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CTRI Number  CTRI/2013/07/003825 [Registered on: 22/07/2013] Trial Registered Retrospectively
Last Modified On: 16/07/2013
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of two local anesthetics (ropivacaine and bupivacaine) in providing pain relief after Gall Bladder Surgery  
Scientific Title of Study   A RANDOMISED CONTROLLED TRIAL COMPARING THE EFFICACY OF BUPIVACAINE AND ROPIVACAINE IN ULTRASOUND GUIDED TRANSVERSUS ABDOMINIS PLANE (TAP) BLOCK FOR POSTOPERATIVE ANALGESIA IN 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 Shradha Sinha 
Designation  Post Graduate 
Affiliation  GMCH sector 32, CHD 
Address  Department of Anaesthesia Level V, Block D GMCH, Sector 32 Chandigarh

Chandigarh
CHANDIGARH
160047
India 
Phone  9888914106  
Fax    
Email  drshradhasinha@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sanjeev Palta 
Designation  Associate Professor 
Affiliation  GMCH, Sector 32, CHD 
Address  Department Of Anaesthesia Level V , Block D GMCH Chandigarh
1151- A, sector 32 B Chandigarh
Chandigarh
CHANDIGARH
160032
India 
Phone  09646121523  
Fax    
Email  sanjeev_palta@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Richa Saroa 
Designation  Assistant Professor 
Affiliation  GMCH, CHD 
Address  Department Of Anaesthesia Level V , Block D GMCH Chandigarh
1208, Sector 32 B Chandigarh
Chandigarh
CHANDIGARH
160032
India 
Phone  09646121513  
Fax    
Email  richajayant@rediffmail.com  
 
Source of Monetary or Material Support  
Government Medical College and Hospital, Chandigarh 
 
Primary Sponsor  
Name  Government Medical College and Hospital sector B chandigarh 
Address  Government Medical College and Hospital sector 32B chandigarh 
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 Shradha Sinha  Government Medical College and Hospital  Department of anaesthesia Level V, Block D, GMCH,Sector 32, Chandigarh
Chandigarh
CHANDIGARH 
9888914106

drshradhasinha@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee, government medical college and hospital, chandigarh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  undergoing laparoscopic cholecystectomy,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  bupivacaine hydrochloride  0.25% bupivacaine hydrochloride is deposited in the transversus abdominis plane under ultrasound guidance at a dose of 2 mg/kg body weight  
Comparator Agent  Ropivacaine Hydrochloride  0.375% Ropivacaine hydrochloride is deposited in the transversus abdominis plane under ultrasound guidance at a dose of 3 mg/kg body weight 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  50 - 75 kg BW, Physical status ASA I and II 
 
ExclusionCriteria 
Details  pregnancy, drug allergy, drug abuse, Conversion to open Cholecystectomy, mentally unstable patient, coagulation abnormality, patients with abdominal drain in situ 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To Assess relative efficacy of ropivacaine and bupivacaine for post operative analgesia using ultrasound guided TAP block in patients undergoing Laparoscopic cholecystectomy  10 min, 30 mins, 1 hr, 4 hrs, 8hrs, 12hrs and 24 hours 
 
Secondary Outcome  
Outcome  TimePoints 
Assess post opeartive Nausea and vomiting, Calculate total rescue analgesic and antiemetic used  24hrs 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   02/02/2010 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Background :Ttransversus abdominis plane (TAP) block is a regional analgesic technique that blocks abdominal neural afferents by introducing local anaesthetic into the neurofascial plane between internal oblique and the transversus abdominis muscles thereby reducing the post operative pain of abdominal surgeries.

Method :  We evaluated the relative efficacy of bupivacaine 0.25% and ropivacaine 0.375% in ultrasound guided TAP block for postoperative analgesia in laparoscopic cholecystectomy. 60 adult ASA I & II patients undergoing elective laparoscopic cholecystectomy were randomized using computer coded sealed envelope to recieve either USG TAP block with 0.25% bupivacaine or 0.375% ropivacaine at the end of surgical procedure prior to extubation. All patients were assessed for postoperative pain, nausea vomiting and rescue analgesic consumption for upto 24 hours in the postoperative period.

Result : patients receiving USG TAP block with ropivacaine had significantly lower visual analog scale pain scores at 10 min, 30 min and 1 hour as compared to patients receiving USG TAP block with bupivacaine. beyond that both drugs are equal in their efficacy with respect to postoperative analgesia and 24 hrs cumulative rescue analgesic requirement. there were no complications attributable to TAP block.

Conclusion : USG TAP block is an effective regional analgesic technique for postoperative pain relief in patients undergoing laparoscopic cholecystectomy. ropivacaine has early onset of analgesia and provides better quality of pain relief in the immediate postoperative period upto 1 hour in comparison to bupivacaine. thereafter, both the drugs are equal in their efficacy in terms of postoperative analgesia and 24 gours cumulative rescue analgesic requirement. 

 
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