| CTRI Number |
CTRI/2016/12/007535 [Registered on: 05/12/2016] Trial Registered Retrospectively |
| Last Modified On: |
28/11/2016 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A randomised control trial comparing the efficacy of laparoscopic assisted TAP block for post operative pain relief with USG guided TAP block in patients undergoing laparoscopic cholecystectomy |
|
Scientific Title of Study
|
Laparoscopic Assisted Tranversus Abdominis Plane (TAP) Block Versus Ultrasonography Guided Transversus Abdominis Plane Block in Reducing Pain in Laparoscopic Cholecystectomy : Randomised Control Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
T R Niranjan |
| Designation |
junior resident , dept of general surgery |
| Affiliation |
JIPMER |
| Address |
JIPMER HOSPITAL ,
PONDICHERRY
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9790309037 |
| Fax |
|
| Email |
mezorit46@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sarath Chandra Sistla |
| Designation |
Professor, Dept of General surgery, JIPMER; Junior resident , dept of general surgery, JIPMER |
| Affiliation |
JIPMER |
| Address |
JIPMER HOSPITAL ,
PONDICHERRY
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9894013556 |
| Fax |
|
| Email |
sarathsistla@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
T R Niranjan |
| Designation |
junior resident , dept of general surgery |
| Affiliation |
JIPMER |
| Address |
JIPMER HOSPITAL ,
PONDICHERRY
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9790309037 |
| Fax |
|
| Email |
mezorit46@gmail.com |
|
|
Source of Monetary or Material Support
|
| DEPARTMENT OF GENERAL SURGERY,
JIPMER,
PONDICHERRY |
|
|
Primary Sponsor
|
| Name |
JIPMER |
| Address |
DEPARTMENT OF GENERAL SURGERY,
JIPMER,
PONDICHERRY-605006 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| NIRANJAN T R |
DEPARTMENT OF GENERAL SURGERY, OLD BUILDING, JIPMER HOSPITAL |
DEPARTMENT OF GENERAL SURGERY
2ND FLOOR
JIPMER
KORIMEDU
PONDICHERRY
Pondicherry
PONDICHERRY |
9790309037
mezorit46@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JIPMER ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Symptomatic cholelithiasis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Laparoscopic assisted transversus abdominis plane block |
In this group, local anaesthetics ( bupivacaine ) will be administered with the help of laparoscope, using a semi-blind technique, intra-operatively. |
| Comparator Agent |
USG guided transversus abdominis plane block |
In this group, local anaesthetics ( bupivacaine ) will be administered with the help of USG intra-operatively, before starting the surgery. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
All patients > 18  yrs        ASA 1 &2 |
|
| ExclusionCriteria |
|
|
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 efficacy of laparoscopic TAP block in reducing pain in laparoscopic cholecystectomy |
To assess the efficacy of laparoscopic TAP block in reducing pain in laparoscopic cholecystectomy assessed at 6,24 and 48 hours post-operatively
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the time taken for the administration of the block |
To compare the time taken for the administration of the block calculated from draping to administration of drug. |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 |
|
Date of First Enrollment (India)
|
09/11/2012 |
| 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="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The primary purpose of this study is to compare the efficacy of laparoscopic assisted Transversus abdominis plane (TAP) block with USG guided TAP block.HYPOTHESIS - laparoscopic assisted TAP block is as efficacious as USG guided TAP block in reducing pain in laparoscopic cholecystectomy patients
|