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 |
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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 |
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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
|
|
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
|
|
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 |
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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. |