversus abdominis plane block and port site infiltration laparoscopic cholecystectomy surgeries using 0.25% ropivacaine. Here also time for rescue analgesia will be assessed. the sacle used to measure pain is Numerical Rating Score.  
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