| CTRI Number |
CTRI/2019/07/020227 [Registered on: 17/07/2019] Trial Registered Prospectively |
| Last Modified On: |
08/03/2020 |
| 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 post operative pain using TAP block vs Port site infiltration in laparoscopic cholecysctectomy. |
|
Scientific Title of Study
|
Randomized controlled study to compare laparoscopically guided transversus abdominis plane block with Port site infiltration of local anaesthetic for post operative pain relief in laparoscopic cholecystectomy for chronic cholecystitis |
| Trial Acronym |
Lap TAP Block |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anubhav Vindal |
| Designation |
Professor, Department of Surgery |
| Affiliation |
Maulana Azad Medical college |
| Address |
Room no 215,B L taneja block
Department of surgery,
Maulana Azad medical college
Bahadurshah zafar marg
New Delhi
DELHI
110002
India |
| Phone |
9968604403 |
| Fax |
|
| Email |
anubhav.vindal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anubhav vindal |
| Designation |
Professor of surgery |
| Affiliation |
Maulana Azad Medical college |
| Address |
Department of surgery,
2nd floor,Bl taneja block,
Maulana Azad medical college, bahadurshah Zafar Marg,
New Delhi
New Delhi
DELHI
110002
India |
| Phone |
9968604403 |
| Fax |
|
| Email |
anubhav.vindal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Hitesh sarda |
| Designation |
Post graduate |
| Affiliation |
Maulana Azad Medical college |
| Address |
Room No 215,
Department of surgery
B L Taneja block,
Maulana Azad medical college, Bahadurshah Zafar Marg,
New Delhi
New Delhi
DELHI
110002
India |
| Phone |
9844111799 |
| Fax |
|
| Email |
hitesh.frenship@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College
Bahadurshah Zafar Marg
New Delhi-110002 |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College |
| Address |
Bahadurshah Zafar Marg
New Delhi - 110002 |
| 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 Anubhav Vindal |
Maulana Azad medical college |
Department of surgery
Bl taneja block
Maulana Azad medical college
Bahadurshah Zafar Marg
New Delhi
New Delhi
DELHI |
9968604403
anubhav.vindal@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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Port site infiltration of bupivacaine |
40 ml 0.25% bupivacaine infiltrated at 4 ports 10 ml each after closure of skin |
| Intervention |
TAP block with bupivacaine |
40 ml 0.25% bupivacaine infiltrated under laparoscopic guidance at 4 pre operatively marked sites, 10 ml each after laparoscopic cholecystectomy |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
All patients of confirmed cholelithiasis proven on USG without complications
ASA grade 1 and 2 |
|
| ExclusionCriteria |
| Details |
Opioid use
Alcohol abuse
Conversion to open surgery
Psychiatric illness
Allergy to bupivacaine
Cholelithiasis with CBD stone
Previous abdominal surgery
Complicated gall stone disease |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Post operative pain assessment |
3,6,24,discharge,1week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Time to return to daily activities
Post op hospital stay
Patient satisfaction |
7 days |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/07/2019 |
| Date of Study Completion (India) |
20/09/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="15" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study aims to compare post operative pain relief after laparoscopic cholecysctectomy in individuals receiving laparoscopic guided TAP block vs port site infiltration of bupivacaine with respect to resumption of activities of daily living and patient satisfaction. |