FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2023/01/048983 [Registered on: 13/01/2023] Trial Registered Prospectively
Last Modified On: 07/01/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Pain relief after Gall bladder surgery with help of nerve block. 
Scientific Title of Study   COMPARATIVE ANALYSIS OF DURATION OF POST OPERATIVE ANALGESIA BETWEEN ROPIVACAINE ALONE AND ROPIVACAINE WITH DEXAMETHASONE FOR ULTRASOUND GUIDED TRANSVERSUS ABDOMINIS PLANE BLOCK IN PATIENTS UNDERGOING LAPAROSCOPIC CHOLECYSTECTOMY: A PROSPECTIVE, RANDOMIZED 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 Raghavendra Ullas L 
Designation  Post Graduate 
Affiliation  Rajarajeswari Medical college and Hospital 
Address  Department of Anaesthesiology Rajarajeswari Medical college and Hospital Mysore Road Kambipura Bangalore
441 1st D cross 3rd stage 4th block basaveshwaranagar Bangalore 560079
Bangalore
KARNATAKA
560074
India 
Phone  09901884491  
Fax    
Email  ullasable@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sudheer R 
Designation  Professor 
Affiliation  Rajarajeswari Medical college and Hospital 
Address  Department of Anaesthesiology Rajarajeswari Medical college and Hospital Mysore Road Kambipura Bangalore

Bangalore
KARNATAKA
560074
India 
Phone  9741117754  
Fax    
Email  sudheerramegowda81@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Karthik GS 
Designation  Professor 
Affiliation  Rajarajeswari Medical college and Hospital 
Address  Department of Anaesthesiology Rajarajeswari Medical college and Hospital Mysore Road Kambipura Bangalore

Bangalore
KARNATAKA
560074
India 
Phone  9538220515  
Fax    
Email  drgskarthik@gmail.com  
 
Source of Monetary or Material Support  
Rajarajeswari Medical college and Hospital 
 
Primary Sponsor  
Name  Dr Raghavendra Ullas L 
Address  Rajarajeswari Medical college and Hospital 
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 
Dr Raghavendra Ullas L  Rajarajeswari Medical college and Hospital  Department of ANAESTHESIOLOGY Rajarajeswari Medical college and Hospital Kambipura Bangalore
Bangalore
KARNATAKA 		 9901884491

ullasable@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  TRANSVERSE ABDOMINIS PLANE BLOCK after the completion of surgery  For LAPAROSCOPIC CHOLECYSTECTOMY patient will be followed up for 24 hours VAS score will be recorded every 2 hours and rescue analgesia will be given if VAS score is more than 4 . Time of first Rescue analgesia noted and comparing both the groups 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  1.ASA I to II patients.
2.Aged between 20 to 50 years.
3.Normal liver and renal function test, Coagulation profile.
4.Undergoing laparoscopic cholecystectomy under General anaesthesia.
 
 
ExclusionCriteria 
Details  1.Patients with history of allergy to local Anaesthetics.
2.Patients with history of mental disorders.
3.Patient Refusal.
4.Morbid obesity (BMI>40), Coagulopathy and significant cardiovascular respiratory, renal, hepatic or metabolic diseases or CNS disorders.
5.Infection at site of procedure.

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess the duration of Post operative analgesia using Ropivacaine (0.5%) alone and Ropivacaine with Dexamethasone in bilateral transversus abdominis plane block after general anesthesia for laparoscopic cholecystectomy.  To Note VAS score at 0,1,2,4,8,12,16,18,24 hours 
 
Secondary Outcome  
Outcome  TimePoints 
To compare Hemodynamic parameters and assess Post operative Visual analogue scale Pain score.  To Note VAS score at 0,1,2,4,8,12,16,18,24 hours 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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/ Phase 3 
Date of First Enrollment (India)   18/01/2023 
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)   Open to Recruitment 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

TAP block has been used as a Postoperative analgesia technique for Laparoscopic surgery where TAP block is given before the emergence from anesthesia which have proven to reduce postoperative opioid consumption and has helped in early mobilisation and reduce risk of complications. 

we intend to study that of addition of dexamethasone to ropivacaine in USG-TAP block enhances the duration of post operative analgesia significantly.

 
Close