| CTRI Number |
CTRI/2017/02/007819 [Registered on: 08/02/2017] Trial Registered Retrospectively |
| Last Modified On: |
07/02/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical study comparing pain and satisfaction among patients undergoing laparoscopic cholecystectomy surgery |
|
Scientific Title of Study
|
Randomised control trial comparing postoperative pain scores and patient satisfaction in patients undergoing 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 |
S Ramkiran |
| Designation |
Anesthetist |
| Affiliation |
AFMC pune |
| Address |
Department of Anesthesiology Armed Forces Medical College Sholapur road Pune
Pune
MAHARASHTRA
411040
India |
| Phone |
7263957169 |
| Fax |
|
| Email |
sramkiran44@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
S Ramkiran |
| Designation |
Anesthetist |
| Affiliation |
AFMC pune |
| Address |
Department Of Anesthesiology Armed Forces Medical College Sholapur Road Pune
Pune
MAHARASHTRA
411040
India |
| Phone |
7263957169 |
| Fax |
|
| Email |
sramkiran44@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
S Ramkiran |
| Designation |
Anesthetist |
| Affiliation |
AFMC pune |
| Address |
Department Of Anesthesiology Armed Forces Medical College Sholapur Road Pune
Pune
MAHARASHTRA
411040
India |
| Phone |
7263957169 |
| Fax |
|
| Email |
sramkiran44@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Armed Forces Medical College Sholapur Road Pune 411040 |
|
|
Primary Sponsor
|
| Name |
Self |
| Address |
Department Of Anesthesiology Armed Forces Medical College Sholapur Road Pune 411040 |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NONE |
NOT APPLICABLE |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr S Ramkiran |
Armed Forces Medical College Command Hospital Southern Command Pune |
Department Of Anesthesiology Armed Forces Medical College Sholapur road Pune 411040
Pune
MAHARASHTRA |
7263957169
sramkiran44@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Medical Research Wing Department Of Community Medicine Armed Forces Medical College Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients with symptomatic gallstone disease undergoing laparoscopic cholecystectomy surgery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Active Control group involving Port site Local anesthesia infiltration by the operating surgeon |
10 ml of 0.5% bupivacaine injected as a single dose over 10 minutes towards the end of surgery |
| Intervention |
Ultrasound guided Combined right Rectus sheath block with right Subcostal Transversus Abdominis Plane block |
40 ml 0.125% bupivacaine with 20 ml in each block injected as a single dose over a duration of 10 minutes towards the end of surgery |
| Intervention |
Ultrasound guided right subcostal transversus abdominis plane block alone |
20 ml of 0.25% bupivacaine injected as a single dose over 10 minutes towards the end of surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Symptomatic gall stone disease patient population undergoing primary laparoscopic cholecystectomy belonging to ASA I-III |
|
| ExclusionCriteria |
| Details |
Cardio-pulmonary compromise,morbid obesity,conversion to open cholecystectomy/laparotomy,anterior wall hernia defects,combination surgery,past surgery,abdominal trauma,pregnancy |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Postoperative Pain score measured by visual analog scale |
Postoperative pain score measured by visual analog scale 0,2,6,12,24 hours postoperative |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Patient Satisfaction Score |
12 and 24 hours postoperative |
| Need for rescue analgesia and its Dose |
24 hours postoperatively |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
14/04/2016 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a randomised, double blind, parallel group, active controlled trial utilising fixed permuted block randomisation technique. The study compares pain scores, patient satisfaction and need for rescue analgesia in patients undergoing laparoscopic cholecystectomy between three regional anesthesia block groups namely Ultrasound guided Right Subcostal TAP block , Ultrasound guided Combined Right Subcostal TAP with Rectus Sheath block and Surgeon administered Port site Local Anesthesia Infiltration. |