CTRI Number |
CTRI/2019/04/018484 [Registered on: 08/04/2019] Trial Registered Prospectively |
Last Modified On: |
06/04/2019 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug |
Study Design |
Other |
Public Title of Study
|
Comparison of two techniques, ultrasound guided tap block and port site infiltration with ropivacaine for pain relief following gall bladder surgeries |
Scientific Title of Study
|
Comparison of ultrasound guided bilateral transversus abdominis plane block versus port site infiltration with ropivacaine for post operative analgesia following 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 Umme Sarah |
Designation |
Post graduate |
Affiliation |
KIMS BANGALORE |
Address |
Department of anaesthesiology, Kempegowda Institute Of Medical Sciences, V V Puram, Bangalore
Bangalore KARNATAKA 560004 India |
Phone |
9620626626 |
Fax |
|
Email |
sab_sarah91@yahoo.com |
|
Details of Contact Person Scientific Query
|
Name |
DR VIJAYANAND |
Designation |
Professor |
Affiliation |
Kims, Bangalore |
Address |
Department of anaesthesiology,
Kempegowda Institute of Medical Sciences, Bangalore
Bangalore KARNATAKA 560004 India |
Phone |
9341231411 |
Fax |
|
Email |
isasecretary15@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Umme Sarah |
Designation |
1st year Post graduate |
Affiliation |
kims, bangalore |
Address |
Department of Anaesthesiology, kempegowda Institute Of Medical Sciences , Bangalore
Bangalore KARNATAKA 560004 India |
Phone |
9620626626 |
Fax |
|
Email |
sab_sarah91@yahoo.com |
|
Source of Monetary or Material Support
|
Umme Sarah
Post graduate
Kempegowda institute of medical sciences, K R road, V V Puram , Bangalore- 560004 |
|
Primary Sponsor
|
Name |
Dr Umme Sarah |
Address |
Kempegowda Institute of medical sciences, K R Road, V V puram , bangalore 560004 |
Type of Sponsor |
Other [Self] |
|
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 |
Umme Sarah |
Kempegowda Institute of Medical Sciences, Bangalore |
Department of Anesthesiology, A block, 4th floor, KIMS Hospital, K R road, V V Puram, Bangalore Bangalore KARNATAKA |
9620626626
sab_sarah91@yahoo.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
KIMS BANGALORE |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis, (2) ICD-10 Condition: K819||Cholecystitis, unspecified, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
a study of 0.25% ropivacaine used for ultrasound guided tap block and posrt site infiltration in laparoscopic cholecystectomy surgeries |
40 ml of 0.25% ropivacaine ( 20 ml on each side ) is deposite in usg guided TAP block and 20 ml of 0.25% ropivacaine ( 5 ml each in 4 ports ) for port site infiltration in patients coming for elective laparoscopic cholecystectomy surgeries |
Intervention |
comparison of ultrasound guided transversus abdominis plane block with port site infiltration using ropivacaine for post operative analgesia |
group 1 contains 40 patients which recieve usg guided TAP block bilaterally and group 2 contains 40 patients which receive port site infiltration with ropivacaine, to asses the NRS score and requirement of rescue analgesia after the laparoscopic cholecystectomy surgeries. |
|
Inclusion Criteria
|
Age From |
20.00 Year(s) |
Age To |
65.00 Year(s) |
Gender |
Both |
Details |
Patients posted for elective laparoscopic cholecystectomy, and ASA 1 and 2 , |
|
ExclusionCriteria |
Details |
Patient not willing to give consent,pregnancy and lactation,Coagulopathy, BMI less than 18 and more than 35, Known allergy to anaesthetic agent,Infection at the site of the block, Alcohol and drug abuse, Patients with chronic pain,Preoperative chronic dependance on opioid medications |
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
Duration of analgesia and Total analgesic requirement in the first 24 hours |
Numerical rating Scale for pain will be assessed serially at 30 mins, 60 mins, 2 hours, 4 hours , 6 hours, 12 hours and 24 hours after the surgery. |
|
Secondary Outcome
|
Outcome |
TimePoints |
nil |
nil |
|
Target Sample Size
|
Total Sample Size="80" Sample Size from India="80"
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
|
N/A |
Date of First Enrollment (India)
|
15/04/2019 |
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="6" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
Nil |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
The study is intended to study the effect of Ropivacaine for post operative analgesia in two tehniques, i.e, ultrsound guided transversus abdominis plane block and port site infiltration laparoscopic cholecystectomy surgeries using 0.25% ropivacaine. Here also time for rescue analgesia will be assessed. the sacle used to measure pain is Numerical Rating Score. |